Medical Device Recall: Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Boston Scientific Corporation · February 20, 2024
Reason for Recall
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
Distribution
US
Quantity Affected
985 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1374-2024
Status: ongoing
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