HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU...
FDA Device Recall #Z-1570-2025 — Class I — March 13, 2025
Recall Summary
| Recall Number | Z-1570-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | March 13, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Thoratec LLC |
| Location | Pleasanton, CA |
| Product Type | Devices |
| Quantity | 1661 |
Product Description
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Reason for Recall
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC, KY, CA, IL, WI, TX, MA, AR, MS, MI, OH, FL, NC, TN, LA, NJ, UT, NY, DE, CT, GA, IN, AZ, OK, MO, OR, MN, SC, NM, MD, IA, KS, AL, CO, ME and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CZECH REPUBLIC, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, ISRAEL, ITALY, JAPAN, KUWAIT, LEBANON, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, ROMANIA, SERBIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UK, UNITED ARAB EMIRATES.
Lot / Code Information
UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. Serial Numbers: 20226263, 20226264, 20226265, 20226266, 20226267, 20226268, 20226269, 20226270, 20226271, 20226272, 20226273, 20226274, 20226275, 20226276, 20226277, 20226278, 20226279, 20226280, 20226281, 20226282, 20226283, 20226284, 20226285, 20226286, 20226287, 20226288, 20226289, 20226290, 20226291, 20226292, 20240622, 20240623, 20240624, 20240625, 20240626, 20240627, 20240628, 20240629, 20240630, 20240631, 20240632, 20240633, 20240634, 20240635, 20240636, 20240637, 20240638, 20240639, 20240640, 20240641, 20240642, 20240643, 20240644, 20240645, 20240646, 20240647, 20240648, 20240649, 20240650, 20240651, 20240652, 20240653, 20240654, 20240655, 20240656, 20240657, 20240658, 20240659, 20240660, 20240661, 20240662, 20240663, 20240664, 20240665, 20240666, 20240667, 20240668, 20240669, 20240670, 20240671, 20240672, 20240673, 20240674, 20240675, 20240676, 20240677, 20240678, 20240679, 20240680, 20240681, 20240682, 20240683, 20240684, 20240685, 20240686, 20240687, 20240688, 20240689, 20240690, 20240691, 20254123, 20254124, 20254125, 20254126, 20254127, 20254128, 20254129, 20254130, 20254131, 20254132, 20254133, 20254134, 20254135, 20254136, 20254137, 20254138, 20254139, 20254140, 20254141, 20254142, 20254143, 20254144, 20254145, 20254146, 20254147, 20254148, 20254149, 20254150, 20254151, 20254152, 20254153, 20254154, 20254155, 20254156, 20254157, 20254158, 20254159, 20254160, 20254161, 20254162, 20254166, 20254167, 20254168, 20254169, 20254170, 20254171, 20254172, 20254173, 20254174, 20254175, 20254176, 20254177, 20254178, 20254179, 20254180, 20254181, 20254182, 20265454, 20265455, 20265456, 20265457, 20265458, 20265459, 20265460, 20265461, 20265462, 20265463, 20265464, 20265465, 20265466, 20265467, 20265468, 20265469, 20265470, 20265471, 20265472, 20265473, 20265474, 20265475, 20265476, 20265477, 20265478, 20265479, 20265480, 20265481, 20265483, 20265484, 20265485, 20265486, 20265487, 20265488, 20265489, 20265490, 20265491, 20265492, 20265493, 20265494, 20265495, 20265496, 20265497, 20265498, 20265499, 20265500, 20265501, 20265502, 20265503, 20265504, 20265505, 20265506, 20265507, 20265508, 20265509, 20265510, 20265511, 20265512, 20265513, 20265514, 20265515, 20265516, 20265517, 20265518, 20265519, 20265520, 20265521, 20265522, 20265523, 20265524, 20265525, 20265526, 20265527, 20265528, 20265529, 20265530, 20265531, 20265532, 20265533, 20265534, 20265535, 20265536, 20265537, 20265538, 20265539, 20265540, 20265541, 20265542, 20265543, 20265544, 20265545, 20265546, 20265547, 20265548, 20265549, 20265550, 20265551, 20265552, 20265553, 20265554, 20265555, 20265556, 20265557, 20265558, 20265559, 20265560, 20265561, 20265562, 20265563, 20265564, 20265565, 20265566, 20265567, 20265568, 20265569, 20265570, 20265571, 20265572, 20265573, 20265574, 20265576, 20265577, 20265578, 20265579, 20265580, 20265581, 20265582, 20265583, 20265584, 20265585, 20265586, 20265587, 20265588, 20265589, 20265590, 20265591, 20265592, 20265593, 20265594, 20265595, 20265596, 20265597, 20265598, 20265599, 20265600, 20265601, 20265602, 20265603, 20265604, 20265605, 20265606, 20265607, 20265608, 20265609, 20265610, 20265611, 20265612, 20265613, 20265614, 20265615, 20265616, 20265617, 20265618, 20265619, 20265620, 20265621, 20265622, 20265623, 20265624, 20265625, 20265626, 20265627, 20265628, 20265629, 20265630, 20265631, 20265632, 20265633, 20265634, 20265635, 20265636, 20265638, 20265639, 20265641, 20265642, 20265643, 20265644, 20273242, 20273243, 20273244, 20273245, 20273246, 20273247, 20273248, 20273249, 20273250, 20273251, 20273252, 20273253, 20273254, 20273255, 20273256, 20273257, 20273258, 20273259, 20273260, 20273261, 20273262, 20273263, 20273264, 20273265, 20273266, 20273267, 20273268, 20273269, 20273270, 20273271, 20285420, 20285421, 20285422, 20285423, 20285424, 20285425, 20285426, 20285427, 20285428, 20285429, 20285430, 20285431, 20285432, 20285433, 20285434, 20285435, 20285436, 20285437, 20285438, 20285439, 20285461, 20285463, 20285464, 20285465, 20285467, 20285468, 20285469, 20285470, 20285471, 20285472, 20285473, 20285475, 20285476, 20285477, 20285478, 20285479, 20285480, 20285481, 20285483, 20285484, 20285485, 20285486, 20285487, 20285488, 20285489, 20285490, 20285491, 20285492, 20285493, 20285494, 20285495, 20285496, 20285497, 20285498, 20285499, 20285500, 20285501, 20285502, 20285503, 20285569, 20285570, 20285571, 20285572, 20285573, 20285574, 20285575, 20285576, 20285577, 20285578, 20285589, 20285590, 20285591, 20285592, 20285593, 20285594, 20285595, 20285596, 20285597, 20285598, 20285599, 20285600, 20285601, 20285602, 20285603, 20285604, 20285605, 20285606, 20285608, 20285609, 20291598, 20291599, 20291600, 20291601, 20291602, 20291603, 20291604, 20291605, 20291606, 20291607, 20291608, 20291609, 20291610, 20291611, 20291612, 20291613, 20291614, 20291615, 20291616, 20291617, 20291618, 20291619, 20291620, 20291621, 20291622, 20291623, 20291624, 20291625, 20291627, 20291628, 20291629, 20291630, 20291631, 20291632, 20291633, 20291634, 20291635, 20291636, 20291637, 20293120, 20293121, 20293122, 20293123, 20293124, 20293125, 20293126, 20293127, 20293128, 20293129, 20293130, 20293131, 20293132, 20293133, 20293134, 20293135, 20293136, 20293137, 20293138, 20293139, 20293140, 20293141, 20293142, 20293143, 20293144, 20293145, 20293146, 20293147, 20293148, 20293149, 20293150, 20293151, 20293152, 20293153, 20293154, 20293155, 20293156, 20293157, 20293158, 20293159, 20296547, 20296548, 20296549, 20296550, 20296551, 20296552, 20296553, 20296555, 20296556, 20296557, 20296559, 20296560, 20296561, 20296563, 20296564, 20296565, 20296566, 20296567, 20296568, 20296569, 20296571, 20296572, 20296573, 20296574, 20296575, 20296576, 20296577, 20297159, 20297160, 20297161, 20297162, 20297163, 20297164, 20297165, 20297166, 20297167, 20297168, 20302246, 20302247, 20302248, 20302249, 20302250, 20302251, 20302252, 20302254, 20302255, 20302256, 20302257, 20302258, 20302260, 20302261, 20302262, 20302264, 20302265, 20302266, 20302267, 20302268, 20302269, 20302270, 20302272, 20302273, 20302274, 20302275, 20302276, 20302277, 20302278, 20302279, 20302280, 20302281, 20302282, 20302284, 20302285, 20302287, 20302288, 20302289, 20302290, 20302291, 20302292, 20302293, 20302294, 20302295, 20302297, 20302298, 20302299, 20302300, 20302301, 20302302, 20302303, 20302304, 20302305, 20302307, 20302308, 20302309, 20302310, 20302311, 20302312, 20302313, 20302314, 20302315, 20302316, 20302317, 20302318, 20302319, 20302320, 20302321, 20302322, 20302323, 20302324, 20302325, 20302326, 20302327, 20302328, 20302329, 20302330, 20302331, 20302332, 20302333, 20302334, 20302335, 20302336, 20302337, 20302338, 20302339, 20302340, 20302341, 20302342, 20302343, 20302344, 20302345, 20302346, 20302347, 20302348, 20302349, 20302350, 20302351, 20302352, 20302353, 20302354, 20302355, 20307844, 20307845, 20307846, 20307847, 20307848, 20307849, 20307850, 20307851, 20307852, 20307853, 20307854, 20307855, 20307856, 20307857, 20307858, 20307859, 20307860, 20307861, 20307862, 20307863, 20307864, 20307865, 20307866, 20307867, 20307868, 20307869, 20307870, 20307872, 20307873, 20307874, 20307875, 20307876, 20307877, 20307878, 20307879, 20307880, 20307881, 20307882, 20307883, 20307884, 20307885, 20307886, 20307887, 20307888, 20307889, 20307890, 20307891, 20307892, 20307893, 20307894, 20307895, 20307897, 20307898, 20307899, 20307900, 20307901, 20307902, 20307903, 20307904, 20307905, 20307906, 20307907, 20307909, 20307910, 20307911, 20307912, 20307913, 20307914, 20307915, 20307917, 20307918, 20307919, 20307920, 20307921, 20307923, 20307924, 20307926, 20307927, 20307928, 20307929, 20307930, 20307931, 20307932, 20307933, 20307934, 20307935, 20307936, 20307937, 20307938, 20307939, 20307940, 20307941, 20307942, 20307944, 20307945, 20307946, 20307948, 20307949, 20307950, 20307951, 20307952, 20307953, 20307954, 20307955, 20307957, 20307958, 20307959, 20307960, 20307961, 20307962, 20307963, 20307964, 20307965, 20307966, 20307967, 20307968, 20307969, 20307970, 20307971, 20307972, 20307973, 20307974, 20307975, 20307976, 20307977, 20307978, 20307979, 20307980, 20307981, 20307982, 20307983, 20307984, 20307985, 20307986, 20307987, 20307988, 20307990, 20307991, 20307992, 20307993, 20309412, 20309413, 20309414, 20309415, 20309417, 20309418, 20309419, 20309420, 20309421, 20309422, 20309423, 20309424, 20309425, 20309427, 20309428, 20309429, 20309430, 20309432, 20309433, 20309434, 20309435, 20309436, 20309438, 20309439, 20309440, 20309441, 20309442, 20309443, 20309444, 20309445, 20309446, 20309448, 20309449, 20309450, 20309451, 20309452, 20309453, 20309454, 20309455, 20309456, 20309457, 20309458, 20309459, 20309460, 20309461, 20309462, 20309463, 20309464, 20309465, 20309466, 20309467, 20309468, 20309469, 20309470, 20309471, 20309472, 20309473, 20309474, 20309475, 20309476, 20309477, 20309478, 20309479, 20309480, 20309481, 20309482, 20309483, 20309484, 20309485, 20309486, 20309487, 20309488, 20309489, 20309490, 20309491, 20309492, 20309493, 20309494, 20309495, 20309496, 20309497, 20309499, 20309500, 20309501, 20309502, 20309503, 20309504, 20309505, 20309506, 20309507, 20309508, 20309509, 20309510, 20309511, 20309512, 20309513, 20309514, 20309516, 20309517, 20309519, 20309520, 20309521, 20309522, 20309523, 20309524, 20309525, 20309527, 20309528, 20309529, 20309530, 20309531, 20309582, 20309583, 20309584, 20309585, 20309586, 20309587, 20309588, 20309589, 20309590, 20309591, 20309592, 20309593, 20309594, 20309595, 20309596, 20309597, 20309598, 20309599, 20309600, 20309601, 20309752, 20309753, 20309754, 20309755, 20309756, 20309757, 20309758, 20309759, 20309760, 20309761, 20314564, 20314565, 20314566, 20314567, 20314568, 20314569, 20314570, 20314571, 20314572, 20314573, 20314574, 20314575, 20314576, 20314578, 20314579, 20314580, 20314581, 20314582, 20314583, 20314584, 20314585, 20314586, 20314587, 20314588, 20314590, 20314591, 20314592, 20314593, 20314594, 20314595, 20314596, 20314597, 20314598, 20314599, 20314600, 20314601, 20314602, 20314603, 20314604, 20314605, 20314606, 20314607, 20314608, 20314609, 20314610, 20314611, 20314612, 20314613, 20314614, 20314615, 20314616, 20314617, 20314618, 20314619, 20314620, 20314621, 20314622, 20314623, 20314624, 20314625, 20314626, 20314627, 20314628, 20314629, 20314630, 20314631, 20314632, 20314633, 20314634, 20314635, 20314636, 20314637, 20314638, 20314639, 20314640, 20314641, 20314642, 20314643, 20314644, 20314645, 20314646, 20314647, 20314648, 20314649, 20314650, 20314651, 20314653, 20314654, 20314655, 20314656, 20314657, 20314658, 20314659, 20314660, 20314661, 20314662, 20314663, 20314665, 20314666, 20314667, 20314668, 20314669, 20314670, 20314671, 20314672, 20314673, 20314674, 20314675, 20314676, 20314677, 20314678, 20314679, 20314680, 20314681, 20314682, 20314683, 20314684, 20314685, 20314686, 20314687, 20314688, 20314689, 20314690, 20314691, 20314692, 20314693, 20314694, 20314695, 20314696, 20314697, 20314698, 20314699, 20314700, 20314701, 20314702, 20314703, 20326945, 20326946, 20326947, 20326948, 20326949, 20326950, 20326951, 20326952, 20326953, 20326954, 20326955, 20326956, 20326957, 20326958, 20326959, 20326960, 20326961, 20326962, 20326963, 20326964, 20326975, 20326976, 20326977, 20326978, 20326979, 20326980, 20326981, 20326982, 20326983, 20326984, 20326985, 20326986, 20326987, 20326988, 20326989, 20326990, 20326991, 20326992, 20326993, 20326994, 20326995, 20326996, 20326997, 20326998, 20326999, 20327000, 20327001, 20327002, 20327003, 20327004, 20403978, 20403979, 20403980, 20403981, 20309518, 20300942, 20326857, 20265443, 20296538, 20265436, 20226183, 20226187, 20226191, 20226192, 20226193, 20226195, 20226196, 20226197, 20226198, 20226199, 20226200, 20226201, 20226202, 20242038, 20242039, 20242040, 20242041, 20242042, 20242044, 20242045, 20242046, 20254063, 20254064, 20254065, 20254066, 20254067, 20254068, 20254069, 20254070, 20254071, 20254072, 20254083, 20254085, 20254086, 20254087, 20254088, 20254090, 20254091, 20254092, 20254093, 20254094, 20254095, 20254096, 20254097, 20254098, 20254099, 20254100, 20254101, 20254102, 20254103, 20254104, 20254106, 20254107, 20254108, 20254111, 20254112, 20265434, 20265435, 20265437, 20265438, 20265439, 20265440, 20265441, 20265442, 20265444, 20265450, 20265452, 20273202, 20273203, 20273204, 20273205, 20273206, 20273207, 20273208, 20273209, 20273210, 20273211, 20277226, 20277227, 20277228, 20277229, 20277230, 20277231, 20277232, 20277233, 20277234, 20277235, 20277238, 20277240, 20277241, 20277242, 20277245, 20277246, 20277247, 20277248, 20277249, 20277250, 20277251, 20277252, 20277253, 20277254, 20277255, 20277256, 20277257, 20277258, 20277259, 20277260, 20277261, 20277262, 20277263, 20277264, 20277265, 20277266, 20277268, 20277269, 20277273, 20277274, 20285442, 20285443, 20285444, 20285445, 20285447, 20285448, 20285449, 20285451, 20285453, 20285454, 20285455, 20285459, 20285460, 20285504, 20285505, 20285506, 20285507, 20285509, 20285510, 20285511, 20285512, 20285513, 20285549, 20285553, 20285554, 20285556, 20285558, 20285560, 20285561, 20285562, 20285563, 20285565, 20296507, 20296508, 20296509, 20296510, 20296515, 20296516, 20296519, 20296521, 20296522, 20296526, 20296527, 20296528, 20296531, 20296532, 20296533, 20296535, 20297140, 20297141, 20297143, 20297149, 20297151, 20297152, 20297153, 20297154, 20297155, 20297156, 20297157, 20297158, 20297171, 20297182, 20297187, 20300896, 20300898, 20300899, 20300900, 20300901, 20300903, 20300904, 20300905, 20300906, 20300907, 20300910, 20300911, 20300918, 20300922, 20300937, 20300938, 20300941, 20300944, 20307724, 20307725, 20307726, 20307727, 20307728, 20307729, 20307730, 20307731, 20307732, 20307733, 20307744, 20307747, 20307748, 20307752, 20307754, 20307756, 20307758, 20307761, 20307762, 20307763, 20307765, 20307768, 20307769, 20307770, 20307771, 20307773, 20307774, 20307777, 20307779, 20307780, 20307781, 20307782, 20307783, 20307784, 20307785, 20307786, 20307787, 20307788, 20307789, 20307790, 20307791, 20307792, 20307793, 20307794, 20307795, 20307796, 20307797, 20307798, 20307799, 20307800, 20307801, 20307803, 20307804, 20307805, 20307814, 20307815, 20307817, 20307819, 20307820, 20307821, 20307822, 20307823, 20307824, 20307825, 20307826, 20307827, 20307828, 20307829, 20307830, 20307831, 20307832, 20307833, 20307834, 20307835, 20307836, 20307838, 20307842, 20307843, 20326859, 20326861, 20326863, 20326866, 20326871, 20326874, 20326875, 20326880, 20326881, 20326883, 20326884, 20326915, 20326917, 20326919, 20326920, 20326922, 20326923, 20326924, 20326935, 20326936, 20326937, 20326938, 20326939, 20326940, 20326941, 20326942, 20307837, 20307816, 20326916, 20226184, 20226185, 20226186, 20226188, 20226189, 20226190, 20226194, 20242043, 20242047, 20254084, 20254105, 20254109, 20254110, 20265445, 20265446, 20265447, 20265448, 20265449, 20265451, 20265453, 20277236, 20277237, 20277243, 20277244, 20277267, 20277270, 20277271, 20277272, 20285440, 20285441, 20285446, 20285450, 20285452, 20285456, 20285457, 20285508, 20285551, 20285552, 20285555, 20285557, 20285559, 20285564, 20285566, 20285567, 20285568, 20296506, 20296511, 20296512, 20296513, 20296514, 20296517, 20296518, 20296520, 20296523, 20296524, 20296529, 20296530, 20296536, 20296537, 20296539, 20296540, 20296541, 20296543, 20296544, 20296545, 20297139, 20297142, 20297144, 20297145, 20297146, 20297148, 20297150, 20297169, 20297170, 20297172, 20297173, 20297174, 20297175, 20297177, 20297178, 20297179, 20297180, 20297184, 20297185, 20297186, 20300902, 20300908, 20300909, 20300912, 20300913, 20300914, 20300915, 20300916, 20300919, 20300920, 20300921, 20300923, 20300924, 20300925, 20300936, 20300939, 20300940, 20300943, 20307745, 20307746, 20307750, 20307751, 20307757, 20307760, 20307764, 20307766, 20307767, 20307772, 20307775, 20307776, 20307778, 20307806, 20307807, 20307808, 20307809, 20307810, 20307811, 20307812, 20307813, 20307839, 20307840, 20307841, 20326865, 20326867, 20326868, 20326869, 20326870, 20326872, 20326873, 20326876, 20326877, 20326878, 20326879, 20326918, 20326921, 20314704, 20314705, 20314707, 20314710, 20314711, 20314713, 20314706, 20314709, 20314712, 20242028, 20242029, 20242030, 20242031, 20242032, 20242033, 20242034, 20242035, 20242036, 20242037, 20254073, 20254074, 20254075, 20254076, 20254077, 20254078, 20254079, 20254080, 20254081, 20254082, 20254113, 20254114, 20254115, 20254116, 20254117, 20254120, 20254121, 20254122, 20300926, 20300927, 20300928, 20300929, 20300930, 20300931, 20300932, 20300933, 20300934, 20300935, 20307734, 20307736, 20307743, 20254118, 20254119, 20307735, 20307737, 20254089, 20277239, 20296525, 20296534
Other Recalls from Thoratec LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1099-2026 | Class II | CentriMag Blood Pump, REF: 102953, 201-20003, 2... | Oct 10, 2025 |
| Z-0506-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
| Z-0508-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
| Z-0507-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
| Z-0505-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate ... | Oct 9, 2025 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
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.