Patients who have implantable cardioverter defibrillators with certain wire leads made by St. Jude Medical should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, the Food and Drug Administration said in a safety advisory on Aug. 16. The manufacturer recalled the “Riata” and “Riata ST” leads last November after reports of premature erosion of the insulation around the electrical conductor wires, which may malfunction and lead to potentially life-threatening abnormal heart rhythms.
The agency is requiring the device maker to conduct post-market surveillance studies, and cautioned against routine removal of leads without careful evaluation of benefits and risks to individual patients.
“The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “However, the agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the post-market surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions.”