(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific’s device used to block blood flow during excessive bleeding or hemorrhaging as “most serious”.
An investigation showed that Boston’s device, Obsidio Embolic, when used with a specific technique posed a higher risk of bowel ischemia during procedures to stop gastrointestinal (GI) bleeding, the agency said.
Bowel ischemia describes disorders that occur when blood flow to your intestines decrease, causing severe abdominal pain.
The limited blood flow may lead to prolonged hospitalization or death, the FDA said.
The health regulator said there were 11 incidents reported, seven injuries, and two deaths related to this issue.
The recall is a correction, not a product removal, the FDA said.
On Feb. 21, Boston Scientific issued an advisory notice explaining that use of the aliquot technique is not recommended with Obsidio Embolic when used for procedures treating lower GI bleeding.
The company said on Wednesday the device’s performance could be altered when used with the aliquot technique. It continues to recommend that physicians not use the technique during the procedure.
Boston added that the device remains safe for use as labeled and continues to be available for treatment of internal bleeding and hemorrhaging.
(Reporting by Christy Santhosh; Editing by Maju Samuel)
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