Recall archive / FDA device enforcement
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 — FDA record Z-1374-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 20, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 985 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1374-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 3, 2024
- Recall initiation date
- Feb 20, 2024
- Center classification date
- Mar 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.