FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog Number: M00568960. 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-1821-2010
- Recalling firm
- Boston Scientific Corporation
- Product
- Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog Number: M00568960. 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
- Prosthesis, tracheal, expandable
- Distribution
- Worldwide Distribution - Only US distributed product is affected by recall
- Lot, serial or model codes
- Lot Numbers: 9720597 9755979 9756229 9813932 9814314 11034603 11035130 11063713 11063717 11093465 11093640 11153776 11153778 11186490 11186672 11218848 11218850 11297029 11374028 11374029 11392183 11392185 11533277 11533278 11544884 11544888 11590117 11590118 11670373 11670374 11682020 11682021 11738236 11738238 11751778 11751962 11783448 11783449 11820117 11820400 11847074 11847076 11880513 11880514 11890238 11890239 11909647 11909649 12011299 12011504 12035650 12035653 12103761 12126706 12145708 12145716 12174398 12174442 12176836 12176838 12247707 12247719 12256107 12256112 12274740 12274757 12404311 12425971 12469263 12511836 12554701 12591792 12644752 12668989 12691285 12742109 12834559 12835799 12847349 12863315 12872341 12982802 13115358 13120034 13136943 13148608 13313933
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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