HeartMate 3 Problem With Outflow Graft Twisting Called Class I Recall by FDA

A field correction has been implemented for the HeartMate 3 left ventricular assist system (Abbott) due to the potential for twisting of the device’s outflow graft connecting the pump to the aorta. The US Food and Drug Administration (FDA) has deemed the action a class I recall. Abbott, however, is not actually removing any devices from patients or hospitals.

Twisting of the outflow graft can result in occlusion, which “can reduce or stop pump flow and set off a persistent low flow alarm in the system,” according to an FDA recall notice. “A reduction in pump can lead to serious adverse events such as blood clots and death.”

In an initial alert about this issue on April 5, Abbott said that it had received 32 reports of twisting of the outflow graft, resulting in a rate of 0.72% among the 4,467 devices implanted worldwide at that time (there are now 4,878 units across the United States included in the recall). Those reports included instances of low blood flow and clotting, as well as three deaths. The company followed up that advisory by implementing a field corrective action on May 4.

On Monday, Abbott sent an Urgent Medical Device Recall notification to physicians to remind them about the issue and provide instructions for managing patients who will get the device or who have already been implanted. The manufacturer recommends performing a CT angiogram to identify outflow graft twisting if a persistent low flow alarm is detected. If surgical repair is needed, “the Outflow Graft Bend Relief should be reattached in its original state or repaired to prevent bending, abrasion or occlusion of the outflow graft at the graft’s attachment point to the pump.”

HeartMate 3 is currently approved in the United States for short-term hemodynamic support in patients with end-stage LV heart failure.