Recall Z-1512-2022— Heartware, Inc.
Class I · Ongoing
Class I FDA medical device recall by Heartware, Inc., initiated 2022-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE. Reason: 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-06-28
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.