Reported May 25, 2022 · Ongoing
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
- Lot codes and dates
- GTIN 00888707000598
- Serial NumbersHW28827 GTIN 00888707001649
- Serial Numbers
HW29474HW29864HW29985HW30222HW31506HW31511HW32021HW32255HW32301HW34343HW35068HW35085HW35290HW35311HW35349HW35559HW35657HW35662HW35664 GTIN 00888707002424
- Serial Numbers
HW29480HW29696HW30650HW30766HW30767HW31698HW31851 GTIN 00888707004558
- Serial Numbers
HW34759HW34785HW35655HW35656 GTIN 00888707006323
- Serial Numbers
HW34982HW35722HW36082HW36189HW36297HW36375HW36452HW36539HW36605HW36649HW36687HW36740HW36798HW36865HW37202 GTIN 00888707005951
- Serial Numbers
HW35887HW35893 GTIN 00888707006347
- Serial Numbers
110 of 110 codes
HW36040HW36048HW36049HW36050HW36051HW36052HW36053HW36054HW36055HW36088HW36089HW36092HW36093HW36094HW36095HW36096HW36097HW36100HW36101HW36102HW36103HW36105HW36106HW36107HW36108HW36109HW36110HW36111HW36112HW36170HW36540HW36541HW36542HW36543HW36544HW36565HW36566HW36568HW36569HW36570HW36571HW36572HW36573HW36574HW36575HW36576HW36577HW36578HW36579HW36581HW36582HW36583HW36584HW36585HW36586HW36611HW36612HW36615HW36616HW36618
- Serial Numbers
HW41915HW41916HW41918HW41919HW41945HW41946HW41947HW41948HW41978HW41979HW41981HW41982HW41983HW41984HW41988HW41990 GTIN 00888707002486
- Serial Numbers
62 of 62 codes
HW30860HW30835HW30807HW30817HW30861hw30795hw30800HW30663hw30794HW30662hw30793HW30664hw30799HW30516hw30798HW30514HW30522HW30518HW30517HW30391HW30361HW30401HW30362HW30396HW30405HW30395HW30389HW30394HW30359HW30141HW30142HW30140HW30135HW30143HW30136HW30144HW30139HW30137HW29759HW29762HW29758HW29765HW29760HW29757HW29770HW29771HW29768HW29769HW29795HW29747HW29752HW29734HW29750HW29749HW29746HW29748HW29025HW29432HW29442HW29446
- Amount recalled
- 236 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Heartware, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.