06/04/2021
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 HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to patients.
