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Abbott recalls HeartMate 3 Left Ventricular Assist System

Posted on May 22, 2018 by Medtech[y] Staff


The FDA has issued a Class I Recall for Abbott's HeartMate 3 due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time.

On May 21, 2018, Abbott sent an Urgent Medical Device Recall notification to physicians, alerting them again to the device malfunction and providing them with instructions for managing patients getting the device or patients who already have the device implanted.

Patients experiencing a persistent low flow alarm should contact the physician managing their HeartMate 3™ Left Ventricular Assist System immediately. Abbott is recommending not to remove the device because of this issue. 

4,878 HeartMate devices are being recalled nationwide. 

The HeartMate 3™ Left Ventricular Assist System helps deliver blood from the heart to the rest of the body. It is used for short-term support of patients who are at risk of death from end-stage left ventricular heart failure, such as patients awaiting a heart transplant. The system includes a blood pump that is implanted in the space around the heart (pericardium) along with an outflow graft that connects the pump to the aorta.