FDAJune 28, 2022device
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
What to do
FDA enforcement status: Ongoing
Brands named
heartware
UPCs
0076300018776700888707005692
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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