Lower risk Medical device recall · FDA · Published March 30, 2022

Heartware HVAD Controller Model 1407DE Kit: Translation Errors in Displays and Manuals

Heartware recalls HVAD System Controller Model 1407DE Kit due to Finnish and Turkish translation errors in displays and documentation. Affected units have specific serial numbers and GTINs.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1103-2022Medical device Heartware ›

Lower-risk 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.

Take action

Contact the company

Recalling firmHeartware, Inc.14400 Nw 60th Ave · Miami Lakes, FL 33014-2807

✎ GovInfoNow plain-language explainer

Heartware is recalling its HVAD System Controller Model 1407DE Kit because Finnish and Turkish translations in the device displays and manuals contain errors. This could lead to misunderstandings about device operation or emergency procedures for patients using the heart assist system. Read more at govinfonow.com/recall/60870-heartware-hvad-controller-model-1407de-kit-translation-errors-in-displays.

Source Summary by GovInfoNow · govinfonow.com/recall/60870-heartware-hvad-controller-model-1407de-kit-translation-errors-in-displays · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1103-2022

Cite this page

“Heartware HVAD Controller Model 1407DE Kit: Translation Errors in Displays and Manuals.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60870-heartware-hvad-controller-model-1407de-kit-translation-errors-in-displays. Based on FDA recall #Z-1103-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1103-2022%22&limit=1).

The FDA announced on March 30, 2022, that Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit, due to translation errors in Finnish and Turkish. The recall affects 667 units distributed in Finland and Turkey.

How to tell if you have it

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
GTIN 00888707001700
GTIN 00888707002813
GTIN 00888707006941
GTIN 00888707008242

The hazard

The recall cites Finnish and Turkish translation errors in the HVAD controller and monitor displays, as well as in the Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

Context

GovInfoNow's records show Heartware, Inc. has 17 other recalls on record since August 28, 2018. Recent similar recalls include a Heartware HVAD Pump Kit recall for hardened driveline cover risk (November 29, 2022) and updates to controller fault alarms (October 31, 2023). Other recent recalls of similar products include Thoratec HeartMate 3 LVAS Kits Recall for 11 Volt battery failures risk (May 13, 2026), Philips Cardiac Workstation 7000 for inaccurate heart rate data risk (July 1, 2026), and Tand pumps with Czech guide errors (January 30, 2026).

How to tell if you have this one

Check if your HVAD System Controller has serial numbers listed in the provided list (e.g., CON300826, CON315106) or GTINs 00888707001700, 00888707002813, or 00888707006941.

Brand
Heartware
Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Finland and Turkey

Recall number	Product, codes & lots	Quantity
Z-1102-2022	HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104; 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	236 units
Z-1103-2022	HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit; 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	667 units
Z-1104-2022	HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420; 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	510 units
Z-1105-2022	HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0; 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	59 units
Z-1106-2022	HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH; GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764	N/A
Z-1107-2022	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); 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	645 units

Based on the official FDA remedy

What to do — step by step

Check Device Serial Numbers
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.

How this recall unfolded

Recall timeline

FDA published this recall 56 days after the firm started it.

Mar 30, 2022Firm started the recall
May 17, 2022FDA classified it Class II
May 25, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60870-heartware-hvad-controller-model-1407de-kit-translation-errors-in-displays">Heartware HVAD Controller Model 1407DE Kit: Translation Errors in Displays and Manuals (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1103-2022 (March 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1103-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.