The FDA has announced that Medtronic is recalling its HeartWare Ventricular Assist Device (HVAD) pump implant kit, a part of the HeartWare HVAD system. This is a Class I recall, which means using the device can lead to serious injury or death.
The announcement comes after the FDA received numerous complaints that pump implant kits “may fail to initially start, restart, or have a delay in restarting after the pump was stopped.” There have been 29 complaints so far, including reports of 19 serious injuries and two deaths.
“These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations,” the FDA explained. “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.”
This recall includes kits labeled as PUMP 1103, PUMP 1004 or PUMP 1104JP. Lots impacted by the recall include 8721869-001-01, 8722375-001-01 and 8722375-002-02. All kits were distributed from Oct. 23, 2017, to April 30, 2020.
Medtronic first reached out to affected customers back in December 2020, including specific instructions for both healthcare providers and patients.
The full FDA announcement is available here.