UPDATE 1-FDA classifies recall of Boston Scientific device as 'most serious' [Yahoo! Finance]
Boston Scientific Corporation (BSX)
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Source: Yahoo! Finance
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 sai
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- 4/24/24 - Miss
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- 4/29/24 - Form DEFA14A
- 4/29/24 - Form 4
- 4/26/24 - Form 144
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