Medtronic Heartware Ventricular Assist Device System - Recall Due to Risk of Neurological Adverse Events, Mortality and Delay or Failure to Restart

On June 3, 2021, the Medtronic HVAD TM System was recalled due to an increase in neurological adverse events and mortality, as well as a potential for the internal pump of the Medtronic HVAD TM System to delay or fail to restart. Medtronic is now communicating additional instructions as a follow-up to a Recall Notice posted on June 9, 2021.

Medical devices - Product safety