The U.S. Food and Drug Administration (FDA) reported on its website that St. Jude Medical Inc. recalled the wire that is used to place a device which closes the openings between the two upper chambers of the heart, due to the potential for it to fracture.
There have been no serious injuries or deaths to date associated with this product, which has been used in approximately 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 last month to immediately stop using the Amplatzer TorqVue FX Delivery System and were told to remove this product from their inventory, the FDA stated. The products were manufactured between August 24th and September 24th and distributed October 1st through January 9th.
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. About 79,000 U.S. heart patients still have the lead implanted in a blood vessel that leads to the heart.
Shares of St. Jude closed down 33 cents, or less than 1 percent, at $42.60 on the New York Stock Exchange.
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