The Food and Drug Administration (FDA) has announced a recall of specific lots of the Medtronic HVAD pump implant kits due to a possible delay or failure to start.

The HeartWare Ventricular Assist Device (HVAD) pump implant kit is part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned.

Medtronic is recalling the HVAD pump implant kit because the device 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. 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 FDA has identified this as a Class I recall, the most serious type of recall, as use of the device may result in serious injury or death. There have been 29 complaints about this device issue, which include 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.

Food and Drug Administration (FDA). Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped [news release]. March 1, 2021. Available at: click here. Accessed March 1, 2021.