Shares of St. Jude Medical (STJ.N) tumbled more than 13 percent on Wednesday as a report by U.S. health regulators raised fresh safety concerns about one of the company's leads used with implantable defibrillators, analysts said.
The U.S. Food and Drug Administration said in the report that design verification activities in one of St. Jude's leads, called Durata, were inadequate. The leads are wires connecting an implantable heart defibrillator to the heart.
St. Jude shares were down $4.65 at $31.06 in afternoon trading on the New York Stock Exchange, off the day's low of $30.25, which was the lowest price in almost 3 years.
Shares of the company's competitors in the market for defibrillator leads advanced. Boston Scientific Corp (BSX.N), the third largest maker of leads, added 21 cents to $5.44, while Medtronic Inc (MDT.N), the market leader, rose 9 cents to $42.75.
An earlier generation of Durata, called Riata, was recalled last year because the insulation wore away, exposing wire cables, and there are concerns that Durata may have the same issues, said Goldman Sachs analyst David Roman.
"The FDA announcement is likely to put further pressure on St. Jude's US Implantable Cardioverter Defibrillator (ICD) business," Roman said in a research note.
"Should the company's entire U.S. ICD business be implicated, we see the total revenue at risk at $200 million. Further, there will likely be substantial costs associated with remediation. In similar scenarios, it is not uncommon to see remediation costs exceed $100 million," Roman said.
St. Jude, which had sales of $5.61 billion in 2011, declined to comment, saying its communications with regulatory agencies were confidential.
During its October 17 earnings call with analysts, St. Jude management had raised the possibility that it may get a warning letter from the FDA.
"The new disclosures add a new element of risk, given that the FDA highlighted quality control processes as a concern," Roman said.
(Reporting by Debra Sherman; Editing by Tim Dobbyn and Bernadette Baum)