Automated Impella Controller (AIC), used in left heart support blood pump, including the followin...
FDA Device Recall #Z-2164-2025 — Class I — June 23, 2025
Recall Summary
| Recall Number | Z-2164-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | June 23, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abiomed, Inc. |
| Location | Danvers, MA |
| Product Type | Devices |
| Quantity | 11,031 units |
Product Description
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.
Reason for Recall
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Distribution Pattern
Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Lot / Code Information
1. Product Code: 0042-0000-AU; GTIN Number: 813502010886; Serial Numbers: IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6526, IC6527, IC6528, IC6529, IC6530, IC6531, IC5622, IC5677, IC5752, IC5836, IC5341, IC5521, IC5522, IC5523, IC5524, IC5525, IC5237, IC5216, IC5217, IC5236, IC5238. 2. Product Code: 0042-0000-CA; GTIN Number: 813502011272; Serial Numbers: IC9416, IC9414, IC9415, IC9413, IC8283, IC7695, IC7716, IC7694, IC6633, IC6634, IC6635, IC6636, IC6082, IC6083, IC5821, IC5824, IC5680, IC5034, IC5050, IC4944, IC4945, IC3802, IC3803, IC3661, IC3662, IC2686, IC2687, IC2369, IC2370, IC2033, IC2035, IC2032, IC2034, IC1911, IC1912, IC1913, IC1790, IC1791, IC1715, IC1769, IC1664, IC1665, IC1595, IC1598, IC1572, IC1543, IC1544, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN Number: 813502011289; Serial Numbers: IC7809, IC7717, IC7718, IC7719, IC7720, IC7721, IC7748, IC7674, IC7675, IC7686, IC7687, IC7688, IC7689, IC7690, IC7691, IC7692, IC7693, IC7653, IC7654, IC7655, IC7666, IC7667, IC7646, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7613, IC7614, IC7615, IC7421, IC7576, IC7577, IC7578, IC7579, IC7580, IC7581, IC7582, IC7583, IC7584, IC7455, IC7452, IC7453, IC7454, IC7378, IC7388, IC7389, IC7390, IC7392, IC7393, IC7394, IC7407, IC7395, IC7406, IC7263, IC7264, IC7265, IC7286, IC7258, IC7259, IC7260, IC7261, IC7262, IC7087, IC7092, IC7093, IC7094, IC7095, IC7096, IC7097, IC7098, IC7099, IC7100, IC7075, IC7076, IC7077, IC7078, IC6843, IC6844, IC6845, IC6876, IC6877, IC6878, IC6879, IC6880, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6810, IC6812, IC6813, IC6814, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6710, IC6711, IC6712, IC6713, IC6714, IC6715, IC6716, IC6717, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6708, IC6709, IC6587, IC6588, IC6589, IC6590, IC6591, IC6592, IC6593, IC6594, IC6595, IC6577, IC6578, IC6579, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6510, IC6449, IC6469, IC6474, IC6487, IC6488, IC6489, IC6437, IC6439, IC6440, IC6441, IC6443, IC6431, IC6432, IC6435, IC6436, IC6434, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6270, IC6331, IC6205, IC6214, IC6216, IC6293, IC6294, IC6272, IC6273, IC6274, IC6275, IC6223, IC6224, IC6225, IC6236, IC6164, IC6165, IC6147, IC6148, IC6149, IC6150, IC6151, IC6078, IC6081, IC6079, IC6080, IC6064, IC6076, IC5817, IC5818, IC5774, IC5775, IC5777, IC5779, IC5781, IC5780, IC5754, IC5755, IC5756, IC5757, IC5611, IC5714, IC5715, IC5716, IC5717, IC5722, IC5681, IC5682, IC5683, IC5684, IC5685, IC5686, IC5688, IC5687, IC5559, IC5560, IC5558, IC5517, IC5518, IC5519, IC5520, IC5495, IC5496, IC5487, IC5488, IC5489, IC5490, IC5491, IC5492, IC5493, IC5494, IC5476, IC5477, IC5357, IC5465, IC5466, IC5467, IC5460, IC5461, IC5462, IC5463, IC5464, IC5440, IC5441, IC5442, IC5443, IC5433, IC5434, IC5435, IC5436, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5251, IC5252, IC5193, IC5194, IC5195, IC5210, IC5212, IC5169, IC5171, IC5173, IC5174, IC5175, IC5176, IC5177, IC5178, IC5051, IC5053, IC5075, IC5086, IC5087, IC5088, IC5046, IC5047, IC5048, IC5049, IC5057, IC5055, IC4973, IC5007, IC5008, IC5009, IC4984, IC4986, IC4987, IC4988, IC4850, IC4928, IC4929, IC4930, IC4931, IC4932, IC4933, IC4934, IC4911, IC4912, IC4913, IC4914, IC4915, IC4916, IC4917, IC4845, IC4846, IC4833, IC4834, IC4835, IC4836, IC4837, IC4839, IC4840, IC4823, IC4824, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4790, IC4791, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4781, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4723, IC4724, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4725, IC4727, IC4728, IC4729, IC4677, IC4678, IC4679, IC4680, IC4681, IC4682, IC4645, IC4646, IC4647, IC4648, IC4649, IC4656, IC4657, IC4658, IC4585, IC4630, IC4631, IC4632, IC4633, IC4634, IC4635, IC4636, IC4623, IC4624, IC4626, IC4627, IC4628, IC4629, IC4609, IC4610, IC4611, IC4612, IC4613, IC4614, IC4594, IC4595, IC4597, IC4598, IC4557, IC4565, IC4566, IC4567, IC4568, IC4569, IC4559, IC4560, IC4561, IC4562, IC4563, IC4564, IC4500, IC4501, IC4502, IC4503, IC4505, IC4506, IC4507, IC4508, IC4464, IC4465, IC4466, IC4467, IC4468, IC4469, IC4470, IC4471, IC4442, IC4443, IC4444, IC4445, IC4446, IC4365, IC4366, IC4367, IC4370, IC4371, IC4356, IC4357, IC4358, IC4359, IC4360, IC4361, IC4362, IC4363, IC4322, IC4323, IC4324, IC4325, IC4326, IC4328, IC4329, IC4251, IC4252, IC4253, IC4254, IC4255, IC4256, IC4257, IC4258, IC4235, IC4236, IC4237, IC4238, IC4241, IC4242, IC4240, IC4233, IC4227, IC4228, IC4229, IC4230, IC4231, IC4232, IC4234, IC4217, IC4218, IC4207, IC4208, IC4209, IC4210, IC4211, IC4212, IC4175, IC4146, IC4147, IC4148, IC4149, IC4150, IC4151, IC4152, IC4153, IC4128, IC4129, IC4096, IC4097, IC4098, IC4099, IC4100, IC4081, IC4083, IC4068, IC4069, IC4054, IC4055, IC4036, IC4037, IC4033, IC4034, IC4035, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3885, IC3886, IC3887, IC3888, IC3889, IC3891, IC3884, IC3890, IC3868, IC3869, IC3870, IC3871, IC3872, IC3874, IC3875, IC3873, IC3859, IC3861, IC3862, IC3863, IC3864, IC3866, IC3867, IC3860, IC3828, IC3829, IC3830, IC3831, IC3833, IC3834, IC3832, IC3815, IC3816, IC3817, IC3818, IC3812, IC3813, IC3814, IC3777, IC3778, IC3780, IC3781, IC3782, IC3783, IC3776, IC3779, IC3717, IC3724, IC3718, IC3719, IC3720, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3704, IC3705, IC3696, IC3697, IC3698, IC3699, IC3700, IC3702, IC3657, IC3667, IC3668, IC3669, IC3670, IC3671, IC3672, IC3673, IC3663, IC3664, IC3665, IC3666, IC3492, IC3493, IC3495, IC3656, IC3658, IC3659, IC3494, IC3660, IC3477, IC3485, IC3486, IC3487, IC3488, IC3489, IC3491, IC3490, IC3484, IC3466, IC3467, IC3468, IC3469, IC3470, IC3471, IC3472, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3313, IC3319, IC3323, IC3329, IC3330, IC3331, IC3332, IC3327, IC3328, IC3314, IC3315, IC3316, IC3317, IC3318, IC3321, IC3322, IC3324, IC3304, IC3305, IC3306, IC3307, IC3308, IC3309, IC3310, IC3311, IC3296, IC3297, IC3298, IC3299, IC3300, IC3303, IC3301, IC3302, IC3286, IC3287, IC3288, IC3289, IC3290, IC3291, IC3292, IC3184, IC3178, IC3179, IC3180, IC3181, IC3182, IC3183, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3127, IC3128, IC3129, IC3130, IC3133, IC3134, IC3131, IC3132, IC3095, IC3096, IC3097, IC3098, IC3100, IC3101, IC3099, IC3102, IC3067, IC3068, IC3069, IC3070, IC3048, IC3049, IC3051, IC3052, IC3053, IC3054, IC3050, IC3015, IC3016, IC3017, IC3018, IC3019, IC3020, IC3021, IC3022, IC2996, IC2997, IC2984, IC2985, IC2987, IC2988, IC2989, IC2960, IC2961, IC2962, IC2963, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2878, IC2855, IC2856, IC2858, IC2859, IC2862, IC2860, IC2861, IC2835, IC2836, IC2837, IC2838, IC2823, IC2824, IC2825, IC2826, IC2828, IC2829, IC2830, IC2827, IC2763, IC2766, IC2767, IC2765, IC2755, IC2756, IC2757, IC2758, IC2753, IC2754, IC2751, IC2752, IC2676, IC2677, IC2678, IC2679, IC2708, IC2709, IC2710, IC2712, IC2668, IC2669, IC2670, IC2652, IC2653, IC2654, IC2655, IC2656, IC2657, IC2658, IC2659, IC2606, IC2607, IC2609, IC2610, IC2559, IC2491, IC2512, IC2534, IC2560, IC2471, IC2481, IC2483, IC2484, IC2485, IC2486, IC2490, IC2494, IC2475, IC2476, IC2477, IC2478, IC2479, IC2469, IC2470, IC2472, IC2473, IC2474, IC2556, IC2557, IC2441, IC2442, IC2443, IC2444, IC2411, IC2412, IC2413, IC2414, IC2380, IC2325, IC2326, IC2327, IC2329, IC2330, IC2331, IC2332, IC2266, IC2267, IC2268, IC2239, IC2240, IC2241, IC2242, IC2243, IC2244, IC2245, IC2231, IC2232, IC2233, IC2234, IC2235, IC2236, IC2220, IC2221, IC2222, IC2219, IC2204, IC2205, IC2206, IC2207, IC2171, IC2172, IC2173, IC2174, IC2178, IC2179, IC2175, IC2095, IC2096, IC2097, IC2098, IC2099, IC2100, IC2101, IC2102, IC2021, IC2038, IC2039, IC2040, IC2005, IC2006, IC1971, IC1972, IC1973, IC1974, IC1975, IC1976, IC1977, IC1978, IC1901, IC1902, IC1903, IC1904, IC1905, IC1907, IC1908, IC1775, IC1780, IC1881, IC1886, IC1870, IC1872, IC1874, IC1871, IC1876, IC1821, IC1822, IC1823, IC1824, IC1825, IC1826, IC1761, IC1763, IC1764, IC1765, IC1766, IC1767, IC1768, IC1720, IC1721, IC1722, IC1723, IC1726, IC1727, IC1724, IC1725, IC1699, IC1700, IC1677, IC1678, IC1684, IC1685, IC1676, IC1653, IC1584, IC1585, IC1587, IC1588, IC1590, IC1591, IC1592, IC1593, IC1594, IC1586, IC1578, IC1579, IC1580, IC1577, IC1546, IC1547, IC1548, IC1549, IC1522, IC1523, IC1524, IC1525, IC1488, IC1490, IC1413, IC1415, IC1411, IC1416, IC1395, IC1396, IC1397, IC1398, IC1393, IC1381, IC1383, IC1384, IC1385, IC1386, IC1347, IC1349, IC1350, IC1340, IC1341, IC1343, IC1344, IC1345, IC1301, IC1302, IC1304, IC1305, IC1284, IC1288, IC1283, IC1285, IC1276, IC1277, IC1278, IC1280, IC1275, IC1265, IC1216, IC1217. 4. Product Code: 0042-0000-EU-L; GTIN Number: 813502011289; Serial Numbers: IC7810, IC6065, IC4910, IC4901, IC4891, IC4892, IC4875, IC4876, IC4879, IC4880, IC4881, IC4874, IC4877, IC4878, IC4867, IC4868, IC4869, IC4870, IC4871, IC4872, IC4873, IC4866, IC4855, IC4847, IC4848, IC4849, IC4851, IC4852, IC4853, IC4838, IC4622, IC4625, IC4364, IC4239, IC4032, IC3827, IC3320, IC2986, IC2857, IC2176, IC1906, IC1762, IC1520, IC1521, IC1487, IC1399, IC1303, IC1011. 5. Product Code: 0042-0000-IN; GTIN Number: 813502011418; Serial Numbers: IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6475, IC6476, IC6477, IC6478, IC6139, IC6252, IC6253, IC6254. 6. Product Code: 0042-0000-JP; GTIN Number: 813502010428; Serial Numbers: IC8276, IC8277, IC8278, IC8279, IC8280, IC8281, IC8282, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8047, IC8048, IC8049, IC8050, IC8051, IC8052, IC8053, IC8054, IC8055, IC8076, IC8077, IC8085, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7928, IC7929, IC7902, IC7903, IC7904, IC7905, IC7926, IC7927, IC7899, IC7900, IC7901, IC7852, IC7853, IC7854, IC7855, IC7896, IC7897, IC7898, IC7851, IC7812, IC7813, IC7814, IC7815, IC7846, IC7808, IC7811, IC7784, IC7785, IC7806, IC7779, IC7780, IC7781, IC7782, IC7783, IC7746, IC7747, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7593, IC7594, IC7595, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7433, IC7434, IC7435, IC7439, IC7440, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7291, IC7293, IC7294, IC7295, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6468, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6202, IC6203, IC6204, IC6210, IC6211, IC6212, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6091, IC6046, IC6047, IC6048, IC6049, IC5929, IC5930, IC5935, IC5936, IC5937, IC5938, IC5928, IC5864, IC5865, IC5866, IC5867, IC5868, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5478, IC5447, IC5444, IC5445, IC5259, IC5260, IC5261, IC5241, IC5243, IC5245, IC5027, IC4732. 7. Product Code: 0042-0000-JP-L; GTIN Number: 813502010428; Serial Numbers: IC7448, IC7449, IC7391, IC7432, IC7436, IC7437, IC7438, IC7418, IC7419, IC7428, IC7292, IC7101, IC7086, IC7088, IC6881, IC6884, IC6655, IC6608, IC6609, IC6539, IC6532, IC6493, IC6494, IC6207, IC6209, IC5931, IC5932, IC5934, IC5869, IC5730, IC5508, IC5509, IC5513, IC5514, IC5258, IC5246, IC5029, IC5030, IC5031, IC4730. 8. Product Code: 0042-0000-UK; GTIN Number: 813502011296; Serial Numbers: IC7847, IC7848, IC7668, IC7669, IC7670, IC7671, IC7585, IC7591, IC7444, IC7445, IC7446, IC7447, IC7441, IC7442, IC7443, IC7072, IC7069, IC7070, IC7071, IC7073, IC7074, IC7056, IC7057, IC6934, IC6925, IC6924, IC6638, IC6669, IC6670, IC6671, IC6583, IC6584, IC6585, IC6586, IC6537, IC6538, IC6542, IC6543, IC6540, IC6286, IC6287, IC6289, IC6290, IC6291, IC6292, IC6001, IC5995, IC5996, IC5997, IC5998, IC5999, IC5914, IC5915, IC5911, IC5912, IC5926, IC5927, IC5910, IC5830, IC5831, IC5832, IC5833, IC5553, IC5554, IC5555, IC5557, IC5253, IC5254, IC5180, IC5211, IC5213, IC5247, IC5240, IC5218, IC5219, IC5220, IC5214, IC5215, IC5179, IC5181, IC5182, IC5184, IC4926, IC4927, IC4856, IC4857, IC4841, IC4842, IC4843, IC4844, IC4739, IC4741, IC4721, IC4722, IC4676, IC4675, IC4599, IC4600, IC4525, IC4438, IC4439, IC4440, IC4441, IC4330, IC4331, IC4082, IC4166, IC3784, IC3785, IC3674, IC3675, IC3475, IC3474, IC3464, IC3465, IC3333, IC3334, IC3325, IC3326, IC3312, IC3293, IC3294, IC3295, IC3174, IC2871, IC2872, IC2704, IC2705, IC2706, IC2707, IC2492, IC2493, IC2497, IC2496, IC2367, IC2368, IC2277, IC2278, IC2023, IC2024, IC2025, IC1909, IC1910, IC1868, IC1869, IC1792, IC1573, IC1581, IC1582, IC1583, IC1545, IC1542, IC1519, IC1494, IC1387, IC1388, IC1389, IC1391, IC1392. 9. Product Code: 0042-0000-UK-L; GTIN Number: 813502011296; Serial Numbers: IC7776, IC7777, IC7778, IC7592, IC3175, IC1576, IC1493. 10. Product Code: 0042-0000-US; GTIN Number: 813502010022; Serial Numbers: IC7919, IC7922, IC7028, IC7030, IC7032, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6982, IC6983, IC6984, IC7026, IC7027, IC6926, IC6927, IC6928, IC6929, IC6930, IC6931, IC6932, IC6933, IC6935, IC6914, IC6915, IC6916, IC6917, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6904, IC6905, IC6906, IC6907, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6889, IC6893, IC6894, IC6895, IC6896, IC6897, IC6898, IC6899, IC6900, IC6901, IC6833, IC6836, IC6837, IC6838, IC6839, IC6840, IC6841, IC6842, IC6834, IC6835, IC6811, IC6829, IC6831, IC6832, IC6830, IC6815, IC6826, IC6827, IC6828, IC6796, IC6797, IC6798, IC6799, IC6800, IC6801, IC6802, IC6803, IC6864, IC6865, IC6850, IC6851, IC6852, IC6853, IC6854, IC6824, IC6847, IC6848, IC6849, IC6825, IC6846, IC6774, IC6775, IC6816, IC6817, IC6818, IC6819, IC6820, IC6822, IC6823, IC6732, IC6753, IC6754, IC6755, IC6766, IC6767, IC6768, IC6769, IC6770, IC6771, IC6772, IC6773, IC6743, IC6744, IC6726, IC6727, IC6729, IC6730, IC6731, IC6733, IC6734, IC6735, IC6736, IC6737, IC6718, IC6719, IC6720, IC6721, IC6722, IC6723, IC6724, IC6725, IC6678, IC6679, IC6680, IC6681, IC6682, IC6683, IC6684, IC6685, IC6686, IC6687, IC6672, IC6674, IC6675, IC6676, IC6677, IC6673, IC6663, IC6664, IC6665, IC6666, IC6667, IC6668, IC6639, IC6640, IC6641, IC6643, IC6644, IC6645, IC6646, IC6647, IC6648, IC6649, IC6637, IC6624, IC6625, IC6626, IC6627, IC6628, IC6629, IC6630, IC6631, IC6632, IC6611, IC6612, IC6613, IC6614, IC6615, IC6616, IC6617, IC6618, IC6619, IC6620, IC6621, IC6622, IC6623, IC6515, IC6598, IC6599, IC6600, IC6601, IC6602, IC6603, IC6604, IC6596, IC6597, IC6562, IC6563, IC6564, IC6565, IC6566, IC6567, IC6568, IC6569, IC6570, IC6571, IC6572, IC6573, IC6574, IC6575, IC6576, IC6557, IC6558, IC6559, IC6560, IC6561, IC6544, IC6545, IC6546, IC6547, IC6511, IC6512, IC6513, IC6514, IC6516, IC6517, IC6518, IC6520, IC6521, IC6522, IC6523, IC6524, IC6525, IC6500, IC6502, IC6503, IC6504, IC6505, IC6506, IC6507, IC6508, IC6509, IC6495, IC6496, IC6497, IC6498, IC6499, IC6501, IC6428, IC6445, IC6446, IC6447, IC6448, IC6433, IC6438, IC6479, IC6480, IC6481, IC6482, IC6483, IC6484, IC6485, IC6486, IC6470, IC6471, IC6472, IC6473, IC6444, IC6450, IC6453, IC6454, IC6455, IC6408, IC6409, IC6410, IC6411, IC6412, IC6413, IC6414, IC6415, IC6426, IC6427, IC6390, IC6391, IC6392, IC6393, IC6394, IC6395, IC6396, IC6397, IC6398, IC6399, IC6400, IC6401, IC6402, IC6404, IC6403, IC6361, IC6362, IC6363, IC6364, IC6365, IC6366, IC6367, IC6368, IC6369, IC6360, IC6288, IC6295, IC6352, IC6353, IC6354, IC6355, IC6356, IC6357, IC6358, IC6359, IC6332, IC6333, IC6334, IC6335, IC6346, IC6347, IC6348, IC6349, IC6350, IC6351, IC6323, IC6324, IC6325, IC6326, IC6327, IC6330, IC6321, IC6322, IC6328, IC6329, IC6095, IC6317, IC6318, IC6319, IC6320, IC6255, IC6266, IC6267, IC6268, IC6269, IC6271, IC6242, IC6243, IC6244, IC6245, IC6246, IC6247, IC6248, IC6249, IC6250, IC6251, IC5933, IC6237, IC6238, IC6239, IC6240, IC6241, IC6206, IC6208, IC6213, IC6215, IC6217, IC6218, IC6219, IC6220, IC6221, IC6222, IC6045, IC6192, IC6193, IC6194, IC6195, IC6196, IC6197, IC6198, IC6200, IC6201, IC6199, IC6184, IC6185, IC6186, IC6187, IC6188, IC6189, IC6190, IC6191, IC6176, IC6177, IC6178, IC6179, IC6180, IC6181, IC6182, IC6183, IC6152, IC6153, IC6154, IC6155, IC6156, IC6157, IC6158, IC6159, IC6160, IC6161, IC6115, IC6135, IC6137, IC6138, IC6140, IC6141, IC6144, IC6145, IC6146, IC6128, IC6129, IC6130, IC6131, IC6132, IC6133, IC6134, IC6136, IC6142, IC6143, IC6103, IC6104, IC6105, IC6106, IC6107, IC6092, IC6093, IC6094, IC6096, IC6097, IC6098, IC6099, IC6100, IC6101, IC6102, IC6077, IC6059, IC6050, IC6051, IC6052, IC6053, IC6054, IC6055, IC6056, IC6057, IC6058, IC6060, IC6061, IC6062, IC6063, IC6000, IC6034, IC6035, IC6036, IC6037, IC6038, IC6039, IC6040, IC6041, IC6043, IC6044, IC6042, IC6002, IC6003, IC6004, IC6005, IC6026, IC6027, IC6028, IC6029, IC6030, IC6031, IC6032, IC6033, IC5565, IC5983, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, IC5991, IC5992, IC5993, IC5994, IC5984, IC5953, IC5954, IC5955, IC5976, IC5977, IC5978, IC5979, IC5980, IC5981, IC5982, IC5945, IC5946, IC5947, IC5948, IC5949, IC5950, IC5951, IC5952, IC5939, IC5940, IC5941, IC5942, IC5943, IC5944, IC5843, IC5889, IC5890, IC5891, IC5892, IC5893, IC5894, IC5895, IC5906, IC5907, IC5908, IC5909, IC5881, IC5882, IC5883, IC5884, IC5885, IC5886, IC5887, IC5888, IC5776, IC5778, IC5794, IC5838, IC5880, IC5870, IC5871, IC5872, IC5873, IC5874, IC5875, IC5876, IC5877, IC5878, IC5879, IC5848, IC5849, IC5850, IC5851, IC5852, IC5853, IC5854, IC5855, IC5856, IC5857, IC5858, IC5859, IC5839, IC5840, IC5841, IC5842, IC5844, IC5845, IC5846, IC5847, IC5816, IC5822, IC5823, IC5825, IC5826, IC5827, IC5829, IC5828, IC5787, IC5788, IC5789, IC5790, IC5791, IC5792, IC5793, IC5795, IC5766, IC5767, IC5768, IC5769, IC5770, IC5772, IC5773, IC5771, IC5758, IC5759, IC5760, IC5761, IC5762, IC5763, IC5764, IC5765, IC5746, IC5747, IC5748, IC5745, IC5749, IC5750, IC5736, IC5737, IC5738, IC5739, IC5740, IC5741, IC5742, IC5743, IC5718, IC5719, IC5723, IC5724, IC5725, IC5726, IC5720, IC5721, IC5704, IC5705, IC5706, IC5707, IC5708, IC5709, IC5710, IC5711, IC5712, IC5713, IC5701, IC5702, IC5703, IC5692, IC5693, IC5694, IC5695, IC5696, IC5697, IC5698, IC5699, IC5609, IC5690, IC5691, IC5599, IC5621, IC5623, IC5663, IC5664, IC5676, IC5678, IC5661, IC5662, IC5598, IC5549, IC5605, IC5607, IC5608, IC5619, IC5620, IC5624, IC5625, IC5564, IC5617, IC5647, IC5648, IC5649, IC5650, IC5655, IC5562, IC5596, IC5602, IC5603, IC5613, IC5614, IC5615, IC5616, IC5561, IC5597, IC5600, IC5601, IC5604, IC5606, IC5610, IC5612, IC5536, IC5537, IC5538, IC5539, IC5540, IC5541, IC5542, IC5543, IC5544, IC5545, IC5546, IC5547, IC5548, IC5550, IC5551, IC5552, IC5498, IC5499, IC5501, IC5502, IC5503, IC5504, IC5500, IC5497, IC5244, IC5479, IC5480, IC5481, IC5482, IC5483, IC5484, IC5485, IC5486, IC5468, IC5469, IC5470, IC5471, IC5472, IC5473, IC5474, IC5475, IC5453, IC5454, IC5455, IC5456, IC5457, IC5458, IC5459, IC5425, IC5393, IC5394, IC5395, IC5416, IC5417, IC5418, IC5419, IC5420, IC5365, IC5366, IC5367, IC5368, IC5369, IC5370, IC5371, IC5372, IC5373, IC5374, IC5375, IC5386, IC5387, IC5388, IC5389, IC5390, IC5345, IC5358, IC5359, IC5360, IC5361, IC5362, IC5363, IC5364, IC5336, IC5337, IC5338, IC5339, IC5340, IC5342, IC5343, IC5344, IC5319, IC5320, IC5321, IC5322, IC5323, IC5324, IC5325, IC5326, IC5327, IC5328, IC5329, IC5330, IC5332, IC5333, IC5334, IC5335, IC5311, IC5312, IC5313, IC5314, IC5315, IC5316, IC5317, IC5318, IC5242, IC5304, IC5305, IC5306, IC5307, IC5308, IC5309, IC5310, IC5271, IC5297, IC5298, IC5299, IC5300, IC5301, IC5302, IC5303, IC5289, IC5290, IC5291, IC5292, IC5293, IC5294, IC5295, IC5296, IC5270, IC5272, IC5273, IC5274, IC5275, IC5286, IC5287, IC5288, IC5262, IC5263, IC5264, IC5265, IC5266, IC5267, IC5268, IC5269, IC5170, IC5172, IC5206, IC5221, IC5222, IC5223, IC5224, IC5225, IC5188, IC5189, IC5190, IC5191, IC5192, IC5203, IC5204, IC5205, IC5207, IC5208, IC5209, IC5056, IC5201, IC5183, IC5185, IC5196, IC5197, IC5198, IC5199, IC5200, IC5202, IC5003, IC5150, IC5166, IC5167, IC5168, IC5024, IC5052, IC5124, IC5125, IC5146, IC5147, IC5148, IC5149, IC5151, IC5152, IC5153, IC5154, IC5155, IC5095, IC5116, IC5117, IC5118, IC5119, IC5122, IC5123, IC5120, IC5069, IC5070, IC5072, IC5090, IC5091, IC5092, IC5093, IC5094, IC4807, IC5054, IC5058, IC5059, IC5060, IC5063, IC5068, IC5089, IC5061, IC5062, IC5064, IC5066, IC5067, IC5071, IC5073, IC5074, IC5019, IC5017, IC5018, IC5015, IC4997, IC4998, IC4999, IC5001, IC5002, IC5004, IC5005, IC5006, IC4989, IC4990, IC4991, IC4992, IC4993, IC4994, IC4995, IC4996, IC4965, IC4969, IC4970, IC4972, IC4974, IC4980, IC4981, IC4982, IC4956, IC4971, IC4975, IC4976, IC4977, IC4978, IC4979, IC4983, IC4941, IC4943, IC4962, IC4963, IC4964, IC4966, IC4967, IC4968, IC4854, IC4935, IC4936, IC4937, IC4938, IC4939, IC4940, IC4942, IC4918, IC4919, IC4920, IC4921, IC4922, IC4923, IC4924, IC4925, IC4902, IC4903, IC4904, IC4905, IC4906, IC4907, IC4908, IC4909, IC4861, IC4885, IC4886, IC4887, IC4888, IC4889, IC4890, IC4893, IC4894, IC4895, IC4896, IC4897, IC4898, IC4899, IC4900, IC4884, IC4858, IC4859, IC4860, IC4862, IC4863, IC4864, IC4865, IC4825, IC4826, IC4827, IC4828, IC4829, IC4830, IC4831, IC4832, IC4798, IC4799, IC4800, IC4801, IC4802, IC4803, IC4804, IC4805, IC4806, IC4808, IC4809, IC4810, IC4811, IC4812, IC4813, IC4814, IC4782, IC4783, IC4784, IC4785, IC4786, IC4787, IC4788, IC4789, IC4772, IC4773, IC4774, IC4775, IC4776, IC4777, IC4778, IC4779, IC4764, IC4765, IC4766, IC4767, IC4768, IC4769, IC4770, IC4771, IC4749, IC4750, IC4751, IC4752, IC4753, IC4754, IC4755, IC4756, IC4744, IC4705, IC4706, IC4707, IC4709, IC4710, IC4711, IC4712, IC4713, IC4714, IC4717, IC4718, IC4719, IC4720, IC4708, IC4715, IC4716, IC4697, IC4698, IC4699, IC4700, IC4701, IC4702, IC4703, IC4704, IC4596, IC4690, IC4691, IC4693, IC4694, IC4695, IC4696, IC4692, IC4588, IC4683, IC4684, IC4685, IC4686, IC4687, IC4688, IC4689, IC4667, IC4668, IC4669, IC4670, IC4671, IC4672, IC4673, IC4674, IC4659, IC4660, IC4661, IC4662, IC4663, IC4664, IC4665, IC4666, IC4637, IC4638, IC4639, IC4642, IC4643, IC4644, IC4640, IC4641, IC4615, IC4617, IC4618, IC4619, IC4620, IC4621, IC4616, IC4601, IC4602, IC4603, IC4604, IC4605, IC4606, IC4607, IC4608, IC4591, IC4593, IC4577, IC4578, IC4579, IC4580, IC4581, IC4582, IC4583, IC4584, IC4488, IC4570, IC4571, IC4572, IC4573, IC4574, IC4575, IC4576, IC4504, IC4549, IC4551, IC4554, IC4555, IC4556, IC4558, IC4534, IC4535, IC4536, IC4537, IC4538, IC4539, IC4540, IC4541, IC4542, IC4543, IC4544, IC4546, IC4547, IC4548, IC4550, IC4552, IC4545, IC4526, IC4527, IC4528, IC4529, IC4530, IC4531, IC4532, IC4533, IC4509, IC4510, IC4511, IC4512, IC4513, IC4514, IC4515, IC4516, IC4517, IC4518, IC4519, IC4520, IC4521, IC4522, IC4523, IC4524, IC4483, IC4484, IC4485, IC4486, IC4487, IC4489, IC4490, IC4491, IC4492, IC4493, IC4494, IC4495, IC4496, IC4497, IC4498, IC4499, IC4472, IC4473, IC4474, IC4475, IC4476, IC4477, IC4478, IC4479, IC4480, IC4481, IC4482, IC4456, IC4457, IC4458, IC4459, IC4460, IC4461, IC4462, IC4463, IC4451, IC4452, IC4453, IC4454, IC4455, IC4432, IC4433, IC4434, IC4435, IC4436, IC4437, IC4430, IC4431, IC4422, IC4423, IC4424, IC4425, IC4426, IC4427, IC4428, IC4429, IC4413, IC4414, IC4415, IC4416, IC4417, IC4418, IC4419, IC4420, IC4405, IC4406, IC4407, IC4408, IC4409, IC4410, IC4411, IC4412, IC4397, IC4398, IC4399, IC4400, IC4401, IC4402, IC4403, IC4404, IC4389, IC4390, IC4391, IC4392, IC4393, IC4394, IC4395, IC4396, IC4381, IC4382, IC4383, IC4386, IC4387, IC4380, IC4372, IC4373, IC4374, IC4375, IC4377, IC4378, IC4379, IC4376, IC4348, IC4349, IC4350, IC4351, IC4352, IC4353, IC4354, IC4340, IC4341, IC4342, IC4343, IC4344, IC4345, IC4346, IC4347, IC4333, IC4334, IC4336, IC4337, IC4339, IC4314, IC4315, IC4316, IC4317, IC4318, IC4320, IC4321, IC4306, IC4307, IC4308, IC4309, IC4310, IC4311, IC4312, IC4313, IC4298, IC4299, IC4300, IC4301, IC4302, IC4303, IC4304, IC4305, IC4290, IC4291, IC4292, IC4293, IC4294, IC4297, IC4295, IC4278, IC4279, IC4280, IC4281, IC4282, IC4283, IC4284, IC4285, IC4275, IC4276, IC4277, IC4268, IC4269, IC4270, IC4271, IC4272, IC4273, IC4274, IC4260, IC4261, IC4262, IC4263, IC4264, IC4265, IC4266, IC4267, IC4259, IC4243, IC4244, IC4245, IC4246, IC4247, IC4248, IC4249, IC4250, IC4219, IC4220, IC4221, IC4222, IC4223, IC4224, IC4225, IC4226, IC4199, IC4200, IC4201, IC4202, IC4203, IC4204, IC4205, IC4206, IC4191, IC4192, IC4193, IC4194, IC4195, IC4196, IC4197, IC4198, IC4167, IC4168, IC4169, IC4170, IC4171, IC4172, IC4173, IC4174, IC4158, IC4159, IC4160, IC4161, IC4162, IC4163, IC4164, IC4165, IC4130, IC4131, IC4132, IC4133, IC4134, IC4135, IC4136, IC4137, IC4109, IC4110, IC4111, IC4112, IC4113, IC4114, IC4115, IC4116, IC4101, IC4102, IC4103, IC4104, IC4105, IC4106, IC4107, IC4108, IC4084, IC4085, IC4087, IC4088, IC4089, IC4090, IC4091, IC4070, IC4071, IC4072, IC4073, IC4074, IC4075, IC4076, IC4077, IC4061, IC4062, IC4063, IC4064, IC4065, IC4066, IC4067, IC4060, IC4038, IC4039, IC4040, IC4043, IC4044, IC4041, IC4042, IC4045, IC4024, IC4025, IC4026, IC4027, IC4028, IC4029, IC4030, IC4031, IC4016, IC4018, IC4019, IC4020, IC4021, IC4022, IC4023, IC4003, IC4004, IC4005, IC4007, IC4008, IC4009, IC4010, IC4011, IC3994, IC3995, IC3996, IC3997, IC3998, IC3999, IC4000, IC4001, IC3766, IC3986, IC3988, IC3989, IC3990, IC3991, IC3992, IC3993, IC3979, IC3980, IC3981, IC3982, IC3983, IC3984, IC3985, IC3987, IC3969, IC3970, IC3971, IC3972, IC3973, IC3974, IC3975, IC3976, IC3961, IC3962, IC3963, IC3964, IC3965, IC3966, IC3967, IC3968, IC3865, IC3954, IC3955, IC3956, IC3957, IC3958, IC3959, IC3960, IC3946, IC3947, IC3948, IC3949, IC3950, IC3951, IC3952, IC3953, IC3939, IC3940, IC3941, IC3942, IC3943, IC3944, IC3945, IC3931, IC3932, IC3933, IC3934, IC3935, IC3936, IC3937, IC3938, IC3923, IC3924, IC3925, IC3926, IC3927, IC3928, IC3929, IC3930, IC3915, IC3916, IC3917, IC3918, IC3919, IC3920, IC3921, IC3922, IC3907, IC3908, IC3909, IC3910, IC3911, IC3912, IC3913, IC3914, IC3900, IC3901, IC3902, IC3903, IC3904, IC3906, IC3892, IC3893, IC3894, IC3895, IC3896, IC3897, IC3898, IC3899, IC3876, IC3877, IC3878, IC3879, IC3880, IC3881, IC3882, IC3883, IC3851, IC3852, IC3853, IC3854, IC3855, IC3856, IC3857, IC3858, IC3843, IC3844, IC3845, IC3846, IC3847, IC3848, IC3849, IC3850, IC3835, IC3836, IC3837, IC3838, IC3839, IC3840, IC3841, IC3842, IC3819, IC3820, IC3821, IC3824, IC3825, IC3826, IC3822, IC3823, IC3804, IC3805, IC3807, IC3808, IC3809, IC3810, IC3811, IC3806, IC3794, IC3795, IC3796, IC3797, IC3798, IC3799, IC3800, IC3801, IC3786, IC3787, IC3788, IC3789, IC3790, IC3791, IC3792, IC3793, IC3768, IC3769, IC3770, IC3771, IC3774, IC3775, IC3772, IC3773, IC3749, IC3750, IC3751, IC3752, IC3753, IC3754, IC3755, IC3756, IC3741, IC3742, IC3743, IC3744, IC3745, IC3746, IC3747, IC3748, IC3733, IC3734, IC3735, IC3736, IC3737, IC3738, IC3739, IC3740, IC3725, IC3726, IC3727, IC3728, IC3729, IC3730, IC3731, IC3732, IC3694, IC3695, IC3710, IC3711, IC3712, IC3713, IC3714, IC3715, IC3686, IC3687, IC3688, IC3689, IC3690, IC3691, IC3693, IC3679, IC3680, IC3681, IC3682, IC3683, IC3684, IC3685, IC3643, IC3644, IC3645, IC3646, IC3647, IC3648, IC3649, IC3650, IC3635, IC3636, IC3637, IC3638, IC3640, IC3641, IC3642, IC3627, IC3628, IC3629, IC3630, IC3631, IC3632, IC3633, IC3634, IC3564, IC3610, IC3622, IC3623, IC3624, IC3625, IC3626, IC3609, IC3599, IC3600, IC3601, IC3602, IC3603, IC3604, IC3589, IC3590, IC3591, IC3592, IC3594, IC3595, IC3596, IC3575, IC3576, IC3577, IC3578, IC3579, IC3580, IC3581, IC3582, IC3567, IC3568, IC3569, IC3570, IC3571, IC3572, IC3573, IC3574, IC3561, IC3562, IC3563, IC3565, IC3566, IC3542, IC3543, IC3544, IC3545, IC3546, IC3547, IC3548, IC3549, IC3550, IC3551, IC3552, IC3553, IC3554, IC3555, IC3556, IC3557, IC3523, IC3524, IC3525, IC3526, IC3527, IC3528, IC3529, IC3530, IC3515, IC3516, IC3517, IC3518, IC3519, IC3520, IC3521, IC3522, IC3507, IC3508, IC3509, IC3510, IC3511, IC3512, IC3513, IC3514, IC3499, IC3500, IC3501, IC3502, IC3503, IC3504, IC3505, IC3506, IC3451, IC3452, IC3453, IC3454, IC3455, IC3496, IC3497, IC3498, IC3443, IC3444, IC3445, IC3446, IC3447, IC3448, IC3449, IC3450, IC3436, IC3437, IC3438, IC3439, IC3440, IC3441, IC3427, IC3428, IC3429, IC3432, IC3433, IC3434, IC3419, IC3420, IC3421, IC3422, IC3423, IC3424, IC3425, IC3426, IC3349, IC3412, IC3413, IC3414, IC3415, IC3416, IC3417, IC3418, IC3404, IC3405, IC3406, IC3407, IC3408, IC3409, IC3410, IC3411, IC3346, IC3354, IC3378, IC3379, IC3347, IC3351, IC3394, IC3396, IC3397, IC3399, IC3400, IC3401, IC3384, IC3385, IC3386, IC3388, IC3390, IC3374, IC3375, IC3376, IC3377, IC3380, IC3381, IC3382, IC3383, IC3366, IC3367, IC3368, IC3369, IC3370, IC3371, IC3372, IC3373, IC3358, IC3359, IC3360, IC3361, IC3362, IC3363, IC3364, IC3365, IC3345, IC3348, IC3350, IC3352, IC3353, IC3355, IC3356, IC3357, IC3336, IC3337, IC3338, IC3339, IC3340, IC3341, IC3343, IC3342, IC3278, IC3279, IC3281, IC3282, IC3283, IC3284, IC3285, IC3280, IC3270, IC3271, IC3272, IC3273, IC3274, IC3275, IC3276, IC3277, IC3219, IC3261, IC3262, IC3263, IC3266, IC3267, IC3268, IC3269, IC3253, IC3254, IC3255, IC3257, IC3258, IC3259, IC3260, IC3214, IC3215, IC3216, IC3217, IC3218, IC3220, IC3221, IC3222, IC3245, IC3247, IC3248, IC3249, IC3250, IC3251, IC3252, IC3246, IC3229, IC3230, IC3231, IC3232, IC3233, IC3234, IC3235, IC3236, IC3237, IC3238, IC3239, IC3242, IC3243, IC3241, IC3240, IC3244, IC3212, IC3224, IC3225, IC3226, IC3227, IC3228, IC3213, IC3223, IC3204, IC3205, IC3206, IC3207, IC3208, IC3209, IC3210, IC3211, IC3196, IC3197, IC3198, IC3199, IC3200, IC3201, IC3202, IC3203, IC3166, IC3167, IC3186, IC3187, IC3188, IC3189, IC3191, IC3192, IC3193, IC3194, IC3185, IC3168, IC3169, IC3170, IC3171, IC3172, IC3173, IC3176, IC3177, IC3158, IC3159, IC3160, IC3161, IC3162, IC3163, IC3164, IC3165, IC3150, IC3151, IC3152, IC3153, IC3156, IC3157, IC3154, IC3155, IC2978, IC3135, IC3136, IC3137, IC3138, IC3139, IC3140, IC3141, IC3119, IC3120, IC3121, IC3122, IC3123, IC3124, IC3125, IC3126, IC3111, IC3112, IC3113, IC3114, IC3115, IC3116, IC3117, IC3118, IC3103, IC3104, IC3105, IC3106, IC3107, IC3108, IC3109, IC3110, IC3087, IC3088, IC3089, IC3090, IC3091, IC3092, IC3093, IC3094, IC3079, IC3080, IC3081, IC3082, IC3083, IC3084, IC3085, IC3086, IC3063, IC3064, IC3065, IC3066, IC3071, IC3072, IC3073, IC3074, IC3075, IC3076, IC3077, IC3078, IC3055, IC3056, IC3057, IC3058, IC3059, IC3060, IC3061, IC3062, IC3039, IC3040, IC3041, IC3042, IC3043, IC3044, IC3045, IC3046, IC3031, IC3032, IC3033, IC3034, IC3035, IC3036, IC3037, IC3038, IC3023, IC3024, IC3025, IC3026, IC3027, IC3028, IC3029, IC3030, IC3006, IC3007, IC3008, IC3011, IC3012, IC3013, IC3009, IC3010, IC2998, IC2999, IC3000, IC3001, IC3002, IC3003, IC3004, IC3005, IC2982, IC2983, IC2990, IC2991, IC2992, IC2993, IC2994, IC2995, IC2973, IC2974, IC2975, IC2979, IC2980, IC2981, IC2976, IC2977, IC2965, IC2966, IC2969, IC2970, IC2971, IC2972, IC2949, IC2950, IC2951, IC2952, IC2953, IC2954, IC2955, IC2956, IC2731, IC2942, IC2943, IC2944, IC2945, IC2946, IC2947, IC2948, IC2934, IC2935, IC2936, IC2937, IC2938, IC2939, IC2940, IC2941, IC2926, IC2927, IC2928, IC2929, IC2930, IC2931, IC2932, IC2933, IC2918, IC2919, IC2920, IC2921, IC2922, IC2923, IC2924, IC2925, IC2711, IC2914, IC2915, IC2916, IC2917, IC2913, IC2907, IC2908, IC2909, IC2910, IC2887, IC2888, IC2889, IC2890, IC2891, IC2892, IC2893, IC2895, IC2896, IC2897, IC2898, IC2899, IC2901, IC2879, IC2880, IC2881, IC2882, IC2883, IC2884, IC2885, IC2886, IC2863, IC2865, IC2866, IC2867, IC2868, IC2869, IC2870, IC2847, IC2848, IC2849, IC2850, IC2851, IC2852, IC2853, IC2854, IC2839, IC2842, IC2843, IC2844, IC2845, IC2
Other Recalls from Abiomed, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1470-2026 | Class I | Impella RP Flex with SmartAssist. Product Code:... | Jan 27, 2026 |
| Z-1471-2026 | Class I | Impella RP. Product Code: 0046-0011. | Jan 27, 2026 |
| Z-1469-2026 | Class I | Impella RP with SmartAssist. Product Code: 0046... | Jan 27, 2026 |
| Z-1030-2026 | Class II | Impella 5.5 with SmartAssist¿ S2, Impella 5.5 w... | Dec 4, 2025 |
| Z-0069-2026 | Class I | Automated Impella Controller (AIC), used for le... | Oct 1, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.