Medtronic Lead Recall

Medtronic issued a recall of the Sprint Fidelis lead wire after learning of at least five deaths among patients with defibrillators that used the leads.

The company says that the Sprint Fidelis leads are more than twice as likely to fracture as another type of Medtronic defibrillator lead, which could place patients at an increased risk of serious injury or death.

A fracture in one of the Sprint Fidelis leads could cause a defibrillator to deliver painful, unnecessary shocks to a patient’s heart. Broken lead wires could also cause the defibrillator to fail to deliver a life-saving jolt of electricity if the patient develops an irregular heartbeat, such as during a heart attack.

According to Medtronic, about one in 43 Sprint Fidelis leads will malfunction within 30 months after they are implanted, more than twice the rate as with another type of Medtronic defibrillator leads.

So far, the Food and Drug Administration has received more than 1,600 reports of injury or malfunction among patients with defibrillators that use the lead wires involved in the Sprint Fidelis lead recall.

Some experts believe that the Sprint Fidelis leads—which are the thinnest lead wires ever manufactured by Medtronic—may have been to fragile to be safely used with the company’s defibrillators.

Several patients who allege they were injured due to defibrillator wire problems with the lead wires have filed lawsuits against Medtronic.

These defibrillator recall lawsuits have alleged that Medtronic continued marketing the Sprint Fidelis leads despite the fact that it was aware they were more prone to fractures than its other lead wires.

Although most of the lead wires involved in the Sprint Fidelis recall involve defibrillators manufactured by Medtronic, some patients may be using defibrillators made by other companies which also contain Sprint Fidelis leads.