OBSIDIO recallZ-1374-2024 · Boston Scientific Corporation · initiated Feb 20, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT ADVISORY notice to its consignees via FedEx on 02/21/2024. The notice explained the use of the aliquot technique in not recommended for lower GI bleed embolization procedure due to the risk to the patient. The firm directed the consignee to immediately post the notice near the product to ensure the information is easily accessible to all users. For questions, please contact your local Boston Scientific Representative. Updated recall strategy: All Obsidio accounts were sent an updated Product Advisory, which includes the Customer Cover Letter, Customer Advisory Letter and Sample RVTF, to inform physicians of updated IFU warnings and instruction regarding delivery techniques. The customer notifications were sent on Friday, October 11, 2024, via delivery using Fed Ex, DHL or other equivalent service. Accounts are not asked to return affected Obsidio product.
Recall details
- Recall number
- Z-1374-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2024
- Posted by the FDA
- Mar 27, 2024
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 985 units
- Product code
- KRD
- FDA submissions
- K213385
- Distribution
- US
Product description
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Code information (models, lots, serial numbers)
a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- OBSIDIO™ M0013972101010Boston Scientific Corporation · Device, Vascular, for Promoting Embolization1 recall26 reports
- OBSIDIO™ M0013972001010Boston Scientific Corporation · Device, Vascular, for Promoting Embolization1 recall2 deaths5 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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