HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

Heartware notified customers on about 01/23/2020 via "Urgent Field Safety Notice" letter. Customers were notified of the potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. When this occurs, communication circuits between the battery and the Controller may be damaged. If circuit damage occurs, it will be necessary to exchange the Controller to restore communication between the batteries and Controller. Instructions included to advise patients to carefully follow the guidance provided in the patient manual related to connecting a power source. Pay attention when connecting and disconnecting power supply cables to ensure users verify the correct cable is being connected to their Controller. Patients were instructed to report any persistent, unexpected audible tones to their Clinician for additional instructions. Additional instructions included to ensure all personnel within your organization or any customers if further distributed are notified of this recall. If you have any questions, please contact the Cardiac and Vascular Group Customer Focused Quality at 763-526-2513 or by email to: [email protected].