WASHINGTON (Dec. 19, 2011)—The Food and Drug Administration has classified St. Jude Medical Inc.'s voluntary medical device advisory letter on Riata and Riata ST silicone defibrillation leads as a Class I Recall, St. Jude said in a press release.
St. Jude sent its advisory letter to doctors Nov. 28. The defibrillation leads in question, St. Jude said, may develop externalized conductors, which occur when an abrasion results in an outer insulation breach within the vascular or cardiac systems.
Although the clinical implications of externalized conductors aren't fully known at this time, the electrical abnormalities associated with them could alter the pace of defibrillation, or even cause the leads to fail, St. Jude said.
Potential risk of serious injury or death because of product malfunction moved the FDA to order an official recall, St. Jude said. Approximately 79,000 Riata and Riata ST leads remain in use in the U.S., the company said.