Class I — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 |
| Quantity | 985 units |
| Distribution | US |
| Initiated | 2024-02-20 |
| Classified | 2024-03-27 |
| Recall number | Z-1374-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Boston Scientific Corporation (Z-1374-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94126/
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