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.
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