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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Heartware, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1103-2022

Related Recalls

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Oct 31, 2023 Implants & Prosthetics View Details →