HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- Company
- Heartware, Inc.
- Recall Initiated
- March 30, 2022
- Recall Number
- Z-1104-2022
- Quantity
- 510 units
- Firm Location
- Miami Lakes, FL
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.
Distribution
Finland and Turkey
Lot / Code Info
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
Root Cause
Labeling design
Action Taken
Starting 30-Mar-2022, Medtronic initiated an Urgent Medical Device Notice to VAD Coordinators at customer sites by regional mail and visit in order to inform them of the errors and the corrections impacting the incorrect translation in Finland and Turkey for the HVAD" System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual.