In December 2020 and May 2021, Medtronic informed a limited group of physicians that a subset of their patients may experience a delay to restart or failure to restart at a higher rate than the overall population of patients with the HeartWare™ Ventricular Assist Device (HVAD™) System.

Over the past year, Medtronic has continued to track and analyze device performance related to this issue, and we now have additional information about which of the devices in this subset may have higher failure rates than others. We have contacted the clinicians whose patients have the affected devices to provide this updated information so together they can make the most informed treatment decisions.

We have provided communications materials for physicians to use in reaching out to their patients, and we are sending a letter directly to the U.S. patients most affected by this issue.

There are no new HVAD devices identified as part of this updated communication.

We’re committed to helping patients with the HVAD System achieve the best possible outcomes. We encourage patients with the HVAD Systems to speak with their physicians about individualized treatment decisions. Patients and their care teams may also visit our patient website (https://www.medtronic.com/us-en/patients/treatments-therapies/ventricular-assist-device.html) or contact Medtronic directly through a dedicated hotline at (1-800-635-3930).

Contact: Kathleen Janasz, CRM