FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
- Recall number
- Z-1153-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
- Status
- Open, Classified
- Initiated
- 2023-12-19
- Posted
- 2024-02-16
- Terminated
- not on file
- Reason
- 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
- Under Investigation by firm
- Action
- 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.
- Quantity
- 0 US; 74 OUS
- Distribution
- International distribution to the country of Japan only.
- Lot, serial or model codes
- UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.
- 510(k) numbers
- K161003
- PMA numbers
- not on file
- Product code
- PIF
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- 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