Z-1822-2010

Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970. Single Use, Rx only...

Name: Z-1822-2010 Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970. 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 - 12/40 Catalog Number: M00568970. 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-1822-2010
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 - 12/40 Catalog Number: M00568970. 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: 9664693 9666853 9695256 9698132 9739398 11000897 11000980 11054466 11054467 11062673 11062675 11114765 11150891 11150896 11162419 11162500 11184613 11184618 11202587 11202588 11224039 11224064 11440573 11440575 11496518 11496519 11537476 11582518 11582519 11611462 11611463 11648741 11648746 11677545 11677547 11686362 11735097 11756197 11756872 11773064 11773065 11792820 11792827 11824406 11824407 11864997 11864998 11870587 11870588 11876728 11926873 11926874 12010500 12010501 12012711 12069086 12069087 12080433 12094484 12094485 12218376 12218379 12221872 12222047 12277621 12277625 12403510 12413928 12514613 12562220 12608808 12622580 12691428 12836476 12907151 12918367 12921603 13097256 13106258 13136404 13138517 13229828 13233112 13233284

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)