Power loss risks prompt FDA Class 1 recall designation for heart pump accessories

Editor's Note

Sudden, unexpected shutdown and restart prompted the US Food and Drug Administration (FDA) to designate a class 1 recall—the most severe category reserved for serious risk of injury or death—for Abbot’s HeartMate Mobile Power Unit, which powers system controllers for the HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II LVAS.  

As detailed in FDA’s April 24 announcement, users should seek immediate replacement of MPU devices that have experienced power issues. Replacement of devices not experiencing power issues will begin no later than June. Any device experiencing power issues should not be used. Patients should be immediately switched to 14V rechargeable batteries within 15 minutes, at which time backup power will deplete and the unit will stop. Patients also should be sent the patient letter provided by Abbott.

Read the full announcement for additional details, including listed serial numbers, contact information, and instructions for both providers and users. At the time of the announcement, no injuries or deaths had been reported.