device · product 1 of 1
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
- Recall number
- Z-1374-2024
- Initiated
- February 20, 2024
- Classification
- Class I
- Status
- Ongoing
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 985 units
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES
Distribution pattern
US