Z-1848-2010

Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530. Single Use, Rx only...

Name: Z-1848-2010 Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530. 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 - 16/80/65 Catalog Number: M00569530. 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-1848-2010
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 - 16/80/65 Catalog Number: M00569530. 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: 9795348 9795351 11072288 11145414 11145416 11206284 11206295 11502622 11627566 11715171 11775940 11794241 11794243 11967261 11967263 12108333 12109170 12180191 12180721 12242449 12242450 12391764 12501651 12624797 12827512 12917370 13022711 13097248 13220248

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)