St. Jude Medical cops to Durata plant problems

St. Jude Medical

St. Jude Medical (NYSE:STJ) copped to quality control problems at the Sylmar, Calif., plant that makes its next-generation Durata defibrillator leads, saying it’s put measures in place to remedy the issues.

STJ shares plunged late last year after it said the federal watchdog agency might issue a warning letter to the St. Paul, Minn.-based medical device company. Share prices have since recovered, but investors are holding their breath until the possibility of a formal warning letter passes.

St. Jude stock ticked up 0.3% today as of about 1:50 p.m., to $37.29 each.

In a Nov. 7 letter to the FDA reviewed by the Wall Street Journal, St. Jude admitted to the issues flagged by the FDA after inspections of the Sylmar plant, saying it plans to improve training and quality-control procedures and promising specific steps to remedy the problems, according to the newspaper.

St. Jude has been busy calming fears about its next-generation Durata leads since recalling its Riata defibrillator wires amid much controversy about revision rates and potentially device-related deaths. Wall Street investors are keeping their eyes peeled for any sign of a problem with the Durata leads. In June 2012, a single report (later debunked) of a Durata lead failure similar to the kind that sank the Riata sent STJ shares plunging 6% in a single day.

In November 2012 the FDA released a report chiding St. Jude on 11 problems discovered at the Sylmar, Calif., manufacturing plant inspected in September and October, sending STJ shares down more than 11% in 1 day as investors recoiled from what some perceived as a potential withdrawal of the Durata products.

Last month a group of shareholders sued St. Jude, accusing the company and 3 executives of making "false and misleading statements" about the Durata leads.

 

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