FDA Classifies Boston Scientific's Recall For Device To Stop Blood Flow As 'Most Serious' [Yahoo! Finance]
Boston Scientific Corporation (BSX)
Last boston scientific corporation earnings: 4/29 06:30 am
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Source: Yahoo! Finance
An investigation determined that delivery of Obsidio Embolic using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal (GI) bleeding embolization, implies a high risk of bowel ischemia. The most serious and the most common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy. Use of this product with the aliquot technique may prevent blood and oxygen flow to organs, including the small bowel (ischemia) or non-target embolization, all of which may lead to prolonged hospitalization, the need for additional surgery, or death. Eleven incidents were reported, seven injuries, and two deaths related to this issue. The FDA said that recall is a correction, not a product removal. On February 21, Boston Scientific issued an advisory notice explaining that the aliquot technique is not recommended with Obsidio Embolic when used for procedures treating lower GI bleedin
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BSX
Earnings
- 4/24/24 - Miss
BSX
Sec Filings
- 5/1/24 - Form 144
- 5/1/24 - Form 10-Q
- 5/1/24 - Form 144
- BSX's page on the SEC website