Z-2316-2010

Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) Material/Catalog...

Name: Z-2316-2010 Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) Material/Catalog...
Creator: Boston Scientific Corporation
Published: 2010-07-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-07-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) Material/Catalog Number: M00513720 on 2010-07-15. The reason FDA records is "Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2316-2010
Status: Terminated
Initiated: 2010-07-15
Posted: 2010-08-31
Terminated: 2011-10-14
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) Material/Catalog Number: M00513720.
Product code: ESW Prosthesis, Esophageal
Reason for recall: Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
Root cause tag: manufacturing process
FDA 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 in commerce: 0
Distribution: Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden
Product codes and lots: Lot/Batch Number: 13450513

Product code ESW

K091816Class IIUltraflex Esophageal Ng Stent SystemBoston Scientific Corporation / cleared 2009-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)