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

FDA device recall Z-1374-2024 · posted 2024-03-27 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KRD

Quantity affected

985 units

Distribution

US

Date initiated

2024-02-20

Date posted

2024-03-27

Location

Maple Grove, MN

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