St. Jude Medical (STJ) Device Exposes Safety Monitoring Failures, Doctor Says
2/15/2012 7:43:26 AM
St. Jude Medical Inc.’s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn’t spotted quickly enough because U.S. surveillance systems are lacking, according to an article in the New England Journal of Medicine. The device maker stopped selling the wires known as leads in December 2010, then the St. Paul, Minnesota-based company recalled the products a year later because they could break through Riata’s insulation coating and cause a potential failure. Still, 79,000 of the devices are inside U.S. patients, with questions remaining about their risks, said Robert Hauser, a cardiologist at the Minneapolis Heart Institute.