St Jude Medical Inc is recalling the wire used to put in place a device that closes openings between the two upper chambers of the heart, because of the potential for it to fracture, the U.S. Food and Drug Administration said Tuesday on its website.
There have been no serious injuries or deaths associated with the product, which has been used in about 120 procedures since it was introduced last year, St Jude spokeswoman Amy Jo Meyer said.
The maker of medical devices advised physicians in a letter on January 17 to stop using the product, called the Amplatzer TorqVue FX Delivery System, and remove it from their inventory, the FDA said. The products were manufactured between August 24 and September 24 and distributed October 1 through January 9.
St Jude recalled the wire because it saw the potential for it to fracture when used in situations involving certain cardiac anatomies and implant practices, Meyer said. Physicians may continue to use the previous version of the TorqVue Delivery System, which has a different design.
The latest recall follows a more extensive recall in 2010 of St Jude’s Riata defibrillator leads, which were found to have insulation that could erode. Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart.