HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

[Posted 06/01/2018]

AUDIENCE: Cardiology, Risk Manager, Nursing, Patient

ISSUE: Medtronic is recalling the HeartWare HVAD because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. This interruption to the electrical connection, which occurs when the power source is still physically connected, is caused by oxidation on the connecting surfaces between the power source connector and the controller’s power source socket. Interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop. 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.

A full list of affected devices is available in the FDA recalls database.

BACKGROUND: The HeartWare Ventricular Assist System (HVAD) is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from end-stage left ventricular heart failure. It functions as a pump that helps the heart deliver blood to the rest of the body. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter. These indications have been expanded to include HVAD use for myocardial recovery, or as destination therapy in patients for whom subsequent transplantation is not planned.

RECOMMENDATION: Medtronic sent a letter advising hospitals and physicians to:

Reinforce the importance of always ensuring two power sources are connected at all times
Reinforce best practice guidance for managing power sources when going to sleep and awakening
Instruct patients to report any persistent, unexpected audible tones to the VAD team for additional instructions. In addition, FDA reminds patients to call 911 if they are experiencing a medical emergency.

FDA also reminds patients whenever possible to have a trained caregiver nearby when changing power sources and/or controllers. For additional information about this recall, you may contact Medtronic Customer Service at 877-367-4823.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/01/2018 - Recall Notice - FDA]