The Food and Drug Administration has recommended patients with implanted heart defibrillators with St. Jude Medical Riata leads have X-rays or other imaging scans to check for abnormalities in the insulation surrounding the lead.
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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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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