The QMN Weekly Bulletin

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