The FDA issued a Class I recall for Abbott’s HeartMate 3 left ventricular assist device due to possible twisting of the outflow graft that could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood flow or clotting that could lead to serious injury or death.
The regulatory agency recommends that patients experiencing a persistent low-flow alarm should contact the physician managing their HeartMate 3 device immediately. The company, which began contacting physicians earlier this month, said it was aware of 32 reports of outflow graft twisting in the device and three deaths possibly associated with such an event.
The device assists in delivering blood from the heart to the rest of the body, the agency said, and is used for short-term support of patients who are at risk of death from end-stage left ventricular heart failure. The HeartMate 3 system includes a blood pump that is implanted in the space around the heart along with an outflow graft that connects the pump to the aorta. The recall covers all 4,878 units distributed nationwide since September 2017.
Abbott received FDA approval for the HeartMate 3 last August for patients awaiting a transplant. The regulatory action comes just three months after the company reported data from its MOMENTUM 3 study that showed the device improved survival and lowered rates of stroke and pump thrombosis. The company hopes to submit the data to FDA to support a destination therapy indication for the device.
The device was originally developed by Thoratec, which St. Jude Medical bought in 2015 before it was acquired by Abbott for $25 billion in 2017 following regulatory approval.