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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90079

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 30, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Heartware, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

Z-1102-2022
Recall number
Z-1102-2022
Initiated
March 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
236 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

GTIN 00888707000598, Serial Numbers: HW28827 GTIN 00888707001649, Serial Numbers: HW29474, HW29864, HW29985, HW30222, HW31506, HW31511, HW32021, HW32255, HW32301, HW34343, HW35068, HW35085, HW35290, HW35311, HW35349, HW35559, HW35657, HW35662, HW35664 GTIN 00888707002424, Serial Numbers: HW29480, HW29696, HW30650, HW30766, HW30767, HW31698, HW31851 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707006323, Serial Numbers: HW34982, HW35722, HW36082, HW36189, HW36297, HW36375, HW36452, HW36539, HW36605, HW36649, HW36687, HW36740, HW36798, HW36865, HW37202 GTIN 00888707005951, Serial Numbers: HW35887, HW35893 GTIN 00888707006347, Serial Numbers: 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, HW36808, HW36809, HW36810, HW36918, HW36946, HW36948, HW36949, HW36950, HW36951, HW36952, HW36953, HW36954, HW36955, HW36956, HW36959, HW36960, HW36961, HW36962, HW36963, HW37006, HW37007, HW37008, HW37009, HW37010, HW37154, HW37155, HW37156, HW37157, HW37161, HW37162, HW37164, HW37165, HW37166, HW37168, HW37169, HW37263, HW37358, HW37378, HW37381, HW37386, HW37387, HW37432, HW37434, HW37440, HW37447 GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990 GTIN 00888707002486, Serial Numbers: HW30860, HW30835, HW30807, HW30817, HW30861, hw30795, hw30800, HW30663, hw30794, HW30662, hw30793, HW30664, hw30799, HW30516, hw30798, HW30514, HW30522, HW30518, HW30517, HW30391, HW30361, HW30401, HW30362, HW30396, HW30405, HW30395, HW30389, HW30394, HW30359, HW30141, HW30142, HW30140, HW30135, HW30143, HW30136, HW30144, HW30139, HW30137, HW29759, HW29762, HW29758, HW29765, HW29760, HW29757, HW29770, HW29771, HW29768, HW29769, HW29795, HW29747, HW29752, HW29734, HW29750, HW29749, HW29746, HW29748, HW29025, HW29432, HW29442, HW29446, HW29344, HW29482

Distribution pattern

Finland and Turkey

device · product 2 of 6

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit

Z-1103-2022
Recall number
Z-1103-2022
Initiated
March 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
667 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

Finland and Turkey

device · product 3 of 6

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

Z-1104-2022
Recall number
Z-1104-2022
Initiated
March 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
510 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

GTIN 00888707000420, Serial Numbers: CON301559, CON301671, CON301680, CON301691, CON301692, CON301699, CON301714, CON301828, CON302225, CON302283, CON302286, CON302325, CON303175, CON303662, CON303733, CON303773, CON304089, CON304110, CON304225, CON304349, CON300543, CON300552, CON300553, CON300556, CON300619, CON300621, CON300623, CON300628, CON300638, CON300902, CON301367, CON301375, CON301485, CON301625, CON301674, CON301708, CON301870, CON301935, CON301943, CON301978, CON301996, CON302001, CON302013, CON302049, CON302113, CON302127, CON302138, CON302142, CON302143, CON302162, CON302165, CON302169, CON302172, CON302177, CON302180, CON302182, CON302183, CON302199, CON302227, CON302250, CON302262, CON302268, CON302281, CON302285, CON302299, CON302322, CON302327, CON302331, CON302336, CON302349, CON302366, CON302369, CON302371, CON302373, CON302374, CON302375, CON302387, CON302391, CON302394, CON302397, CON302399, CON302408, CON302412, CON302415, CON302420, CON302423, CON302436, CON302441, CON302443, CON302445, CON302446, CON302450, CON302451, CON302456, CON302458, CON302460, CON302465, CON302470, CON302471, CON302472, CON302474, CON302491, CON302496, CON302505, CON302508, CON302510, CON302511, CON302515, CON302522, CON302525, CON302535, CON302538, CON302539, CON302540, CON302543, CON302544, CON302546, CON302555, CON302556, CON302557, CON302560, CON302561, CON302562, CON302566, CON302567, CON302577, CON302581, CON302584, CON302595, CON302601, CON302613, CON302614, CON302619, CON302621, CON302623, CON302629, CON302664, CON302666, CON302667, CON302671, CON302673, CON302679, CON302698, CON302699, CON302706, CON302709, CON302710, CON302712, CON302716, CON302721, CON302722, CON302723, CON302724, CON302725, CON302727, CON302730, CON302745, CON302751, CON302752, CON302753, CON302759, CON302765, CON302770, CON302775, CON302776, CON302783, CON302785, CON302787, CON302801, CON302809, CON302815, CON302817, CON302822, CON302827, CON302834, CON302838, CON302840, CON302846, CON302847, CON302850, CON302852, CON302856, CON302858, CON302861, CON302864, CON302865, CON302866, CON302875, CON302876, CON302877, CON302884, CON302885, CON302887, CON302897, CON302898, CON302899, CON302906, CON302908, CON302911, CON302912, CON302921, CON302925, CON302929, CON302930, CON302932, CON302939, CON302942, CON302945, CON302949, CON302950, CON302958, CON302959, CON302961, CON302963, CON302964, CON302967, CON302971, CON302981, CON303001, CON303038, CON303039, CON303040, CON303041, CON303049, CON303051, CON303055, CON303063, CON303080, CON303088, CON303098, CON303100, CON303113, CON303119, CON303134, CON303142, CON303143, CON303148, CON303150, CON303152, CON303153, CON303154, CON303183, CON303213, CON303242, CON303259, CON303266, CON303280, CON303288, CON303328, CON303332, CON303339, CON303373, CON303382, CON303389, CON303397, CON303410, CON303456, CON303468, CON303551, CON303552, CON303565, CON303577, CON303593, CON303600, CON303601, CON303604, CON303606, CON303610, CON303614, CON303619, CON303623, CON303626, CON303635, CON303673, CON303716, CON303727, CON303729, CON303732, CON303738, CON303746, CON303778, CON303780, CON303822, CON303831, CON303833, CON303907, CON303913, CON303914, CON303916, CON303953, CON303959, CON303965, CON303983, CON303988, CON303989, CON304085, CON304093, CON304098, CON304107, CON304116, CON304117, CON304124, CON304132, CON304133, CON304134, CON304138, CON304164, CON304170, CON304186, CON304190, CON304191, CON304194, CON304204, CON304206, CON304207, CON304208, CON304209, CON304210, CON304212, CON304213, CON304214, CON304215, CON304217, CON304218, CON304222, CON304228, CON304229, CON304255, CON304259, CON304272, CON304274, CON304275, CON304281, CON304284, CON304287, CON304294, CON304296, CON304298, CON304321, CON304326, CON304330, CON304335, CON304388, CON304408, CON304411, CON304417, CON304419, CON304427, CON304440, CON304515, CON304531, CON304540, CON304542, CON304544, CON304545, CON304546, CON304547, CON304552, CON304573, CON304595, CON304603, CON304607, CON304612, CON304616, CON304617, CON304629, CON304633, CON304644, CON304648, CON304650, CON304667, CON304668, CON304673, CON304680, CON304685, CON304695, CON304697, CON304699, CON304708, CON304713, CON304723, CON304730, CON304741, CON304742, CON304743, CON304746, CON304747, CON304748, CON304749, CON304751, CON304752, CON304760, CON304775, CON304786, CON304787, CON304805, CON304810, CON304821, CON304822, CON304826, CON304829, CON304832, CON304835, CON304839, CON304840, CON304849, CON304852, CON304856, CON304857, CON304863, CON304870, CON304883, CON304884, CON304888, CON304892, CON304893, CON304894, CON304895, CON304898, CON304900, CON304903, CON304922, CON304930, CON304931, CON304932, CON304963, CON304964, CON304966, CON304970, CON304971, CON304973, CON304975, CON304976, CON304977, CON304979, CON304980, CON304982, CON304984, CON304985, CON304990, CON304992, CON305001, CON305003, CON305004, CON305010, CON305014, CON305015, CON305016, CON305018, CON305021, CON305025, CON305026, CON305028, CON305030, CON305031, CON305033, CON305034, CON305035, CON305036, CON305038, CON305039, CON305042, CON305043, CON305044, CON305045, CON305047, CON305049, CON305050, CON305055, CON305057, CON305059, CON305063, CON305070, CON305072, CON305075, CON305078, CON305080, CON305085, CON305091, CON305093, CON305094, CON305096, CON305102, CON305122, CON305125, CON305126, CON305127, CON305133, CON305134, CON305135, CON305137, CON305138, CON305140, CON305149, CON305179, CON305190, CON305211, CON305226, CON305232, CON305233, CON305234, CON305238, CON305239, CON305241, CON305243, CON305244, CON305248, CON305250, CON305367, CON305400

Distribution pattern

Finland and Turkey

device · product 4 of 6

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

Z-1105-2022
Recall number
Z-1105-2022
Initiated
March 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

GTIN 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872

Distribution pattern

Finland and Turkey

device · product 5 of 6

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

Z-1106-2022
Recall number
Z-1106-2022
Initiated
March 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764

Distribution pattern

Finland and Turkey

device · product 6 of 6

HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish)

Z-1107-2022
Recall number
Z-1107-2022
Initiated
March 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Heartware, Inc.
Quantity
645 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

No GTIN HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R025893 HVAD System Instructions For Use (FI), Lot Number: R020771 HVAD System Instructions For Use (FI), Lot Number: R020771 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R020769 HVAD System Patient Manual (FI-Finnish), Lot Number: R021391 HVAD System Patient Manual (FI-Finnish), Lot Number: R021391 HVAD System Patient Manual (FI-Finnish), Lot Number: R022265 HVAD System Instructions For Use - FI, Lot Number: R025606 HVAD System Instructions For Use (FI), Lot Number: R028504 HVAD System OUS Patient Manual (FI-Finnish), Lot Number: R028100 HVAD System Emergency Responder Guide (TR-Turkish), Lot Number: R025877 HVAD System Patient Manual (TR-Turkish), Lot Number: R021248 HVAD System Patient Manual (TR-Turkish), Lot Number: R021248 HVAD System Patient Manual (TR-Turkish), Lot Number: R027179 HVAD System Patient Manual (TR-Turkish), Lot Number: R027179 HVAD System OUS Instructions For Use (TR-Turkish), Lot Number: R025760R01

Distribution pattern

Finland and Turkey

Field note

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