The Sprit Fidelis leads were recalled by their manufacturer, Medtronic, in October 2007 because they were twice as likely to break after being implanted as other Medtronic leads wires. Broken leads can cause the defibrillator to deliver repeated, painful shocks, which can be fatal. At the time of the Sprint Fidelis recall, the Food and Drug Administration reported that it had received at least 599 reports of malfunctioning Sprint Fidelis leads, including at least 204 patients who had received excessive shocks to the heart.

Because lead wires are implanted directly into the heart, surgery to remove them is dangerous and requires a surgeon who is experienced in lead wire removals. Although defibrillator lead wires can last for 15 years or more, some doctors are electing to remove their patients’ Sprint Fidelis leads when they undergo surgery to replace a defibrillator. In addition, about 5% of these leads that were originally implanted have had to be replaced because they failed.

Medtronic has advised patients to go to a hospital that is experienced in lead wire removal surgeries if they elect to have their Sprint Fidelis lead removed. Medical experts say that patients should ask a hospital how many lead removals it has performed, and choose a medical center that performs at least 50 of the surgeries per year.