FDA: Class I Recall for HeartWare VAD Pump Implant Kit
Devices may fail to start or restart after stoppage, or only restart after a delay, putting patients at risk of MI, heart failure, or death.
The US Food and Drug Administration is alerting physicians about a heart pump recall initiated late last year: Medtronic issued a recall for its HeartWare ventricular assist device (VAD) pump implant kit back in December 2020. Today, the FDA categorized this action as a Class I recall, its most serious type, meaning that use could cause serious injuries or death.
Medtronic says the HeartWare pump implant kit, which is part of the HeartWare VAD system, may fail to initially start or to restart, or may only restart with a delay after the pump is stopped. The company has received 29 complaints about the issue, including 19 serious injuries and eight cases of patients who had a life-threatening event but recovered without long-term damage. Two patients, however, have died.
“These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of postimplant situations,” the FDA recall notice explains. “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.”
The recall is believed to affect a total of 157 devices in the United States.
On December 23, 2020, Medtronic sent an urgent device communication to anyone who had previously purchased the HeartWare device, instructing customers to avoid unnecessary pump stops and providing a range of recommendations (available here).
Patients implanted with affected devices should be informed of the issue and, in consultation with their physician, decide whether controller exchange is required. Specific lot and model numbers affected are provided in the recall, which covers devices distributed between October 23, 2017, and April 30, 2020.
The complex device, which is approved for patients with end-stage left ventricular heart failure as a bridge-to-transplantation and as a destination therapy for patients in whom transplant is not planned, has been subject to a range of recalls in the past. Most recently, Medtronic issued an unrelated recall concerning pump outflow graft tears and strain relief screw fracture that can occur during assembly but which may not become evident until after implantation.