FDA Report Faults St. Jude For Handling Of Heart Device

Law360, New York (November 21, 2012, 6:28 PM EST) -- St. Jude Medical Inc. failed to properly carry out the design of the heart device wiring that succeeded a device that was recalled in 2011, according to a U.S. Food and Drug Administration inspection report released Tuesday.

A portion of the partially redacted report detailed inadequacies in the design process for the Durata defibrillator lead, as determined by an FDA employee during the inspection of the company's Sylmar, Calif., facility in September and October.

The Durata lead replaced St. Jude's Riata lead. The FDA issued its...
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