Medtronic Recalls Heart Device
Some University of Michigan Health System pediatric and adult heart patients are affected by a recall that was announced by medical device manufacturer Medtronic and the U.S. Food and Drug Administration on October 15.
The recall is for a part called a "lead" within a type of implantable heart device that is used to regulate heart rhythm. The recall means that the devices will no longer be used in new patients, and that existing patients' devices need to be checked.
The recall is taking place because the leads could malfunction and interrupt the ability of the device to control the pace of a patient's heartbeat - or could cause a patient to get an unnecessary shock. Fortunately, only a small number of the recalled leads have been demonstrated to be defective.
At UMHS, the recall affects approximately 500 patients. About 450 of them are adults treated at the U-M Cardiovascular Center and University Hospital, and about 50 are children and teenagers treated at the Michigan Congenital Heart Center at C.S. Mott Children's Hospital.