Events

Device Recall Ultraflex Esophageal Stent System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    55784
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1861-2010
  • 사례 시작날짜
    2010-05-17
  • 사례 출판 날짜
    2010-06-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92000
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Prosthesis, esophageal - Product Code ESW
  • 원인
    Suture related device failures during deployment and repositioning of the stent.
  • 조치
    Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.

Device

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

Manufacturer

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