FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
- Recall number
- Z-1855-2010
- Recalling firm
- Boston Scientific Corporation
- Product
- Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
- Status
- Terminated
- Initiated
- 2010-05-17
- Posted
- 2010-06-25
- Terminated
- 2011-10-20
- Reason
- Suture related device failures during deployment and repositioning of the stent
- 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.
- Quantity
- not on file
- Distribution
- Worldwide Distribution - Only US distributed product is affected by recall
- Lot, serial or model codes
- Lot Numbers: 9667182 9667456 9678329 976661r 9783326 9784576 11005496 11005821 11055376 11109805 11110365 11111487 11111488 11124327 11124679 11129759 11182502 11203182 11203183 11219588 11219589 11262131 11277906 11279304 11320864 11320865 11327239 11327427 11379196 11379197 11389643 11389684 11466799 11514285 11514449 11551574 11551706 11603424 11609889 11609897 11621871 11621875 11723618 11741602 11741603 11790710 11790804 11824403 11842316 11900249 11900251 11965095 11965222 12018497 12018498 12072815 12072849 12124056 12124286 12126719 I 12182401 12182408 12203718 12203719 12233126 12273963 12273964 12311839 12344667 12350349 12355457 12414762 12503049 12573392 12634334 12673096 12730542 12741518 12749444 12763036 12828633 12883686 12954041 13068696 13104060 13176719 13203739 13204940 13209979
- 510(k) numbers
- ["K012883"]
- PMA numbers
- not on file
- Product code
- JCT
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28