The company recalled its HVAD pump implant kits, part of the HeartWare HVAD system, which is used to help the heart continue to pump blood to the rest of the body. It’s often used as a bridge to cardiac transplants in patients at risk of death from heart failure, the FDA said.
Medtronic is recalling the pump implant kit because the device may fail to start, restart or have a delay in restarting after the pump is stopped. The issue has occurred during preimplant testing, during implantation and after implantation, according to the FDA.
If the device fails to start or restart, it could cause heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.
Medtronic has received 29 complaints about the issue, including 19 serious injuries, eight cases of patients who had a life-threatening event but recovered without long-term effects, and two patient deaths.
Read the full FDA news release here.
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