Z-1102-2022 Class II Ongoing
FDA device recall Z-1102-2022 was initiated by Heartware, Inc. on Mar 30, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 236 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Mar 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 units
Product Description
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1102-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026