A recall of implant kits for the HeartWare Ventricular Assist Device (HVAD), initiated by Medtronic in November 2020, has been declared Class I by the US Food and Drug Administration, the agency announced today.
Medtronic issued the recall, which covers 157 devices distributed from October 2017 through April 2020, because of the potential for the pumps to fail to start initially, to fail to restart, or to delay restarting after the pump has been stopped, the announcement says.
"These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations," it states. They have been associated with 29 complaints about the issue, involving "19 serious injuries and 8 cases of patients who had a life-threatening event but recovered without long term effects. Two deaths have been reported."
The recall covers implant kits for three models of the HVAD pumps, from three manufacturing lots. Medtronic sent Urgent Medical Device Communication letters to patients and providers with affected HVAD systems in late December 2020. The letters included instructions on how to determine whether a device controller exchange is necessary and the safety measures to follow in the interim.
It follows a Class 1 recall, initiated by Medtronic and announced in May 2020, of pump outflow grafts and outflow graft strain relief components of the HVAD that had been associated with 92 complaints and four deaths.
Cite this: FDA: Recall of Medtronic HVAD Implant Kits Is Class 1 - Medscape - Mar 01, 2021.