Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart

Date:  08/12/2021

Product type:  Medical Device

Recalled Product

  • HeartWare HVAD System
  • Model Numbers: See Full List of Affected Devices
  • Distribution Dates: August 30, 2016 to June 3, 2021
  • Devices Recalled in the U.S.: 4,620
  • Date Initiated by Firm: June 3, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-stops-distribution-and-sale-heartware-hvad-system-due-risk-neurological-adverse-events