St. Jude Amplatzer Heart Surgery Wire Recalled Due to Fracture Risk
St. Jude Medical is recalling a critical heart device due to problems with parts that may fracture, posing a serious and potentially life-threatening risk for patients undergoing heart surgery.
On Tuesday, the FDA announced a St. Jude Amplatzer TorqVue FX Delivery System recall after finding that the end of a core wire could potentially fracture. The recall comes less than a month after the FDA warned St. Jude that it would not approve any new high-risk medical devices until the company improves its manufacturing processes.
The Amplatzer is used to help close holes in the heart. According to the FDA, St. Jude sent a letter on January 17 to customers warning them to stop using the devices and to remove them from their inventory. St. Jude reported that the distal end of the core wire of the device could fracture in some cases, and the FDA has now classified the action as a Class I medical device recall, suggesting that the agency believes the Amplatzer wire fracture defects could lead to serious injury or death. However, there have been no reports of injuries associated with the recalled Amplatzer TorqVue heart surgery wires.
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The recall affects the Amplatzer TorqVue FX Delivery System used to deploy Amplatzer Occluder devices. They have model numbers of -ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80, 9-ITVFX12F45/80, and 9-ITVFX13F45/80. The affected units were manufactured from August 24, 2012 to September 24, 2012 and distributed between October 1, 2012 and January 9, 2013.
St. Jude Manufacturing Problems
St. Jude’s manufacturing procedures are already under close scrutiny by the FDA after a December 2011 recall of St. Jude Riata and Riata ST defibrillator lead wires, which were removed from the market amid problems where the insulation was prone to failing, which could leave the wires exposed inside the body.
A growing number of individuals throughout the United States are now pursuing a St. Jude Riata product liability lawsuit, alleging that manufacturing problems made the insulation weaker at certain points, allowing the wire to penetrate and become exposed inside the body.
On January 10, the FDA issued a warning letter to St. Jude following inspections at its Sylmar, California production facility. The FDA said the facility had too many quality control problems that have not been properly addressed. The agency said it will not approve any new Class III medical devices from St. Jude until the company adequately addresses those problems.
Class III medical devices are those which are generally classified as the most likely to harm a patient if something goes wrong, as well as devices for which the safety profile has not yet been established. The category includes pacemakers and many other forms of implants, as well as HIV diagnostic tests and automated external defibrillators.
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