Class I Recall for Medtronic’s HeartWare HVAD System

The US Food and Drug Administration (FDA) has classified a recent field action undertaken by Medtronic for their HeartWare HVAD system as a Class I recall.

Last month, Medtronic issued an alert to physicians that warned about a potential interruption of the electrical connection between the HeartWare HVAD power source and HVAD controller. The problem is caused by oxidation of connecting surfaces and results in the system switching to its secondary power source.

“Interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop,” according to the FDA. “A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death.”

The unintended switching to a secondary power source can also result in unexpected “beeping,” which occurs when the electrical connection interruption resolves. This may “confuse the patient or caregiver, as the controller may display sufficient battery capacity of AC/DC connectivity at the time of the audible tone,” according to Medtronic.

More than 204,000 devices are affected by the recall, which includes products manufactured and distributed between March 2006 and May 2018.

In a May 2018 letter to physicians, Medtronic said the projected rate of unexpected power source switching over a 2-year period on a per-patient basis is approximately 25%. The per-patient probability of serious adverse events caused by the issue is 0.003%.  

The HVAD system, which is indicated as a bridge to heart transplantation in patients at risk of death from end-stage left ventricular heart failure, is designed for in-hospital and out-of-hospital settings. It is also indicated as destination therapy for patients where cardiac transplantation is not planned.