Events

Device Recall Ultraflex tracheobronchial 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-1847-2010
  • 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=91914
  • 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, tracheal, expandable - Product Code JCT
  • 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 tracheobronchial Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 9802438 9825051 9825183 11028463 11096877 11134525 11134526 11155266 11183180 11183184 11190929 11190931 11196982 11222307 11222308 11322699 11322808 11342536 11344628 11412495 11412744 11430286 11471040 11471041 11502877 11502879 11520626 11520627 11560886 11560890 11573251 11573299 11623680 11643650 11643653 11721511 11721514 11741999 11742422 11744401 11749506 11749507 11772333 11772334 11790411   11790658 11800001 11800005 11809015 11809019 11841642 11841643 11847105 11847108 11847140 11882025 11883117 11883118 11889174 11893116 11894017 11894018 11996479 12018168 12052699 12052822 12071288 12071290 12082047 12082049 12177977 12194992 12207113 12207118 12227747   12227750 12342973 12343830 12655844 12670341   12981613 12993133 12249944 12249956 12254267 12254270 12302279 12337166 12339597 12408719 12446794 12467731 12561009 12589371 12608594 12626429 12714003 12747821 12777144 12853912 12884155 12902924 12932464 13069362 13078443 13147743 13190260 13194410 13240287
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Only US distributed product is affected by recall
  • 제품 설명
    Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • 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