FDA issues Class I recall on St. Jude's defibrillator leads

(Reuters) - St. Jude Medical Inc said the U.S. Food and Drug Administration has issued a Class I recall on faulty parts of its devices implanted into patients to control irregular heartbeats.

The devices, Optisure dual coil defibrillation leads, are connected to Implantable Cardioverter Defibrillators or ICDs, which monitor patients with abnormal heartbeats and then delivers an electric current to restore it to normal levels.

In patients with serious heartbeat variations, a failure in the device could result in cardiac arrest.

A Class 1 recall is the strictest form of recall issued by the health regulator, in situations where the use of faulty devices may cause serious injury or death.

St. Jude said it had advised physicians to monitor the patients who were implanted with the 447 Optisure leads that are the subject of the recall.

The device maker said it has not received any reports of compromised performance of the impacted Optisure leads.

The company said a technique used to remove excess medical adhesive around the shock coil may have damaged the insulation surrounding the Optisure leads.

As a result, the lead may not be able to deliver the required current needed to restore heartbeat, the company said.

Of the 447 damaged Optisure leads, 278 were distributed in the United States, the company said in a statement.

The company’s shares closed at $54.77 on the New York Stock Exchange.