FDA Issues Safety Communication about St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads
Published: Aug 18, 2012
The Food and Drug Administration (FDA) is providing information and recommendations regarding safety concerns with the recalled Riata leads. These leads have an increased risk of premature insulation failure that can impact the lead's ability to function properly. Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD). ICD leads typically have layers of insulation that protect electrical conductor wires inside the lead.
Riata's manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure. St. Jude Medical stopped selling these leads in late 2010 but more than 227,000 Riata leads had been distributed worldwide. According to St. Jude Medical, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the United States.
Want to read the full alert and receive alert emails?
