Heartware Ventricular Assist System – Heartware Battery

Medtronic is informing customers of product performance issues related to the Heartware Ventricular Assist Device (HVAD) system batteries. Medtronic is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified within some batteries that can cause the battery to fail to deliver power, 2) an interaction between the battery software configuration and the battery circuit board can cause electrical faults within some batteries. Manufacturer is taking action to improve battery performance and address quality issues. this notification provides information on the two battery performance issues as well as patient management recommendations. In both situations, it is important that patients respond to all battery related alarms. if both batteries connected to an HVAD controller malfunction, a pump stop event could occur due to controller loss of power. a malfunction of a single battery that is connected to the HVAD controller will cause the controller to rely solely on the second power source to power the pump. No batteries are being requested to be returned or exchanged as part of this communication.

Recall start date: June 28, 2022