Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding

Boston Scientific is updating use instructions for Obsidio Conformable Embolic due to a concern for risks with using this device anywhere in the gastrointestinal (GI) area. Previous serious adverse health consequences were associated with lower GI bleeding. Recent serious adverse health consequences included all GI bleeding.  

These updated instructions provide additional information (warnings and procedural instructions) to the recall that Boston Scientific issued on February 20, 2024.

This recall involves updating instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Questions?

Customers in the U.S. with questions about this recall should contact their local Boston Scientific Representative.