FDA: X-ray Patients Who Have Riata ICD Leads
The FDA issued a safety warning Thursday saying that patients with the recalled Riata implantable cardioverter defibrillator (ICD) leads from St. Jude Medical should be imaged to detect premature insulation erosion.
"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," according to the FDA statement .
The agency also has mandated that St. Jude conduct 3-year postmarket surveillance studies to collect clinical data related to lead insulation failure.