FDA calls for imaging of recalled ICDs

Patients who have implantable cardioverter defibrillators with certain wire leads made by St. Jude Medical should have X-rays or other imaging to check for abnormalities in the insulation surrounding the lead, the Food and Drug Administration stated in an August safety advisory. 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. The agency is requiring the device maker to conduct post-market surveillance studies, and cautioned against removal of leads without evaluation of benefits and risks.

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