FDA Says Boston Scientific Recalls Obsidio Conformable Embolic For Increased Bowel Ischemia Risk When Used For Lower GI Bleeding; Boston Scientific Recall Is A Correction, Not A Product Removal as A Class I Recall;11 Incidents Reported, Seven Injuries, And Two Deaths Related To Obsidio Embolic
Portfolio Pulse from Benzinga Newsdesk
The FDA announced that Boston Scientific is recalling its Obsidio Conformable Embolic due to an increased risk of bowel ischemia when used for lower GI bleeding. This recall is classified as a correction rather than a product removal and is considered a Class I recall. There have been 11 incidents reported, including seven injuries and two deaths related to the use of the Obsidio Embolic.
April 17, 2024 | 6:22 pm
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NEGATIVE IMPACT
Boston Scientific's recall of its Obsidio Conformable Embolic due to increased bowel ischemia risks could negatively impact investor confidence and the company's financial performance in the short term.
The recall of a medical product, especially with reported injuries and deaths, can lead to significant financial implications for the company, including potential legal liabilities, increased regulatory scrutiny, and damage to the company's reputation. As this is a Class I recall, the most serious type, it indicates a situation where there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death, further exacerbating the potential negative impact on Boston Scientific.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100