FDA Issues Safety Warning On Recalled St. Jude ICD Leads.


The AP (8/17) reports that the Food and Drug Administration “on Thursday advised patients who have heart devices that include several types of wires made by St. Jude Medical Inc. to have an X-ray or another type of scan to test the wire's insulation.”

The Minneapolis Star Tribune (8/17, Hughlett) reports, “Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement that the majority of Riata leads 'continue to function normally and provide life-saving support for patients,'” but “the agency does not have enough information to determine the frequency and timing of insulation failure in these leads.”

The New York Times (8/17, Thomas, Subscription Publication) reports, however, that the agency “cautioned against routinely removing the leads, a warning that St. Jude underscored.”

MedPage Today (8/17, Kaiser) reports that the agency said, “Insulation failure may cause some of the electrical conductors inside Riata leads to move within or move entirely outside the outer lead insulation. These changes may be detectable on x-ray or fluoroscopic imaging.”

Medscape (8/17, Lowes) adds that the FDA is also “advising clinicians to consider remote monitoring of patients with Riata or Riata ST leads.”

According to the Wall Street Journal (8/17, Weaver, Subscription Publication), the FDA also ordered St. Jude Medical Inc. to conduct a new trial, focusing on Riata defibrillator leads recalled in December. Conversely, the agency also recommended that St. Jude continue adding patients to ongoing studies for its newer Durata ICD leads