Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller

Hazard / Issue

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.

Issued by

FDA

Distribution: Finland and Turkey

Lot/Code Info: 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