Z-1823-2010

Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Single Use, Rx only...

Name: Z-1823-2010 Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Single Use, Rx only...
Creator: Boston Scientific Corporation
Published: 2010-05-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-05-17 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for... on 2010-05-17. The reason FDA records is "Suture related device failures during deployment and repositioning of the stent". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1823-2010
Status: Terminated
Initiated: 2010-05-17
Posted: 2010-06-25
Terminated: 2011-10-20
Recalling firm: Boston Scientific Corporation
Product: Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
Product code: JCT Prosthesis, Tracheal, Expandable
Reason for recall: Suture related device failures during deployment and repositioning of the stent
Root cause tag: design
FDA root cause: Device Design
Action: Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.
Distribution: Worldwide Distribution - Only US distributed product is affected by recall
Product codes and lots: Lot Numbers: 9790074 9790076 11003371 11003538 11059367 11118676 11118678 11187506 11187507 11242343 11242356 11270352 11296916 11296917 11377103 11377104 11433735 11434016 11470448 11487990 11488029 11514456 11514458 11554796 11554991 11610744 11639021 11639030 11677818 11678048 11757152 11757154 11793164 11793166 11837438 11837483 11876610 11876622 11979808 11979811 12025013 12025143 12054670 12054671 12066948 12066951 12092005 12147149 12147208 12163806 12163809 12184724 12184725 12185876 12185878 12269162 12269163 12277634 12277635 12545679 12600436 12621164 12702786 12723775 12740615 12830189 12935877 13165824 13187801 13207649 13230712

Product code JCT

K012883Class IIUltraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent SystemBoston Scientific Corp / cleared 2001-10-12

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)