FDA designates Boston Scientific device recall as ‘most severe’

The U.S. Food and Drug Administration has declared a recall of Boston Scientific’s device, Obsidio Embolic, used for blocking blood flow during excessive bleeding or hemorrhaging, as “most serious”. An investigation revealed that when the device is used with a specific technique, it poses a higher risk of bowel ischemia during procedures to stop gastrointestinal bleeding.

Bowel ischemia refers to disorders occurring when blood flow to the intestines decreases, resulting in severe abdominal pain. The FDA stated that the limited blood flow could lead to prolonged hospitalization or death. There have been 11 reported incidents, including seven injuries and two deaths related to this issue.

Boston Scientific issued an advisory notice on Feb. 21, recommending against using the aliquot technique with Obsidio Embolic for procedures treating lower GI bleeding. The company clarified that the device’s performance might be compromised when used with the aliquot technique and advised physicians against its use during the procedure.

Despite the recall, Boston Scientific assured that the device remains safe for use as labeled and is still available for the treatment of internal bleeding and hemorrhaging. The recall is categorized as a correction rather than a product removal, according to the FDA. This development underscores the importance of following proper techniques and guidelines to ensure patient safety and prevent adverse outcomes.