HeartWare HVAD System Batteries Recalled for Critical Electrical Faults
HeartWare HVAD System Batteries are being recalled due to electrical faults that may prevent the battery from powering the device controller, accepting charges, or maintaining charge. Approximately 19,616 batteries distributed worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The defects affect a critical life-support device and prevent it from functioning. Although no deaths or injuries are reported in the source text, the potential impact on a life-support device justifies the severe rating.
Plain-English summary
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE, are being recalled due to battery electrical faults. The affected batteries may be unable to power the device controller, unable to accept charge from the battery charger, and/or may appear charged while actually discharging.
Approximately 19,616 batteries are affected and have been distributed worldwide to consumers in the United States, Japan, and numerous other countries across Europe, Asia, Australia, and the Middle East.
The electrical faults create a risk that the device will not function properly, potentially leaving patients without power to their ventricular assist device. The FDA classified this as a Class I recall due to the serious nature of these defects.
The recalled product
- Product
- HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
- Manufacturer
- Heartware, Inc.
- Affected units
- 19,616
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a. GTIN 00763000187767
- Serial Numbers: BAT941874
- BAT941880
- BAT941886
- BAT941935
- BAT941937
- BAT941944
- BAT941948
- BAT941960
- BAT942348
- BAT941747
- BAT941897
- BAT941955
- BAT941959
- BAT937852
- BAT937853
- BAT937887
- BAT937889
- BAT937893
- BAT941119
Distribution
Distributed nationwide across the United States.
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