FDAJanuary 7, 2016device
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
What to do
FDA enforcement status: Terminated
Brands named
heartware
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN2023-10-31
- FDAPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 11042023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 12052023-10-31
- FDAPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 11032023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 11002023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 11022023-10-31
- FDASTERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 11012023-10-31
- FDAPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP2023-10-31
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