FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590. 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-1854-2010
- Recalling firm
- Boston Scientific Corporation
- Product
- Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590. 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: 9649130 9649131 9818579 9818588 11107095 11170337 11170339 11222550 11397903 11448934 11513546 11555992 11595776 11704469 11759267 11759268 11794636 11794637 11809672 11809674 11847114 11877066 11877068 12029553 12029554 12074329 12074333 12088528 12088533 12216682 12266301 12266303 12412119 12551613 12572893 12616327 12639913 12744882 12745231 12834879 12862472 12881353 13016204 13055063 13086404 13176861 13282672 13284402
- 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