Medtronic Recalls Extended to More HeartWare Batteries

Medtronic has updated a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12 batteries for ongoing engineering analysis due to a potential weld nonconformance. The company says recent actions have been taken to improve control of the welding process after two letters last year discussed the potential for battery weld nonconformances and provided patient management recommendations.

“A potential weld nonconformance could result in a battery malfunction such that power is no longer provided or the battery is prevented from holding a complete charge, or properly recharging,” a recall letter from Medtronic says. “Battery electrical data from 2019 to present was reviewed, and this review identified batteries that have been distributed with an electrical signature that may be indicative of a weld nonconformance.”