Recall archive / FDA device enforcement

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 — FDA record Z-1104-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 30, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
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.
Classification: Class II
Recalling firm: Heartware, Inc.
Quantity: 510 units
Agency-reported status: Ongoing
Source record identifier: Z-1104-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Label field

Details supplied by the agency

Lot, code or applicability

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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Finland and Turkey

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: May 25, 2022
Recall initiation date: Mar 30, 2022
Center classification date: May 17, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records