Device Recall Ultraflex tracheobronchial Stent System

  • Model / Serial
    Lot Numbers: 9828690 9828691 11084898 11084899 11207573 11207575 11503181 11503182 11631699 11631921 11710669 11710670 11750563 11750569 11807425 11877662 11957664 11957676 11977820 11977826 12105341 12105346 12297199 12297365 12305456 12305800 12411409 12482912 12485984 12591205 12624300 12650674 12836583 13168173 13200037
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

39 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 9806034 9806035 11502332 11502334 12333641
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 9775346 9820252 9821003 11073086 11125407 11162573 11162577 11209018 11209603 11409760 11425714 11425716 11480359 11482285 11542522 11542525 11592820 11631290 11753170 11771715 11801806 11801807 11871828 11871829 11926337 11926338 12049734 12180770 12237417 12278108 12367211 12374936 12410617 12423649 12536705 12564510 12592185 12701997 12722753 12905184 12939325 13010286 13058269 13133434 13151193
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 9819301 11041579 11041980 11095566 11095723 11200891 11258165 11258427 11441491 11482295 11482672 11526837 11527124 11580505 11627827 11666837 11666980 11753928 11753933 11869280 11869284 11878524 11878885 11968615 11968617 12065934 12065937 12084948 12084951 12185009 12185011 12317446 12394535 12562141 12641804 12672047 12836122 12913900 13105281 13183699
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 11021753 11021758 11480991 11480993 11721839 11722425 11859270 118641921
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 9710497 9710747 9822080 9822106 11112045   11112046 11184460 11184466 11201847 11201848 11431347 11477279 11477540 11576821 11624591 11661903 11662027 11768846 11768848 11873424 12025943 12025945 12110520 12110523 12163277 12235155 12235454 12270227 12375502 12407153 12470816 12531186 12604039 12618533 12650205 13131724 13314095
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
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