The FDA has identified this as a Class I recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc., the recall is due to welding defects that allow separation of the two cell battery packs used to power the system. The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging. As a result, the battery may fail suddenly. If this malfunction occurs, it will trigger a Power Disconnect alarm on the controller screen and in the Alarm Log tab of the HVAD Monitor while the affected battery is still connected to the controller.

Health care providers with questions about this recall should contact their local Medtronic Representative.
Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday-Friday, 8 a.m. to 5 p.m. Central time).