Z-1853-2010

Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. Single Use, Rx only...

Name: Z-1853-2010 Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. 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 - 20/60/45 Catalog Number: M00569580. 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-1853-2010
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 - 20/60/45 Catalog Number: M00569580. 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 Number: 9702666 9713744 9815286 9815735 9827448 11023940 11048031 11048060 11090552 11091623 11100787 11100789 11130407 11130409 11169593 11199527 11199535 11280856 11280880 11341089 11341176 11432241 11432242 11449851 11450165 11478740 11478748 11508004 11508006 11544543 11544548 11580979 11581280 11588652 11588654 11638613 11648449 11648451 11712580 11712582 11713706 11714530 11749295 11749401 11768151 11768153 11788880 11795319 11795584 11805726 11805727 11844354 11845372 11847118 11882868 11882870 11940557 11965234 11965643 11975795 11976130 12031087 12068298 12068464 12085102 12085111 12128423 12166213 12198180 12198183 12199117 12199299 12238417 12253760 12272254 12321133 12376164 12394715 12445215 12467922 12500371 12552399 12572753 12600206 12623799 12639192 12668979 12715336 12744279 12752674 12833389 12846410 12860388 12877943 12917360 12954186 12956938 12974683 12996101 13051719 13059606 13068104 13074855 13076093 13115832 13142196 13181128 13186398 13191494 13281348 13282288

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)