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

FDA Device Recall #Z-1103-2022 — Class II — March 30, 2022

Recall Summary

Recall Number Z-1103-2022
Classification Class II — Moderate risk
Date Initiated March 30, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Heartware, Inc.
Location Miami Lakes, FL
Product Type Devices
Quantity 667 units

Product Description

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

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 Pattern

Finland and Turkey

Lot / 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

Other Recalls from Heartware, Inc.

Recall # Classification Product Date
Z-0478-2024 Class II PUMP 1103 HVAD (HeartWare Ventricular Assist De... Oct 31, 2023
Z-0482-2024 Class II HVAD (HeartWare Ventricular Assist Device) STER... Oct 31, 2023
Z-0481-2024 Class II PUMP 1104 HVAD (HeartWare Ventricular Assist De... Oct 31, 2023
Z-0479-2024 Class II PUMP 1104 HVAD (HeartWare Ventricular Assist De... Oct 31, 2023
Z-0475-2024 Class II HVAD (HeartWare Ventricular Assist Device) STER... Oct 31, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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