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Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
Boston Scientific Corporation is recalling Obsidio Embolic by issuing a correction. 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 poses a high risk of bowel ischemia. 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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. Please be aware, this recall is a correction, not a product removal.
Questions?
Customers with questions about this recall should contact their local Boston Scientific Representative.
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