Devices

Device Recall Ultraflex Esophageal Stent System

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11716747 11719459 11721821 11729926 11729998 11731974 11731983 11734667 117401681 11748529 11748768 11752059 11757914 11766370 11767173 11770846 11776069 11777140 11781775 11784015 11787078 11793310 11794248 11799820 11801118 11802514 11803110 11809195 11810170 11811464 11820413 11821001 11822969 11826373 11831892 11838256 11838878 11839736 11844020 11846185 11846248 11846253 11846951 11846953 11858576 11861902 11863820 11871706 11875454 11876887 11880510 11883101 11891860 11892090 11893164 11898231 11898232 11905969 11909657 11913442 11926201 11926876 11930247 11930248 11940106 11942632 11945163 11947855 11947856 11958960 11958965 11960293 11960789 11966833 11967086 11974373 11980938 11983599 11985454 11991968 11994271 11994745 11995508 11997279 12000316 12002171 12020711 12028205 12031085 12036202 12071753 12081195 12088720 12090373 12103455 12104002 12113175 12120857 12125768 12126304 12130611 12132860 12143419 12167827 12170973 12174452 12177448 12181376 12183455 12185865 12199514 12202572 12204721 12205766 12206478 12215868 12217072 12221748 12222787 12224170 12224983 12226310 12230469 12236287 12241937 12242446 12247537 12256681 12260344 12261778 12270641 12277629 12277716 12284878 12286552 12292490 12294566 12295525 12298435 12298619 12299291 12303231 12317109 12322291 12322876 12336666 12339193 12350706 12356418 12358035 12359808 12369556 12373110 12374928 12375936 12377238 12378467 12391988 12402898 12411192 12448650 12458095 12464951 12468986 12469409 12493640 12495520 12504814 12513458 12521091 12530616 12535032 12535250 12545690 12551951 12553334 12562537 12566799 12577393 12579867 12589363 12590909 12650905 12650919 12651073 12651493 12651739 12658453 12671016 12676815 12690802 12696732 12722747 12723422 12752297 12754746 12758346 12759743 12763271 12771600 12837116 12853231 12859758 12861354 12864736 12867422 12869971 12872081 12878780 12880787 12891195 12895995 12899912 12914733 12920992 129280381 129318721
  • 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 - 18/23/12/9. Catalog Number M00513850. 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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