—#205630

Product

EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.

FDA product code: PIF — Gastrointestinal Tubes With Enteral Specific Connectors
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K161003
Affected lot / code info: UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.

Why it was recalled

Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On December 19, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE PRODUCT REMOVAL letters. Customers were instructed to cease further distribution or use of any remaining affected product. Distributors should forward the notice to their customers to ensure the recall is carried out to the end-user level. Customers were instructed to discontinue use and segregate affected product. Customers will receive a Return Goods Authorization (RGA) number after completing and returning their Reply Verification Tracking Form (RVTF). Customers will receive credit for returned affected product. Reach out to your local Boston Scientific representative with any questions.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: International distribution to the country of Japan only.

Timeline

Recall initiated: 2023-12-19
Posted by FDA: 2024-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205630. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.