—#206388

Product

Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010

FDA product code: KRD — Device, Vascular, For Promoting Embolization
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K213385
Affected lot / code info: a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2024-02-20
Posted by FDA: 2024-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.