Devices

Device Recall Ultraflex tracheobronchial Stent System

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9820027 9820415 11092859 11093048 11752551 11962126 11962127
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

제조사

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “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

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Device Recall Ultraflex tracheobronchial Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9660870 9660872 9683259 9684033 9825237 9825239 11020615 11021161 11045326 11046908 11092500 11092870 11100790 11101034 11179772 11180064 11221518 11286599 11291273 11397900 11586714 11586715 11630143 11630145 11665462 11665465 11682848 11682993 11722727 11722780 11740953 11740954 11767032 11767102 11791247 11791249 11808612 11809670 11858089 11858099 11858579 11858749 11864991 11864994 11890538   11890539 11993334 11993685 12054532 12054538 12066671 12066674 12088721 12088722 12119772 12119773 12150166 12150167 12166898 12167101 12201772 12201774 12233042 12233045 12239685 12239686 12273120 12273121 12371428 12386419 12441414 12554477 12607521 12624788 12652041 12728696 12732815 12746858 12753767 12781521 12832159 12836470 12849336 12862447 12933275 13081073 13110153 13119400 13203258 13236093 13318985
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex tracheobronchial Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9730258 9825738 9825746 11147367 11147373 11223562 11223563 11748615 11748616 11887697 11887698 12124979 12125049 12232145 12232151 12370304 12467916 12755428 12914233 12947902
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Tracheobronchial Stent System. Uncovered - 8/40 Catalog Number: M00568930. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex tracheobronchial Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9816662 9816664 9825225 9825231 11040448 11041182 11078192 11078420 11093973 11093975 11108899 11110944 11162018 11191140 11191143 11318358 11318707 11412065 11412066 11428368 11428370 11522460 11522461 11559400 11559402 11593826 11593832 11626022 11626025 11659418 11659419 11666874 11666875 11682980 11682981 11722921 11722925 11734945 11756575 11756620 11782914 11782919 11792137 11792360 11825611 11825614 11829608 11829612 11846116 11846118 11902527 11903035 11927690 11927691 11943670 11943683 11973645 11973646 12035398 12035641 12051921 12089897 12089898 12122981 12143396 12143721 12197267 12197268 12205131 12205132 12238955 12238956 12274500 12274503 12314919 12318374 12391990 12398060 12404315 12491821 12500427 12536945 12587048 12603447 12606861 12619342 12635155 12675579 12729536 12743685 12771606 12844953 12888561 12906495 12989820 13016857 13064646 13071656 13075798 13103652 13119112 13173450 13188899 13191108 13218308 13221250 13315928
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog Number: M00568940. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex tracheobronchial Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9819553 9819558 11057820 11057934 11128481 11128701 11188630 11188633 11254268 11254269 11327810 11327811 11486465 11486466 11591307 11648322 11648324 11687601 11740562 11792533 11828568 11828569 11891601 11933261 11933262 12150199 12295530 12305996 12395349 12463767 12517752 12602517 12619264 12652845 12685511 12687464 12862108 12870991 13074818 13103999 13129113 13138519 13203489
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex tracheobronchial Stent System
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    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.
  • Manufacturer
    Boston Scientific Corporation
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