FDA Class 1 recall: Medtronic HVAD Pump Implant Kit due to delayed or failed restart

March 2, 2021

Medtronic is recalling the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit for the HeartWare HVAD System because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped, reported the U.S. Food and Drug Administration (FDA) in medical device Class I recall, the most serious type of recall as use of these devices may cause serious injuries or death.

The 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 HVAD system is used to help the heart continue to pump blood to the rest of the body and 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.

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.

On Dec. 18, 2020, Medtronic sent an Urgent Medical Device Communication Letter to all affected customers and on Dec. 23, 2020, Medtronic sent an Urgent Medical Device Communication Letter to all accounts who have previously purchased a Medtronic HVAD Pump. The notice instructed customers to:

Advise health care providers and staff the following points from the current Instructions for Use (IFU) to avoid unnecessary pump stops:

· Do not disconnect the driveline from the controller.

· Do not disconnect both power sources (batteries and AC or DC adapter) from the controller at the same time; one external power source should always remain connected to the controller.

· Do not exchange the controller unless explicitly directed by a High Priority alarm condition or by a VAD team member.

· Reinforce the proper response to a [Controller Fault] alarm and [Electrical Fault] alarm. These are Medium Priority alarms unrelated to an immediate pump stop. These alarms will result in the word [Call] in the Controller Display, notifying the patient to call their clinician.

· Reinforce making good connections of power sources and the data cable in the controller ports.

· Inform patients implanted with one of these identified pumps to contact their Ventricular Assist Device coordinator prior to any controller exchange, and to coordinate performing an exchange of controllers in a clinical setting.

FDA has the recall.