FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: 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.
- Recall number
- Z-1822-2010
- 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.
- 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: 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
- 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