Home » Medtronic Updates HeartWare Ventricular Assist Device Battery Recall
Medtronic Updates HeartWare Ventricular Assist Device Battery Recall
Devices Regulatory Affairs
Medtronic has updated its May and June 2022 HeartWare Ventricular Assist Device (HVAD) battery recall, providing serial numbers for affected batteries.
The batteries were initially recalled in May 2022 with the FDA deeming the recall as Class 1 in June 2022 because of the risk of serious injury or death if the batteries caused the device to fail.
The affected batteries have a potential weld defect, Medtronic said, which could lead to the battery no longer providing power, properly recharging or holding a complete charge, possibly triggering various alarms.
The recall is the seventh for the HeartWare device in the past year. Medtronic stopped selling the product in June 2021.