Urgent Safety Notice for Riata and Riata ST silicone insulated defibrillation leads, St. Jude Medical
2012.09.19
Product group Active implantable medical devices - defibrillators
Reference 05563/11
St. Jude Medical has issued a Field Safety Notice with recommendations regarding patients with Riata and Riata ST silicone insulated defibrillation (ICD) leads. The recommendations were already recently published by the German Cardiac Society (DGK). The leads show an increased incidence of insulation defects, particularly “inside-out” lead fracture where inner, separately insulated cables penetrate through the surrounding silicone of the lead body. The Advisory Notice is only available in German language.