Agency orders the company to collect data on the wire insulation function
Silver Spring, Maryland–(ENEWSPF)–August 16, 2012. The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into the heart.
The…
