The Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System because:
There is an increased risk of neurological adverse events and mortality associated with the internal pump.
There is a potential for the internal pump to stop. If the internal pump stops, it may delay restarting or fail to restart.
Both problems may lead to death or serious injuries. Health care providers should stop new implants of the Medtronic HVAD pump, and should continue to manage care of patients with a previously implanted Medtronic HVAD System according to the instructions in the Medtronic Urgent Medical Device Communication Notification letter.
Food and Drug Administration (FDA). Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers. June 3, 2021. Available at: click here. Accessed June 3, 2021.