St. Judge Medical, the manufacturer of Riata ST leads, recalled the leads in November 2011 due to reports of premature erosion of the insulation around the electrical conductor wires, a condition called insulation failure. The company stopped selling the leads in late 2010, but it reported that as of 2011, approximately 79,000 Riata leads remained implanted in U.S. patients, according to the release.
Insulation failure may cause malfunctions resulting in potentially life-threatening abnormal heart rhythms, according to the release.
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