Heartware, Inc. Recall 90079
Description: HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Heartware, Inc. Recall 90079 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1103-2022 |
| Event ID | 90079 |
| Event Description | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit |
| Product Type | Devices |
| Distribution | Finland and Turkey |
| Quantity | 667 units |
| Recall Reason | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Device Classification | 20220525 |
| Device Code Info | GTIN 00888707001700, Serial Numbers: CON300826, CON302649, CON304346, CON305438, CON305669, CON309302, CON309306, CON309974, CON312894, CON313111, CON313129, CON313154, CON314788, CON314789, CON314903, CON314929, CON315066, CON315120, CON315384, CON300826, CON304248, CON304346, CON304363, CON304943, CON300612, CON300622, CON302530, CON302655, CON302814, CON303005, CON303057, CON303093, CON303132, CON303368, CON303549, CON303571, CON303936, CON304027, CON304028, CON304282, CON304302, CON304318, CON304322, CON304327, CON304328, CON304358, CON304360, CON304362, CON304381, CON304451, CON304453, CON304587, CON304596, CON304600, CON304610, CON304614, CON304620, CON304628, CON304645, CON304649, CON304793, CON304797, CON304889, CON304965, CON305110, CON305123, CON305124, CON305142, CON305146, CON305148, CON305150, CON305277, CON305282, CON305325, CON315244, CON314763, CON315247, CON314577, CON313809, CON314057, CON315260, CON315259, CON315246, CON314770, CON314120, CON314193, CON314339, CON314021, CON314211, CON314068, CON313626, CON310360, CON314188, CON314084, CON314016, CON314085, CON314027, CON314346, CON314087, CON313967, CON314024, CON314187, CON313993, CON311103, CON314148, CON313513, CON313068, CON313452, CON312745, CON313489, CON312959, CON312899, CON313164, CON312896, CON313107, CON313161, CON313166, CON312898, CON313162, CON313232, CON312948, CON312897, CON313109, CON313183, CON313187, CON313168, CON312900, CON313095, CON313165, CON310155, CON309602, CON309853, CON309850, CON310096, CON310090, CON310102, CON306178, CON310793, CON310499, CON310103, CON310101, CON310500, CON306822, CON310192, CON310100, CON310094, CON306705, CON307902, CON307900, CON304639, CON307903, CON307818, CON304646, CON304658, CON304638, CON307997, CON307367, CON307999, CON307959, CON307960, CON307975, CON308006, CON307998, CON307770, CON307868, CON308144, CON308001, CON307172, CON307166, CON307315, CON306727, CON307536, CON307404, CON307123, CON307571, CON307436, CON307167, CON307435, CON307401, CON306728, CON307132, CON306949, CON305644, CON305822, CON305774, CON305770, CON305651, CON305773, CON305419, CON305554, CON305555, CON305424 GTIN 00888707002813, Serial Numbers: CON315106, CON315108, CON315743, CON315791, CON315792, CON315831, CON316010, CON316450, CON316462, CON316826, CON317363, CON317371, CON317718, CON318002, CON318004, CON318364, CON318751, CON318856, CON318864, CON318994, CON319035, CON319523, CON319524, CON319648, CON400331, CON400332, CON400634, CON400636, CON400637, CON400651, CON401103, CON401111, CON401188, CON401251, CON401264, CON401265, CON401825, CON402006, CON402065, CON402077, CON402302, CON402304, CON402658, CON402659, CON402973, CON402974, CON403346, CON403351, CON403543, CON403546, CON403803, CON403804, CON403883, CON403892, CON403980, CON403986, CON404058, CON405273, CON405274, CON405687, CON405706, CON405707, CON406419, CON406420, CON406490, CON406586, CON406610, CON406634, CON406635, CON406666, CON406717, CON406718, CON406719, CON406720, CON406740, CON406867, CON406869, CON406872, CON406874, CON406875, CON406880, CON407000, CON407001, CON407003, CON407004, CON407008, CON407009, CON407012, CON407015, CON407016, CON407017, CON407018, CON407019, CON407020, CON407021, CON407097, CON407113, CON407115, CON407177, CON407178, CON407179, CON407180, CON407207, CON407208, CON407235, CON407270, CON407487, CON407504, CON407519, CON407537, CON407572, CON407587, CON407685, CON407745, CON407780, CON407790, CON407845, CON407898, CON407911, CON407915, CON407917, CON407918, CON407945, CON407946, CON407947, CON407961, CON407998, CON407999, CON408000, CON408005, CON408031, CON408033, CON408038, CON408039, CON408043, CON408047, CON408048, CON408053, CON408055, CON408056, CON408066, CON408067, CON408068, CON408069, CON408070, CON408072, CON408074, CON408075, CON408076, CON408079, CON408090, CON408107, CON408112, CON408118, CON408122, CON408126, CON408127, CON408133, CON408144, CON408166, CON408168, CON408169, CON408186, CON408194, CON408199, CON408219, CON408230, CON408290, CON408300, CON408301, CON408305, CON408306, CON408307, CON408350, CON408351, CON408363, CON408370, CON408371, CON408372, CON408373, CON408381, CON408382, CON408384, CON408387, CON408388, CON408391, CON408397, CON408398, CON408399, CON408406, CON408407, CON408408, CON408411, CON408431, CON408442, CON408496, CON408497, CON408498, CON408502, CON408503, CON408517, CON408518, CON408519, CON408520, CON408521, CON408522, CON408523, CON408531, CON408533, CON408540, CON409013, CON409100, CON409102, CON409106, CON409109, CON409111, CON409112, CON409115, CON409120, CON409135, CON409138, CON409139, CON409140, CON409145, CON409146, CON409152, CON409153, CON409157, CON409174, CON409175, CON409179, CON409180, CON409183, CON409191, CON409195, CON409196, CON409199, CON409206, CON409212, CON409243, CON409244, CON409266, CON409267, CON409268, CON409328, CON409330, CON409334, CON409336, CON409378, CON409386, CON409387, CON409396, CON409403, CON409406, CON409409, CON409422, CON409430, CON409433, CON409439, CON409452, CON409454, CON409470, CON409476, CON409482, CON409486, CON409487, CON409488, CON409593, CON409672, CON409774, CON409873, CON409877, CON409878, CON409879, CON409880, CON409883, CON409974, CON409975, CON409980, CON409981, CON410954, CON410955, CON410960, CON410962, CON410965, CON410966, CON410967, CON410969, CON410970, CON410991, CON410992, CON410993, CON410996, CON411015, CON411046, CON411047, CON411063, CON411097, CON411098, CON411102, CON411110, CON411112, CON411140, CON411143, CON411144, CON411145, CON411212, CON411213, CON411215, CON411218, CON411220, CON411221 GTIN 00888707006941, Serial Numbers: CON410823, CON410843, CON410844, CON410941, CON410980, CON410982, CON411051, CON411053, CON411058, CON411061, CON411085, CON411088, CON411099, CON411103, CON411104, CON411225, CON411235, CON411236, CON411254, CON411283, CON411334, CON411336, CON411337, CON411610, CON411644 GTIN 00888707008242, Serial Numbers: CON412460, CON412713, CON412766, CON412769, CON412770, CON412771, CON412772, CON412773, CON412798, CON412802, CON412803, CON412806, CON412807, CON412808, CON412815, CON412852, CON412853, CON412854, CON412855, CON412887, CON412888, CON412890, CON412891, CON412892, CON412893, CON412898, CON412902, CON412908, CON412920, CON412925, CON412927, CON412928, CON412932, CON412938, CON412940, CON412944, CON412951, CON412954, CON412956, CON412958, CON412961, CON412962, CON412970, CON413026, CON413131, CON413135, CON413228, CON413229, CON413235, CON413239, CON413240, CON413242, CON413285, CON413291, CON413292, CON413293, CON413301, CON413316, CON413335, CON413341, CON413342, CON413344, CON413391, CON413392, CON413410, CON413428, CON413431, CON413434, CON413451, CON413454, CON413480, CON413541, CON413546, CON413550, CON413552, CON413556, CON413557, CON413569, CON413579, CON413580, CON413632, CON413651, CON413652, CON413653, CON413654, CON413658, CON413667, CON413680, CON413681, CON413682, CON413686, CON413696, CON413697, CON413700, CON413701, CON413702, CON413703, CON413704, CON413705, CON413706, CON413707, CON413708, CON413720, CON413721, CON413737, CON413738, CON413739, CON413747, CON413748, CON413749, CON413751, CON413752, CON413753, CON413758, CON413776, CON413792, CON413793, CON413807, CON413869, CON413870, CON414339, CON414340, CON415019, CON415020, CON415021, CON415040, CON415041, CON415042, CON415046, CON415047, CON415048, CON415050, CON415051, CON415052, CON415053, CON415067, CON415068, CON415087, CON415106, CON415135, CON415137, CON415141, CON415142, CON415143, CON415146, CON415148, CON415835, CON415781 |
| Center Classification Date | 20220517 |
| Recall Initiation Date | 20220330 |
| Recalling Firm | Heartware, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |