CLEVELAND, Ohio — The Food and Drug Administration has recalled a heart device used at the Cleveland Clinic and University Hospitals to help some patients who have heart failure.
Doctors around the world have been notified about problems with the HeartMate 3 Left Ventricular Assist Device, made by global pharmaceutical company Abbott. The issues could lead to low blood flow or clotting.
Abbott is aware of three reported deaths possibly associated with outflow graft twisting, the company said in a statement. There have been 32 reports of device malfunctions worldwide, the statement said.