Devices

Device Recall Ultraflex Esophageal Stent System

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11716102 11718857 11721518 11729141 11730796 11734326 11737042 11740173 11742379 11747842 11748198 11748762 11751766 11752104 11754592 11756879 11758874 11770296 11776238 11776423 11776898 11781199 11783145 11784820 11786304 11786671 11788507 11793161 11800087 11800878 11801310 11802512 11807680 11808607 11810811 11814431 11818783 11819837 11820108 11820407 11822154 11822327 11827480 11829502 11838111   11839734 11841828 11845996 11846102 11846184 11846247 11846252 11846949 11859975 11861681 11861913 11863668 11877327 11877862 11880678 11883113 11891364 11893105 11896488 11900240 11914977 11925892 11927140 11928700 11929618 11929641 11931312 11943402 11944930 11947641 11958156 11958701 11959402 11959844 11961829 11962134 11963885 11965640 11966958 11968136 11975349 11977797 11984076 11984648 11987510   11995930 11999494 12007633 12009536 12019753 12019850 12020700 12030082 12031029 12031379 12033697 12034966 12067868 12072081 12075092 12080805 12086408 12088435 12089894 12094081 12094082 12110533 12110939 12112728 12114314 12122375 12131926 12133884 12140330 12143030 12145921 12148030 12149283 12160348 12168241 12185248 12187446 12198194 12202732 12205869 12216690 12220041 12220652 12221564 12223712   12224484 12224976 12225579 12235140 12235973 12253180 12253700 12256606 12267248 12271794 12274288 12274743 12276749 12284195 12284440 12293022 12295782 12297192 12304572 12310668 12314805 12320850 12323077 12329983 12330763 12336671 12336862 12340520 12341025 12342292 12347706 12350476 12356258 12360029 12366256 12373534 12386335 12389512 12397531 12406352 12419884 12432704 12438074 12438891 12439219   12447537 12448648 12459331 12464438 12468706 12490240 12490247 12500831 12503264 12508815 12508894 12512820 12512835 12516424 12520535 12530001 12534572 12547698 12548555 12552381 12553585 12567326 12568885 12577395 12642875 12643419 12645257 12654186 12678494 12686552 12690598 12722273 12723863 12780647 12827835 12844407 12846151 12847549 12849601 12853101 12855377 12860946 12862476 12864723 12866598   12868576 12880571 12884150 12884814 12887592 12888765 12895363 12896895 12899207 12900009 12902141 12906760 12912761 12918033 12920616 12921783 12929726 12932257 12932807
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/10/7. Catalog Number M00513840. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • 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 Esophageal Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11718271, 11744478, 11791957, 11824076, 11889563, 11889560, 11909873, 11979879, 12000591, 12032284, 12067614, 12085722, 12147676, 12177136, 12258645, 12273971, 12279726, 12279727, 12659132, 12668988, 12739530, 12865395
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/7. Catalog Number M00513700. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex Esophageal Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 11724999 11750562 11772144 11789124 11804527 11805916 11814267 11828772 11838215 11842853 11869860 11871017 11890226 11895585 11910600 11938641 11946094 11960111 11991499 12010105 12106264 12112949 12124527 12167829 12201387 12238992 12249808 12271795 12304585 12319567 12354941 12439846 12464020 12480567 12510365 12547605 12581227 12604481 12686690 12745544 12860643 12885056 12900596 12915092 12932252
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/10. Catalog Number M00513710. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex Esophageal Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11737197, 11773676, 11873568, 11930246, 11931993, 12106608, 12123123, 12321371, 12353709, 1242701, 12440418, 12458739, 12601203, 12603432, 12879476, 12898127, 12921104
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex Esophageal Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11717046 11719760 11722823 11730797 11735875 11739720 11741378 11749284 11755286 11758547 11766245 11766255 11770935 11772898 11782339 11782638 11784123 11787640 11788215 11793317 11793678 11799428 11801070 11808604 11809861 11813051 11823568 11825931 11826764 11828406 11829617 11830543 11844880 11844881 11846140 11846187 11846250 11846323 11846955 11846956 118592681 11860780 11862363 11875545 11876855   11878642 11878895 11881993 11894585 11900366 11902662 11941163 11941475 11944370 11945112 11958144 11962457 11964441 11964984 11975124 11976613 11978950 11980458 11985020 11991404 11996203 12000595 12014137 12014819 12025006 12026984 12029231 12030700 12031548 12071744 12074678 12080439 12089892 12089893 12093959 12101193 12101344 12107261 12110119 12111716 12119440 12121281 12130410 12143028 12157296   12160343 12163708 12174550 12176831 12178825 12183838 12186088 12190622 12194341 12194768 12198193 12200254 12204410 12209757 12216188 12218964 12223445 12225246 12234329 12238454 12241393 12246949 12249401 12252479 12253467 12262013 12266721 12268185 12269177 12272831 12273974 12275979 12296685 12297508 12298033 12331011 12331157 12348053 12351403 12356070 12359234 12359967 12365432 12368067 12368865   12374844 12392365 12401348 12404546 12409395 12412810 12444650 12448365 12452453 12459194 12462612 12498755 12502943 12513230 12530171 12537525 12545037 12545470 12561706 12565956 12581805 12589539 12606199 12616569 12620516 12672493 12702798 12704719 12739076 12772432 12827735 12830234 112844257 12863664, 12871880   12917368 12918287 12920840 12844257 12879017   12846812 12848138 12850863 12853691 12861342   12885055 12886776 12895814 12912169 12917194 12930021
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/10/7. Catalog Number M00513730. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Ultraflex Esophageal Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11717547 11724997 11730506 11733143 11735857 11744473 11747850 11748115 11748703 11749504 11755828 11757441 11766371 11771487 11773688 11782909 11784694 11788206 11791252 11793665 11800088 11810542 11813053 11814272 11823572 11827356 11830766 11842301 11844882 11846141 11846188 11846324 11846957 11846958 11860236 11863086 11872420 11874726 11875667 11883102 11889562 11895930 11897032 11901171 11931570 11941341 11942972 11945162 11946520 11951127 11969421 11982094 11985488 11991796 11992174 11996653 12002493 12011513 12025015 12025155 12026256 12027554 12031723 12034907 12072087 12073098 12087523 12104000 12114312 12120992 12127636 12144382 12149504 12155217 12156134 12159842 12160987 12162782 12163562 12164645 12176654 12177726 12179420 12180186 12186092 12194918 12202044 12203137 12219719 12221575 12223039 12224998 12225622 12230470 12242300 12246956 12254187 12256519 12260117 12266399 12267859 12269995 12270505 12278319 12310298 12315601 12317781 12318554 12319015 12320698 12322872 12333093 12334478 12339506 12348305 12351417 12354385 12356602 12370142 12371627 12375358 12378613 12384525 12386325 12387668 12396150 12440416 12444651 12448647 12450801 12457782 12492988 12498133 12501390 12513016 12520688 12534067 12551273 12566989 12583267 12600950 12621171 12645078 12645845 12657395 12669445 12673338 12703450 12740197 12741282 12741506 12743202 12757005 12763032 12827702 12829801 12829966 12830765 12830767 12832989 12844419 12849607 12850057 12859668 12864107 12865389 12869468 12870028 12888380 12889011 12898412 12908635 12912946 12928517
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/12/9. Catalog Number M00513740. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
  • Manufacturer
    Boston Scientific Corporation
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