Devices

Device Recall Ultraflex Esophageal Stent System

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 11720486 11741834 11750686 11788787 11804318 11814051 11824077 11846108 11870368 11870594 11909641 11931304 11974372 11982929 12001740 12019957 12074676 12157485 12176238 12184464 12229977 12240225 12297673 12305981 12406877 12464947 12536118 12571835 12882958 12914130 12931878
  • 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 - Proximal Release - 18/23/10. Catalog Number M00513810. 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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