FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Polyflex Esophageal Stent 20/16mm x 120mm
- Recall number
- Z-0819-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Polyflex Esophageal Stent 20/16mm x 120mm
- Status
- Terminated
- Initiated
- 2003-04-16
- Posted
- 2003-05-14
- Terminated
- 2004-07-20
- Reason
- Radiopaque marker bands may not be visible under fluoroscopy
- Root cause
- Other
- Action
- Boston Scientific notified domestic accounts by letter on April 16, 2003. The account wasinstructed to check inventory and return product. A Reply Verification form was provided to document amount of product in inventory.
- Quantity
- 1
- Distribution
- Nationwide
- Lot, serial or model codes
- Reorder Number: M00514280 Lot Numbers: 03101, 03071
- 510(k) numbers
- ["K010068"]
- PMA numbers
- not on file
- Product code
- ESW
- 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