The FDA issued a Class 1 Recall of the HeartMate II Left Ventricular Assist System (LVAS) manufactured by the Thoratec Corporation due to the potential for the bend relief to become detached from its position around the proximal outflow graft. The detachment can cause the graft to kink or deform, leading to a “reduction of blood flow from the HeartMateII lVAS pump, pump/graft thrombosis, or perforation of the outflow graft”. The bend relief’s metal end may also be sharp, causing erosion and cutting of the outflow graft. Health Care providers should be aware that adverse health consequences, and even death, can occur.
The label has been updated with a caution statement and detailed instructions to ensure the bend relief does not become detached.
For additional details, read the complete FDA alert.