FDA: Class I recall of Medtronic’s HVAD Pump Implant Kits

Editor's Note

The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious.

The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood throughout the body, while a patient is awaiting a heart transplant.

The recall was issued because the device may fail to initially start, restart, or have a delay in restarting after the pump is stopped. This can cause serious patient harm including heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.

The FDA has received 29 complaints about the device, including 19 serious injuries, 8 life-threatening events, and 2 deaths.

Distribution dates for the devices were October 23, 2017 to April 30, 2020.