Recall of ventricular assist device implant kit designated Class I
The FDA has identified Medtronic’s recall of its ventricular assist device implant kit as Class I recall, the most serious type, due to risk for serious injuries or death.
The recalled device (HeartWare Ventricular Assist Device Pump Implant, Medtronic) may fail to initially start, restart or delay restarting after the pump was stopped. According to a safety alert issued by the FDA, delays or failures to start or restart occurred during preimplant testing, during the implant or in a variety of post-implant situations and may result in heart attack, worsening HF, additional procedures, hospitalizations or death.
According to the alert, there were 29 complaints regarding this device, of which 19 reported serious injuries; eight patients experienced a life-threatening event but recovered without long term effects; and two patients died.
On Dec. 18, 2020, Medtronic sent an urgent communication letter to all affected customers. On Dec. 23, 2020, Medtronic sent urgent letters to all accounts who have previously purchased the ventricular assist device implant kit.