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St. Jude’s Riata Lead Garners FDA Recall Based on Risk of Death

Dec. 15 (Bloomberg) -- St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients.

The devices remain implanted in an estimated 79,000 U.S. patients, St. Paul, Minnesota-based St. Jude said today in a statement. The company voluntarily sent a letter to doctors on Nov. 28 informing them that the wires used to connect the devices to the heart have a higher failure rate than was previously known.

The FDA deemed the letter a Class 1 recall, its most serious designation, because of its potential risk of serious injury or patient death, the company said. The wires inside some leads can penetrate the insulation, compromising the device’s integrity. The devices may inappropriately shock some patients and fail to deliver necessary therapy to others, the company said. It’s not clear what health complications may stem from damaged leads that are still electrically intact, St. Jude said.

“At this time, no blanket statement can be made about clinical recommendations,” said Anne Curtis, chairwoman of medicine at the University at Buffalo in New York and a member of St. Jude’s medical advisory board, in the statement. “Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads.”

Patients who need frequent shocks from their defibrillator to restore a normal heart rhythm and those who are dependent on pacemakers may be at greater risk, the company said. Doctors may design individual treatment plans for those with the damaged wires based on their risk level and options should be discussed with patients, the company said.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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