St. Jude’s ultra-thin defibrillator wires are part of a new recall for heart patients.
On January 13, St. Jude Medical Inc. issued a recall of the wire that is used to secure a device designed to close an opening which can occur in the heart between the two upper chambers. According to the recall, the wire has the potential to fracture, according to the U.S. Food and Drug Administration.
The Amplatzer TorqVue FX Delivery System has been in use since 2012; the product has been recalled by medical device manufacturer due to its potential for fracture when used in some implant practices and to repair some cardiac anatomies. All batches of the device have been recalled after a number of the wires fractured during surgery. While there have not yet been any reported deaths or serious injuries associated with the product, physicians have been advised to stop using the product and remove it from surgical inventory. Physicians have been advised to use a previous version of the same system which has a somewhat different design. The devices are considered a Class I recall; the patients who received the device are in danger of being seriously injured or killed if it fails.
This is the latest recall in the wake of a larger St. Jude’s recall in 2010, when the manufacturer’s Riata defibrillators were taken off the marker after they were found to have insulation capable of eroding. Almost 80,000 heart patients in the U.S. still have the implant in a blood vessel which leads to the heart.
Extracting defibrillator leads is a risky surgery; it is estimated that many patients with the Riata leads will continue to live with them rather than risk the surgery. Reportedly, two patients have died and one was seriously injured during surgery to remove faulty Riata leads. St. Jude Medical Inc. manufactures and distributes a wide variety of medical devices, implanted defibrillators and pacemakers. In 2012, the company recalled two other similar wires, QuickFlex and QuickSite.
The FDA has ordered St. Jude to conduct a three-year study in which to learn about the risk of insulation failure. The Riata was noted for its ultra-thin wires and was popular with surgeons, but a recent study has shown that 15 percent of patients who received the Riata defibrillator lead later experienced an “insulation breach” or “insulation abrasion,” where the defoliator wires protruded from the cable’s coating. In late 2011, the FDA issued a Class 1 recall for Riata leads when it was found that they were failing at a high rate.
If you have any concerns about your pacemaker or defibrillator or any surgical implants you have received, speak with a Waxahachie personal attorney at Hale Law Firm.