FDA-Device2024-04-03Class I
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Boston Scientific Corporation
Hazard
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.
Sold states
US
Affected count
985 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2024Don't want to check this manually?
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