Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
FDA Device Recall #Z-2056-2020 — Class I — April 3, 2020
Recall Summary
| Recall Number | Z-2056-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | April 3, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Heartware, Inc. |
| Location | Miami Lakes, FL |
| Product Type | Devices |
| Quantity | 2225 Units |
Product Description
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Reason for Recall
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Distribution Pattern
Worldwide Distribution
Lot / Code Information
GTIN 00888707002028, Serial Numbers: HW28848, hw29011, HW29154, HW29211, HW29248, HW29249, HW29273, HW29329, HW29426, HW29465, HW29472, HW29522, HW29534, HW29548, HW29549, HW29567, HW29588, HW29593, HW29602, HW29612, HW29667, HW29700, HW29786, HW29815, HW29915, HW29928, HW29949, HW30039, HW30082, HW30083, HW30150, HW30153, HW30208, HW30211, HW30226, HW30320, HW30342, HW30358, HW30360, HW30363, HW30378, HW30380, HW30382, HW30390, HW30398, HW30400, HW30402, HW30406, HW30410, HW30430, HW30475, HW30484, HW30494, HW30498, HW30595, HW30596, HW30597, HW30601, HW30604, HW30651, HW30768, HW30769, HW30770, HW30771, HW30814, HW30821, HW30829, HW30863, HW30865, HW30867, HW30871, HW30953, HW30961, HW30962, HW30966, HW30971, HW30972, HW30974, HW31020, HW31076, HW31101, HW31103, HW31104, HW31107, HW31113, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31232, HW31235, HW31242, HW31244, HW31249, HW31254, HW31255, HW31260, HW31261, HW31262, HW31267, HW31383, HW31387, HW31388, HW31399, HW31409, HW31410, HW31411, HW31412, HW31414, hw31445, HW31446, hw31447, hw31448, hw31449, hw31451, HW31452, hw31453, hw31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32474, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35127, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35142, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731 GTIN 00888707002387, Serial Numbers: HW28851, HW29783, HW29793, HW29794, HW29827, HW29870, HW29918, HW30045, HW30046, HW30505, HW30765, HW30842, HW30844, HW30845, HW30846, hw30978, HW31075, HW31077, HW31080, hw31089, hw31091, HW31095, HW31161, HW31342, HW31348, HW31555, HW31556, HW31557, HW31683, HW31860, HW31903, HW31920, HW31924, HW31926, HW32026, HW32027, HW32028, HW32149, HW32153, HW32163, HW32282, HW32513, HW32514, HW32562, HW32563, HW34004, HW34006, HW34091, HW34092, HW34125, HW34272, HW34273, HW34274, HW34349, HW34350, HW34351, HW34352, HW34357, HW34358, HW34359, HW34366, HW34374, HW34436, HW34953, HW34968, HW35080, HW35144, HW35145, HW35148, HW35327, HW35342, HW35344, HW35537, HW35596, HW35603, HW35604, HW35605, HW35606, HW35607, HW35713, HW35714, HW35717, HW35718, HW35721, HW35723 GTIN 00888707001649, Serial Numbers: HW29132, HW29232, hw29653, HW29682, HW29684, HW29705, HW29864, HW29985, HW29991, HW30096, HW30100, HW30145, HW30146, HW30373, HW30374, HW30421, HW30525, HW30529, HW30726, HW30738, HW30836, HW30840, HW30862, HW30939, hw30949, hw30950, HW31048, HW31071, HW31082, HW31088, hw31133, hw31394, HW31415, HW31417, HW31420, HW31421, HW31423, hw31483, hw31505, hw31506, hw31507, hw31510, HW31511, hw31512, hw31513, hw31515, hw31516, hw31517, HW31546, HW31551, HW31554, HW31566, HW31587, HW31588, HW31589, HW31590, HW31592, HW31632, HW31639, HW31685, HW31795, HW31801, HW31806, HW31808, HW31809, HW31811, HW31812, HW31813, HW31815, HW31891, HW31892, HW31893, HW31919, HW31921, HW31973, HW31982, HW31985, HW32000, HW32001, HW32014, HW32015, HW32018, HW32021, HW32022, HW32024, HW32042, HW32050, HW32055, HW32056, HW32064, HW32081, HW32094, HW32112, HW32123, HW32138, HW32147, HW32186, HW32245, HW32255, HW32264, HW32265, HW32268, HW32270, HW32301, HW32394, HW32410, HW32420, HW32558, HW32559, HW32560, HW32561, HW34029, HW34031, HW34093, HW34094, HW34132, HW34148, HW34180, HW34266, HW34268, HW34269, HW34270, HW34271, HW34296, HW34301, HW34324, HW34327, HW34340, HW34341, HW34343, HW34345, HW34346, HW34348, HW34418, HW34420, HW34431, HW34507, HW34508, HW34641, HW34692, HW34745, HW34764, HW34836, HW34906, HW34932, HW34936, HW34940, HW34941, HW34963, HW34977, HW34992, HW34994, HW35019, HW35021, HW35033, HW35035, HW35038, HW35041, HW35065, HW35068, HW35085, HW35090, HW35094, HW35114, HW35147, HW35157, HW35196, HW35197, HW35210, HW35237, HW35250, HW35290, HW35308, HW35309, HW35310, HW35311, HW35312, HW35313, HW35314, HW35315, HW35318, HW35320, HW35328, HW35329, HW35330, HW35333, HW35338, HW35349, HW35365, HW35366, HW35368, HW35370, HW35371, HW35372, HW35373, HW35375, HW35378, HW35402, HW35404, HW35405, HW35408, HW35409, HW35411, HW35412, HW35418, HW35421, HW35423, HW35465, HW35470, HW35475, HW35476, HW35485, HW35486, HW35546, HW35547, HW35550, HW35551, HW35552, HW35553, HW35554, HW35555, HW35556, HW35557, HW35558, HW35559, HW35560, HW35564, HW35598, HW35599, HW35602, HW35640, HW35657, HW35658, HW35659, HW35662, HW35663, HW35664, HW35665, HW35666, HW35667, HW35672, HW35694, HW35719, HW35750, HW35753, HW36121, HW36154, HW36165, HW36168 GTIN 00888707000581, Serial Numbers: HW29203, HW29425, HW29427, HW29428, HW29430, HW29439, HW29517, HW29679, HW29680, HW30589, HW30638, HW30706, HW30876, HW31144, HW31187, hw31376, hw31380, HW31442, HW31727, HW31998, HW32023, HW32416, HW34017 GTIN 00888707002417, Serial Numbers: HW29478, HW30381, HW30831, HW34380, HW34421, HW35348, HW35613, HW35756, HW35761, HW35763 GTIN 00888707002493, Serial Numbers: HW29483, HW29697, HW29698, hw31178, HW31520, HW31821, HW31823, HW31827, HW32086, HW32242, HW32246, HW32518, HW32519, HW34021, HW34365, HW34367, HW34792, HW34915, HW35155, HW35158, HW35252, HW35343, HW35345, HW35346, HW35350, HW35400, HW35401, HW35529, HW35530, HW35574, HW35591, HW35660, HW35661, HW35785 GTIN 00888707002400, Serial Numbers: HW29518, HW29693, HW30092, HW32257, HW34012, HW34210, HW35034, HW35154, HW35573, HW35653 GTIN 00888707002547, Serial Numbers: HW29561, HW29601, HW29931, HW30502, HW30593, HW30619, HW30632, HW30783, HW30796, HW30819, HW30826, HW31136, HW31140, HW31141, HW31156, HW31157, HW31158, HW31382, HW31393, HW31406, HW31408, HW31413, HW31416, HW31426, HW31429, HW31553, HW31791, HW31937, HW31994, HW32118, HW32269, HW32309, HW32336, HW32347, HW32373, HW32385, HW32522, HW32523, HW32524, HW32554, HW32557, HW34003, HW34007, HW34008, HW34049, HW34050, HW34053, HW34054, HW34382, HW34383, HW34513, HW34514, HW34516, HW34517, HW34518, HW35251, HW35275 GTIN 00888707000680, Serial Numbers: HW29571, HW29578, HW29845, HW30635, HW30639, HW30711, HW31150 GTIN 00888707002394, Serial Numbers: HW30469, HW30506, HW30508, HW30509, HW30510, HW30511, HW30512, HW30655, HW31580, HW31582, HW31583, HW31584, HW31992, HW31993, HW32200, HW32207, HW32217, HW32238, HW32239, HW32240, HW32515, HW32517, HW34022, HW34023, HW34395, HW34461, HW34557, HW34561, HW34582, HW34751, HW34950, HW34955, HW34991, HW34996, HW35016, HW35149, HW35150, HW35186, HW35336, HW35386, HW35397, HW35484, HW35509, HW35510, HW35538, HW35566, HW35609, HW35610, HW35611, HW35648, HW35649, HW35651, HW35679, HW35699, HW35700, HW35706, HW35776, HW35779 GTIN 00888707000239, Serial Numbers: HW30634, HW30645, HW30877, HW34737 GTIN 00888707002530, Serial Numbers: HW30797, HW31108, HW31440, HW31828, HW31928, HW32182, HW32253, HW32263, HW34559, HW35000, HW35162, HW35532, HW35533, HW35590 GTIN 00888707002523, Serial Numbers: HW30859, HW31703, HW31704, HW31859, HW32030, HW32036, HW32040, HW32102, HW32520, HW32521, HW34018, HW34020, HW34027, HW34028, HW34986, HW35040, HW35043, HW35049, HW35216, HW35217, HW35218, HW35490, HW35531, HW35619, HW35786 GTIN 00888707002431, Serial Numbers: hw30979, hw31123, HW32029, HW32180, HW34024, HW34381, HW34615, HW35119, HW35733 GTIN 00888707002585, Serial Numbers: hw31079, hw31081, hw31168, hw31170, HW35095, HW35164, HW35351, HW35353, HW35355, HW35496, HW35497, HW35575, HW35576 GTIN 00888707002516, Serial Numbers: hw31147, hw31162, HW32507, HW34524, HW35474 GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36007, HW36008, HW36009, HW36010, HW36013, HW36014, HW36015, HW36018, HW36019, HW36020, HW36021, HW36067, HW36068, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36182, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36196, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36249, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36306, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36337, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36420, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36558, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36632, HW36633, HW36636, HW36637, HW36655, HW36659, HW36660, HW36662, HW36663, HW36664, HW36669, HW36670, HW36671, HW36672, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36853, HW36854, HW36855, HW36898, HW36899, HW36900, HW36903, HW36919, HW36921 GTIN 00888707002486, Serial Numbers: HW31444, HW31569, HW31673, HW31814, HW31817, HW31818, HW31820, HW31824, HW31825, HW31826, HW31872, HW31873, HW31875, HW31877, HW31927, HW31932, HW31934, HW31939, HW31940, HW31941, HW31995, HW31996, HW31997, HW31999, HW32002, HW32008, HW32009, HW32010, HW32011, HW32013, HW32032, HW32034, HW32038, HW32046, HW32053, HW32057, HW32062, HW32065, HW32071, HW32085, HW32109, HW32165, HW32166, HW32195, HW32205, HW32211, HW32221, HW32236, HW32243, HW32250, HW32506, HW34015, HW34122, HW34123, HW34124, HW34251, HW34252, HW34275, HW34277, HW34280, HW34354, HW34355, HW34356, HW34361, HW34364, HW34433, HW34434, HW34437, HW34439, HW34440, HW34442, HW34443, HW34444, HW34452, HW34454, HW34619, HW34620, HW34621, HW34622, HW34623, HW34624, HW34629, HW34630, HW34631, HW34636, HW34656, HW34719, HW34738, HW34739, HW34742, HW34748, HW34749, HW34750, HW34753, HW34757, HW34758, HW34761, HW34762, HW34767, HW34769, HW34779, HW34818, HW34853, HW34867, HW34873, HW34879, HW34880, HW34882, HW34885, HW34888, HW34890, HW34897, HW34898, HW34900, HW34905, HW34909, HW34911, HW34912, HW34945, HW34954, HW34960, HW35171, HW35228, HW35230, HW35278, HW35282, HW35283, HW35297, HW35298, HW35300, HW35303, HW35304, HW35306, HW35307, HW35512, HW35513, HW35514, HW35516, HW35517, HW35518, HW35519, HW35520, HW35521, HW35522, HW35523, HW35525, HW35526, HW35527, HW35528, HW35565, HW35567, HW35568, HW35569, HW35570, HW35593, HW35600, HW35612, HW35614, HW35615, HW35616, HW35617, HW35618, HW35645, HW35650, HW35652, HW35685, HW35725, HW35734, HW35737, HW35738, HW35740, HW35742, HW35743, HW35744, HW35745, HW35746, HW35747, HW35748, HW35751, HW35752, HW35760, HW35762, HW35765 GTIN 00888707002462, Serial Numbers: HW31586, HW31700, HW32035 GTIN 00888707002424, Serial Numbers: HW31698, HW31851 GTIN 00888707002448, Serial Numbers: HW31779, HW31780, HW32546, HW34095, HW34617, HW35398, HW35511, HW35589, HW35597 GTIN 00888707002455, Serial Numbers: HW31852, HW31856, HW32025, HW32198, HW34026, HW34637, HW35544 GTIN 00888707006019, Serial Numbers: HW31983, HW34720, HW34974, HW35376, HW35377, HW35849, HW35866, HW35869, HW35871, HW35873, HW35877, HW35878, HW35879, HW35880, HW35998, HW36000, HW36056, HW36057, HW36058, HW36059, HW36060, HW36061, HW36062, HW36063, HW36113, HW36114, HW36115, HW36116, HW36117, HW36118, HW36119, HW36120, HW36145, HW36146, HW36155, HW36156, HW36157, HW36158, HW36159, HW36167, HW36221, HW36222, HW36223, HW36350, HW36351, HW36352 GTIN 00888707006408, Serial Numbers: HW34292, HW35932, HW36083, HW36084, HW36087, HW36129, HW36130, HW36171, HW36172, HW36173, HW36212, HW36247, HW36250, HW36261, HW36263, HW36264, HW36265, HW36266, HW36348, HW36349, HW36413, HW36414, HW36415, HW36416, HW36594, HW36638 GTIN 00888707002554, Serial Numbers: HW34337, HW34362, HW34484, HW34591, HW34594, HW34625, HW34682, HW34693, HW34732, HW34833, HW34838, HW34846, HW34876, HW34884, HW34889, HW35052, HW35057, HW35061, HW35067, HW35316, HW35323, HW35359, HW35362, HW35363, HW35364, HW35458, HW35536, HW35585, HW35620, HW35622, HW35623, HW35709, HW35710, HW35728, HW35732, HW35758, HW35759, HW35764, HW35767, HW35771, HW35772, HW35775, HW35777, HW35780, HW35782 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707002141, Serial Numbers: HW34848, HW34849, HW35711 GTIN 00888707006323, Serial Numbers: HW34982, HW35031, HW35379, HW35380, HW35381, HW35382, HW35383, HW35384, HW35388, HW35389, HW35390, HW35391, HW35392, HW35621, HW35642, HW35654, HW35712, HW35722, HW35727, HW35729, HW35736, HW35755, HW35770, HW35781, HW35783, HW35977, HW36024, HW36025, HW36027, HW36028, HW36029, HW36030, HW36032, HW36033, HW36034, HW36042, HW36043, HW36044, HW36045, HW36046, HW36064, HW36065, HW36072, HW36073, HW36074, HW36075, HW36076, HW36077, HW36078, HW36079, HW36080, HW36081, HW36082, HW36123, HW36124, HW36125, HW36126, HW36127, HW36128, HW36133, HW36134, HW36135, HW36136, HW36137, HW36139, HW36140, HW36141, HW36142, HW36143, HW36144, HW36147, HW36148, HW36149, HW36150, HW36151, HW36152, HW36153, HW36187, HW36188, HW36189, HW36190, HW36191, HW36202, HW36203, HW36204, HW36206, HW36207, HW36208, HW36209, HW36210, HW36234, HW36235, HW36236, HW36237, HW36238, HW36239, HW36242, HW36244, HW36245, HW36267, HW36268, HW36271, HW36272, HW36274, HW36275, HW36284, HW36286, HW36290, HW36291, HW36292, HW36293, HW36295, HW36296, HW36297, HW36339, HW36340, HW36342, HW36343, HW36344, HW36346, HW36364, HW36366, HW36367, HW36375, HW36378, HW36379, HW36380, HW36439, HW36440, HW36441, HW36443, HW36444, HW36445, HW36446, HW36450, HW36451, HW36452, HW36453, HW36454, HW36455, HW36456, HW36520, HW36521, HW36522, HW36524, HW36528, HW36529, HW36532, HW36533, HW36534, HW36535, HW36537, HW36539, HW36548, HW36549, HW36550, HW36551, HW36552, HW36604, HW36605, HW36606, HW36607, HW36608, HW36639, HW36640, HW36641, HW36645, HW36649, HW36651, HW36661, HW36674, HW36675, HW36676, HW36687, HW36714, HW36729, HW36731, HW36732, HW36733, HW36734, HW36735, HW36737, HW36738, HW36739, HW36744, HW36908, HW36909, HW36922, HW36923, HW36925, HW36932 GTIN 00888707005951, Serial Numbers: HW35279, HW35331, HW35503, HW35524, HW35581, HW35675, HW35715, HW35720, HW35739, HW35768, HW35787, HW35788, HW35789, HW35790, HW35791, HW35792, HW35793, HW35794, HW35795, HW35796, HW35797, HW35798, HW35799, HW35821, HW35822, HW35823, HW35824, HW35825, HW35826, HW35827, HW35831, HW35833, HW35834, HW35835, HW35836, HW35837, HW35838, HW35839, HW35840, HW35841, HW35842, HW35843, HW35844, HW35845, HW35846, HW35883, HW35887, HW35888, HW35889, HW35890, HW35891, HW35892, HW35893, HW35894, HW35895, HW35896, HW35897, HW35898, HW35900, HW35905, HW35906, HW35907, HW35921, HW35925, HW35926, HW35928, HW35930, HW35933, HW35934, HW35945, HW35946, HW35947, HW35948, HW35949, HW35950, HW35951, HW35952, HW35953, HW35954, HW35955, HW35956, HW35957, HW35959, HW35960, HW35961 GTIN 00888707002264, Serial Numbers: HW35741, HW35773 GTIN 00888707006316, Serial Numbers: HW35754, HW35774, HW35865, HW35868, HW35874, HW35940, HW35958, HW35962, HW35963, HW35964, HW35965 GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35819, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35973, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997 GTIN 00888707006309, Serial Numbers: HW35876, HW35882, HW35884, HW35885, HW35886, HW35941, HW35942, HW35999 GTIN 00888707006347, Serial Numbers: HW35902, HW35903, HW35908, HW35909, HW35910, HW35911, HW35912, HW35913, HW35914, HW35915, HW35918, HW35920, HW36001, HW36002, HW36003, HW36016, HW36035, HW36036, HW36037, HW36038, HW36039, HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623 GTIN 00888707006446, Serial Numbers: HW35979, HW35980, HW35982, HW35984, HW36160, HW36161, HW36162, HW36163, HW36164, HW36278, HW36287, HW36381, HW36382, HW36383, HW36384, HW36385, HW36386, HW36387, HW36388, HW36460, HW36462, HW36464, HW36465, HW36469, HW36470, HW36471, HW36472, HW36480, HW36481, HW36482, HW36483, HW36484, HW36486, HW36487, HW36489, HW36491, HW36492, HW36494, HW36495 GTIN 00888707006392, Serial Numbers: HW35986, HW35987, HW36066, HW36085, HW36086, HW36213, HW36214, HW36215, HW36216, HW36217, HW36218, HW36219, HW36220, HW36289, HW36311, HW36417, HW36418, HW36517, HW36587, HW36588, HW36589, HW36590, HW36652, HW36656, HW36860 GTIN 00888707007290, Serial Numbers: HW36421, HW36422 GTIN 00888707006354, Serial Numbers: HW36838, HW36880 No GTIN, Serial Numbers: HW26099, HW26126, HW26330, HW26660, HW26939, HW26940, HW27099, HW27452, HW27678, HW28063, HW28199, HW28373, HW28418, HW28895, HW28973, HW29073, HW29214, HW29298, HW29318, HW29351, HW29353, HW29354, HW29359
Other Recalls from Heartware, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0478-2024 | Class II | PUMP 1103 HVAD (HeartWare Ventricular Assist De... | Oct 31, 2023 |
| Z-0482-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STER... | Oct 31, 2023 |
| Z-0481-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist De... | Oct 31, 2023 |
| Z-0479-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist De... | Oct 31, 2023 |
| Z-0475-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STER... | Oct 31, 2023 |
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.