The Food and Drug Administration said Wednesday that a delivery system used by physicians to insert heart implants has been recalled by St. Jude Medical. According to the FDA, a wire inside the system is susceptible to fracturing, which could seriously injure patients and possibly lead to death.
The recall comes as St. Jude faces other regulatory issues, including FDA concerns about one of its manufacturing facilities in California.
The company's Amplatzer TorqVue delivery system is used to mend holes in the upper chambers of the heart. The devices recalled by St. Jude were manufactured between Aug. 24 and Sept. 24, 2012.
The FDA issued a statement today, classifying the company’s action as a Class I recall. A Class I recall means patients treated with the devices could be seriously injured or killed.
St. Jude Medical makes a variety of medical devices, including heart devices, such as pacemakers and implantable defibrillators to correct dangerous and irregular heartbeats.
In recent years, the company has struggled to address quality issues involving wires it used to attach its defibrillators to the heart. As a result, St. Jude stopped selling its Riata wires in late 2010 due to concerns about their insulation.
It also recalled the devices in late 2011, as well as in 2012, when the company recalled two other wires – QuickSite and QuickFlex. In the United States, approximately 79,000 Riata leads are implanted in patients.
The FDA ordered St. Jude to conduct a three-year study to learn more about the risk of insulation failure.