Thoratec Recalls Heart-Disease Device Following FDA Warning

April 24, 2012
Thoratec is voluntarily recalling lots of its HeartMate II Left Ventricular Assist System after receiving multiple reports of product parts falling off during x-rays and surgeries, the FDA says. The reported incidence of the defect, disconnections of a bend relief designed to prevent kinking of the outflow conduit that connects the device pump to the ascending aorta, is relatively low but worrisome enough to spur a market correction, according to the California-based devicemaker.
The GMP Letter