There hasn't been a recall of any Medtronic defibrillator devices, but four models of Medtronic Inc.'s Sprint Fidelis defibrillation leads — models 6949, 6948, 6931 and 6930 — were recalled and distribution was voluntarily suspended in 2009, states the U.S. FDA. Defibrillation leads connect the defibrillator device to the heart.Continue Reading
Defibrillators are surgically implanted to monitor heart rhythms in patients at risk of sudden cardiac arrest, the FDA states. They prevent the heart from beating too fast by delivering electrical shocks to restore a normal rhythm. Medtronic recalled the Sprint Fidelis leads because of the potential for lead fractures, which could cause the defibrillator to deliver unnecessary shocks or to stop operating. The recall doesn't apply to Medtronic pacemakers, which keep the heart from beating too slowly.
Medtronic recommended that patients keep the recalled leads in place and either monitor their performance for signs of fracture or have replacement leads installed, states the FDA.
Medtronic continues to follow regularly the performance of Sprint Fidelis leads that are still in use through the company's Product Surveillance Registry and CareLink Network and third-party information, the company states. The data is reviewed by the Independent Physician Quality Panel and published on the Medtronic website, with updates every six months.Learn more about Cardiac Health