Law360, Chicago (August 16, 2012, 8:15 PM ET) -- The U.S. Food and Drug Administration on Thursday advised patients implanted with St. Jude Medical Inc.'s Riata heart device wiring to have X-rays performed to look for erosion, its first major action on the devices since it recalled them last year.
The agency issued its most urgent recall for Riata and Riata ST leads, which attach heart tissue to cardiac defibrillators, in December following reports that the insulation around the wiring was prematurely eroding. The erosion could cause defibrillators to malfunction, potentially killing the user....
FDA Pushes X-Rays For St. Jude Heart Device Recipients
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