Reported Dec 28, 2022 · Ongoing
HeartWare HVAD Pump Kit, REF 1104
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 HVAD Pump Kit, REF 1104
- Lot codes and dates
- UDI/DI 00888707006323
- Serial Numbers
3,584 of 3,584 codes
HW25347HW26099HW26126HW26274HW26281HW26330HW26332HW26660HW26762HW26939HW26940HW26969HW27069HW27099HW27154HW27184HW27596HW27674HW27678HW27679HW27682HW27711HW27730HW27781HW27849HW27859HW27900HW27910HW27988HW27990HW27996HW28025HW28036HW28037HW28041HW28047HW28063HW28079HW28152HW28160HW28169HW28170HW28176HW28177HW28199HW28210HW28222HW28232HW28336HW28339HW28349HW28354HW28373HW28374HW28375HW28418HW28446HW28477HW28544HW28548
- Amount recalled
- 10320 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
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.