ISSUE: 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.

 

According to St. Jude Medical, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the United States.

via Safety Alerts for Human Medical Products > St. Jude Medical Riata Implantable Cardioverter Defibrillator ICD Leads: Safety Communication – Premature Insulation Failure.

Bear this in mind when you’re underwriting pacemaker cases.