NEW YORK (AP) -- The Food and Drug Administration is advising 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 FDA is recommending the scans for patients who have implantable heart devices with Riata or Riata ST wires. The wires are used to connect the devices to the heart, and they can deliver life-saving shocks if a patient's heart is not beating properly. However if the insulation is eroded, there is a greater chance the device could malfunction.
St. Jude stopped selling the Riata wires in late 2010 and recalled them in 2011. The FDA is also ordering St. Jude to conduct three-year studies on the risk of premature insulation failure.