Heartware, Inc. HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Brand
Heartware, Inc.
Lot Codes / Batch Numbers
GTIN 00888707000598, Serial Numbers: HW28827 GTIN 00888707001649, Serial Numbers: HW29474, HW29864, HW29985, HW30222, HW31506, HW31511, HW32021, HW32255, HW32301, HW34343, HW35068, HW35085, HW35290, HW35311, HW35349, HW35559, HW35657, HW35662, HW35664 GTIN 00888707002424, Serial Numbers: HW29480, HW29696, HW30650, HW30766, HW30767, HW31698, HW31851 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707006323, Serial Numbers: HW34982, HW35722, HW36082, HW36189, HW36297, HW36375, HW36452, HW36539, HW36605, HW36649, HW36687, HW36740, HW36798, HW36865, HW37202 GTIN 00888707005951, Serial Numbers: HW35887, HW35893 GTIN 00888707006347, Serial Numbers: HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623, HW36808, HW36809, HW36810, HW36918, HW36946, HW36948, HW36949, HW36950, HW36951, HW36952, HW36953, HW36954, HW36955, HW36956, HW36959, HW36960, HW36961, HW36962, HW36963, HW37006, HW37007, HW37008, HW37009, HW37010, HW37154, HW37155, HW37156, HW37157, HW37161, HW37162, HW37164, HW37165, HW37166, HW37168, HW37169, HW37263, HW37358, HW37378, HW37381, HW37386, HW37387, HW37432, HW37434, HW37440, HW37447 GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990 GTIN 00888707002486, Serial Numbers: HW30860, HW30835, HW30807, HW30817, HW30861, hw30795, hw30800, HW30663, hw30794, HW30662, hw30793, HW30664, hw30799, HW30516, hw30798, HW30514, HW30522, HW30518, HW30517, HW30391, HW30361, HW30401, HW30362, HW30396, HW30405, HW30395, HW30389, HW30394, HW30359, HW30141, HW30142, HW30140, HW30135, HW30143, HW30136, HW30144, HW30139, HW30137, HW29759, HW29762, HW29758, HW29765, HW29760, HW29757, HW29770, HW29771, HW29768, HW29769, HW29795, HW29747, HW29752, HW29734, HW29750, HW29749, HW29746, HW29748, HW29025, HW29432, HW29442, HW29446, HW29344, HW29482
Products Sold
GTIN 00888707000598, Serial Numbers: HW28827 GTIN 00888707001649, Serial Numbers: HW29474, HW29864, HW29985, HW30222, HW31506, HW31511, HW32021, HW32255, HW32301, HW34343, HW35068, HW35085, HW35290, HW35311, HW35349, HW35559, HW35657, HW35662, HW35664 GTIN 00888707002424, Serial Numbers: HW29480, HW29696, HW30650, HW30766, HW30767, HW31698, HW31851 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707006323, Serial Numbers: HW34982, HW35722, HW36082, HW36189, HW36297, HW36375, HW36452, HW36539, HW36605, HW36649, HW36687, HW36740, HW36798, HW36865, HW37202 GTIN 00888707005951, Serial Numbers: HW35887, HW35893 GTIN 00888707006347, Serial Numbers: HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623, HW36808, HW36809, HW36810, HW36918, HW36946, HW36948, HW36949, HW36950, HW36951, HW36952, HW36953, HW36954, HW36955, HW36956, HW36959, HW36960, HW36961, HW36962, HW36963, HW37006, HW37007, HW37008, HW37009, HW37010, HW37154, HW37155, HW37156, HW37157, HW37161, HW37162, HW37164, HW37165, HW37166, HW37168, HW37169, HW37263, HW37358, HW37378, HW37381, HW37386, HW37387, HW37432, HW37434, HW37440, HW37447 GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990 GTIN 00888707002486, Serial Numbers: HW30860, HW30835, HW30807, HW30817, HW30861, hw30795, hw30800, HW30663, hw30794, HW30662, hw30793, HW30664, hw30799, HW30516, hw30798, HW30514, HW30522, HW30518, HW30517, HW30391, HW30361, HW30401, HW30362, HW30396, HW30405, HW30395, HW30389, HW30394, HW30359, HW30141, HW30142, HW30140, HW30135, HW30143, HW30136, HW30144, HW30139, HW30137, HW29759, HW29762, HW29758, HW29765, HW29760, HW29757, HW29770, HW29771, HW29768, HW29769, HW29795, HW29747, HW29752, HW29734, HW29750, HW29749, HW29746, HW29748, HW29025, HW29432, HW29442, HW29446, HW29344, HW29482
Heartware, Inc. is recalling HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 due to Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responde. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026