FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9) Material/UPN/Catalog Number: M00513850
- Recall number
- Z-2320-2010
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9) Material/UPN/Catalog Number: M00513850
- Status
- Terminated
- Initiated
- 2010-07-15
- Posted
- 2010-08-31
- Terminated
- 2011-10-14
- Reason
- Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Root cause
- Process control
- Action
- Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.
- Quantity
- 8 units
- Distribution
- Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden
- Lot, serial or model codes
- Lot/Batch Number: 13435072
- 510(k) numbers
- ["K091816"]
- PMA numbers
- not on file
- Product code
- ESW
- 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