FDA: Class I recall of Medtronic HVAD Pump Implant Kit

Editor's Note

The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants.

The Kit was recalled because of a pump weld defect that may cause the pump to rotate incorrectly. If this occurs, it may lead to pump malfunction, death, severe injury, or major surgery to replace the pump.

To date, there have been 3 complaints, 1 death, and 2 injuries. Distribution dates were October 11, 2006, to June 3, 2021.