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-1862-2010
  • 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=92001
  • 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: 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

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