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FDA classifies recall of Boston Scientific device as 'most serious'
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FDA classifies recall of Boston Scientific device as 'most serious'
Apr 17, 2024 12:53 PM

April 17 (Reuters) - The U.S. Food and Drug

Administration on Wednesday classified a recall of Boston

Scientific's ( BSX ) 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 ( BSX ) 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.

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