Today the FDA has announced a Class I recall of Medtronic’s HVAD pump implant kits due to a product delay or failure that can result in serious patient harm. The kit, which is part of the HeartWare ventricular assist device (HVAD), may fail to initially start, restart or have a delay in restarting after the pump was stopped. “These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations,” according to the FDA website. “If the device has delays or fails to start or restart, this could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.”
Thus far there have been 29 complaints related to the device problem, including 19 serious injuries, 8 life-threatening events, and two deaths.
The HVAD pump implant kits were distributed between October 23, 2017 and April 30, 2020. A total of 157 devices have been recalled in the United States.