FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
- Recall number
- Z-0563-04
- Recalling firm
- Boston Scientific Corporation
- Product
- Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
- Status
- Terminated
- Initiated
- 2004-01-28
- Posted
- 2004-07-20
- Terminated
- 2006-06-28
- Reason
- Incorrect label states stent covered with 'Permalume Covering', product is uncovered
- Root cause
- Other
- Action
- Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
- Quantity
- 12 units
- Distribution
- CA, GA, , MD, NY, OR, ND, PA Netherlands
- Lot, serial or model codes
- Lot Number: 6023979
- 510(k) numbers
- ["K030107","K012752"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 3001451463
- Firm city
- Natick
- 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