Z-1826-2010

Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050. Single Use, Rx only...

Name: Z-1826-2010 Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050. 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. Covered - 10/30/15 Catalog Number: M00569050. 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-1826-2010
Status: Terminated
Initiated: 2010-05-17
Posted: 2010-06-25
Terminated: 2011-10-20
Recalling firm: Boston Scientific Corporation
Product: Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050. 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: 9703315 9714662 9714664 9821713 9821714 11037142 11037488 11065953 11067756 11085020 11107374 11107379 11119412 11120147 11187951 11187955 11329333 11330281 11356485 11356486 11393422 11393424 11458543 11459948 11506685 11506686 11541160 11541162 11578196 11578520 11597599 11597682 11610973 11610975 11678541 11678549 11696764 11696767 11753789 11753920 11787647 11787649 11821207 11883892 11883922 11888074 11888321 11895796 11895845 11907389 11907390 11963638 11964061 12033762 12033763 12101027 12101029 12113346 12113347 12140516 12140517 12150322 12150326 12217034 12217323 12225070 12225213 12251730 12251733 12284357 12312841 12329238 12334705 12377720 12409688 12414272 12426158 12552665 12571603 12620323 12643126 12654667 12707139 12739832 12746937 12778328 12831272 12831461 12851487 12868350 12897747 12933682 12975410 12989155 12992395 12992922 13074849 13149043 13167175 13171927 13204146 13218651 13220534

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)