FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
- Recall number
- Z-1019-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
- Status
- Terminated
- Initiated
- 2003-06-26
- Posted
- 2003-07-15
- Terminated
- 2005-04-21
- Reason
- Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
- Root cause
- Other
- Action
- Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.
- Quantity
- 23 units
- Distribution
- CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
- Lot, serial or model codes
- Lot Number: 5404484
- 510(k) numbers
- ["K991056"]
- PMA numbers
- not on file
- Product code
- not on file
- 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