St. Jude Medical hit with Class I recall for faulty defibrillator leads

A letter recently sent by St. Jude Medical (NYSE:STJ) to customers regarding a problem with some of the device maker’s defibrillator leads has been classified as a Class I recall — for the most dangerous or defective products — by the U.S. Food and Drug Administration.

Although the medical device maker stopped selling the Riata line of leads last year, they were recalled because of the discovery that they had more potential than previously thought to hurt or kill patients. The wires used to connect the defibrillators to the heart may shock patients at inappropriate times or fail to deliver necessary therapy to others, according to St. Jude.

An advisory letter was sent to doctors on Nov. 28 along with recommended instructions for patient monitoring.

The leads remain implanted in 79,000 patients, St. Jude said.

Shares of St. Jude Medical have been in a decline since May, but sunk to a 52-week low on Thursday and fell another 2 percent to $32.93 on Friday. Just two weeks ago, St. Jude shares were trading above $38 after a boost from the approval of the anticipated Unify Quadra cardiac resynchronization therapy defibrillator.

A sluggish heart-rhythm sector has taken a toll on St. Jude; the company’s cardiac rhythm management devices, including defibrillators, provided 56 percent of its total revenue in 2010.