FDA classifies Boston Scientific's Obsidio Embolic device recall as "most serious" due to bowel ischemia risk during gastrointestinal bleeding procedures.
The FDA has classified a recall of Boston Scientific's Obsidio Embolic device, used for hemorrhaging treatment, as "most serious". An investigation revealed that when used with a specific technique, it posed a higher risk of bowel ischemia during gastrointestinal bleeding procedures. The FDA reported 11 incidents, 7 injuries, and 2 deaths related to the issue. The recall is a correction, not a product removal.
April 17, 2024
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