Medtronic recalls defibrillator leads

Medtronic Inc. has voluntarily removed its Sprint Fidelis defibrillation leads from the market, citing the potential for the electronic wires to fracture, the company announced on Oct. 15. The leads are used to deliver therapy in defibrillators, including implantable cardioverter devices.

According to a statement by the Food and Drug Administration, current information indicates that fractures have occurred in less than 1% of the roughly 268,000 leads implanted worldwide. The agency said the leads should no longer be implanted in patients, adding, “Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society recommend the routine surgical removal of a fractured lead because removal carries risks.”

FDA said it agrees with Medtronic’s recommendation that defibrillator settings be adjusted at the patient’s next scheduled visit with their doctor.

[ via AHA News Now ]

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