STJ ST. Jude Medical, Inc.

   By Ezequiel Minaya 
 

St. Jude Medical Inc said Friday that U.S. regulators have classified its recall of defibrillator leads--cables that connect the heart to implantable defibrillators--as a Class 1 advisory, its most urgent level.

St. Jude said in a press release that the recall is linked to 447 Optisure brand leads, of which 278 were distributed in the U.S. Defibrillators are used to quell abnormal heart rhythms with an electrical zap.

A representative from the U.S. Food and Drug Administration, which issued the advisory, was unavailable for comment. The FDA defines a Class 1 recall as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

St. Jude said the Optisure leads involved in the recall may have been damaged during manufacturing. The company said it had not received any reports of malfunctions or injury related to the product and that all physicians with patients affected by the recall have been notified.

St. Jude said it began the process of notification in November, before the recent upgraded advisory. The device-maker said the lead could fail to deliver the correct voltage to the heart. St. Jude Medical said it was in the process of drawing up an updated advisory for physicians with recommendations.

St. Jude said there was a total of nine patients in the U.S. with the leads who also weren't equipped with a failsafe device called the DynamicTx. The company has reached out to their physicians and recommended a series of tests.

The St. Paul, Minn., company reported earlier this month that revenue for its December quarter would be $1.45 billion, short of the $1.48 billion analysts predicted. Full results were slated for release on Jan. 27.

Shares of the company have slipped 11% over the past three months, closing Friday at $54.77, according to FactSet.

St. Jude has had problems with leads before. In 2011, St. Jude recalled Riata defibrillator leads that were linked to patient deaths.

Write to Ezequiel Minaya at Ezequiel.Minaya@wsj.com

(END) Dow Jones Newswires

January 22, 2016 18:15 ET (23:15 GMT)

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