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-1859-2010
  • 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=91998
  • 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 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

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