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St. Jude shares plummet after FDA concerns

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The U.S. Food and Drug Administration says an inspection of a St. Jude Medical facility in California found significant safety concerns with the firm's handling of its Durata leads, a wire that connects an implanted defibrillator to a patient’s heart, the New York Times reports. The federal inspection report called St Jude's "design verification activities were inadequate."

A spokeswoman for the Little Canada-based medical company told the newspaper that none of the observations in the inspection report “identified a specific issue regarding the clinical or field performance of any of our products.”

Click here to read the full FDA report.

The previous version of Durata, known as Riata, was recalled last year after the insulation wore away and exposed the wire cables, Reuters reports. A Goldman Sachs analyst says there have been concerns that Durata leads may have similar issues.

In August, a prominent cardiologist at Abbott Northwestern Hospital in Minneapolis felt the new defibrillator leads were still problematic despite design changes.

Click here to follow St. Jude Medical's stock performance.

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Related

FDA approves new St. Jude Medical defibrillators

The Food and Drug Administration okayed the Little Canada-based company's Assura portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy devices. The new line is said to have "advanced sensing options designed to reduce the incidence of inappropriate shocks."

Minneapolis cardiologist: St. Jude defibrillator leads still problematic

Design changes to a key Little Canada-based St. Jude Medical Inc. heart device, including an added layer of insulation to reduce the risk of abrasions, do not prevent defects that could lead to device failure and death. That's according to prominent cardiologist Robert Hauser of Abbott Northwestern Hospital in Minneapolis who made the comments in a study published in the medical journal Europace. He tells the Pioneer Press, "I can't say the Durata lead is bad. I just can't say that it's good."