FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
- Recall number
- Z-1012-2019
- Recalling firm
- Boston Scientific Corporation
- Product
- Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
- Status
- Terminated
- Initiated
- 2018-12-26
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- The sterile barrier may contain packaging seal defects.
- Root cause
- Other
- Action
- Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers.
- Quantity
- 75 units
- Distribution
- The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
- Lot, serial or model codes
- Lot 22960202
- 510(k) numbers
- ["K965147"]
- PMA numbers
- not on file
- Product code
- FGE
- 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