FDA: Class I recall of HeartMate 3TM Left Ventricular Assist System

Editor's Note

The Food and Drug Administration on May 22 identified the recall by Abbott of all lots of its HeartMate 3^TM Left Ventricular Assist System as Class I, the most serious.

The recall was issued because of a malfunction in the device’s outflow graft assembly that may cause the graft to twist and close up over time. Occlusion of the graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump flow can lead to serious adverse events and death.

Distribution dates are September 2, 2014, to present.