FDA Media Alert Detail

FDA Safety Alert

Early Alert: Angiographic Catheter Issue from Boston Scientific

  • U.S. Food and Drug Administration
  • August 28, 2026
  • ID: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-angiographic-catheter-issue-boston-scientific

FDA MedWatch Safety Alert

Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism

Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.