Federal regulators have announced a class I recall for the Medtronic HeartWare HVAD cardiac device, indicating that it may stop working, posing a risk of serious injury or death for patients.
The Medtronic HeartWare HVAD recall impacts more than 16,000 devices that have been implanted as of May 22. Although no deaths have yet been reported in connection with the recall, the FDA categorized the issues as the most serious type of medical device recall.
The action was taken after Medtronic discovered the electrical connection between the system’s power source, such as the battery, AC adapter, or DC adapter, and the HVAD controller could be interrupted. This may cause the pump to stop working, resulting in an exacerbation of heart failure symptoms, including weakness, dizziness, anxiety, nausea, loss of consciousness or death.
The Medtronic HeartWare HVAD is used as a bridge to cardiac transplant for patients at risk of left ventricular heart failure. It is used as a pump to help the heart deliver blood to the rest of the body while the patient awaits transplant. It is used on patients in the hospital and out of the hospital, such as when a patient is being transported via aircraft or helicopter.
Electrical connection interruption can occur because of oxidation on the connecting surfaces between the power source connector and the controller’s power source socket. The interruption can occur when the power source is still physically connected.
This isn’t the first time Medtronic has been plagued by recalls of its devices. Medtronic issued a recall for HVAD System Controllers in May 2017, which was also categorized as a class I recall and was issued after the HVAD devices began experiencing battery failure, power and data failures, and premature wearing of the alignment guides. That recall resulted in at least two deaths, four serous injuries and 27 field reports of other failures and problems regarding the devices.
A recent government report warned that failed and recalled heart devices, like the HVAD system, have cost Medicare $1.5 million over ten years.
Concerning the most recent recall, Medtronic issued letters advising hospitals and doctors of certain steps to take. Those steps include focusing on the importance of ensuring two power sources are connected at all times, reinforcing best practice guidance to patients for managing power sources when going to sleep and awakening, instructing patients to report unexpected audible tones, and calling 911 if they experience an emergency.
Patients should always try to have a trained caregiver nearby when attempting to change the power source.
All side effects and adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting Program.