FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
- Recall number
- Z-1374-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
- Status
- Open, Classified
- Initiated
- 2024-02-20
- Posted
- 2024-03-27
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 985 units
- Distribution
- US
- Lot, serial or model codes
- a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES
- 510(k) numbers
- ["K213385"]
- PMA numbers
- not on file
- Product code
- KRD
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28