Events

Device Recall Nexstent Carotid Stent and Monorail Delivery 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
    38117
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1161-2007
  • 사례 시작날짜
    2007-05-01
  • 사례 출판 날짜
    2007-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52984
  • 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
    carotid artery stent - Product Code NIM
  • 원인
    Boston scientific nexstent carotid stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.
  • 조치
    On May 1, 2007, Boston Scientific initiated a Customer Notification worldwide. On May 21, 2007 Boston Scientific expanded this field action to a recall/removal status for Germany. Affected customers were notified in Germany on May 24, 2007.

Device

Device Recall Nexstent Carotid Stent and Monorail Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Lots distributed in US: C64701, C64702, C64703, C64704, C64705, C64706, C64801, C64802, C64803, C64804, C70101, C70102, C70103, C70104, C70105, C70201, C70202, C70203, C70204, C70205, C70206, C70207, C70208, C70209, C70210, C70211, C70212, C70213, C70214, C70215, C70216, C70217, C70218, C70219, C70220, C70221, C70222, C70223, C70224, C70225, C70226, C70227, C70228, C70229, C70230, C70231, C70232, C70233, C70301. Lots distributed OUS: C51301, C52501, C52502, C52703, C61401, C61402, C61403, C61501, C61502, C61503, C61601, C61602, C61603, C61604, C61605, C61701, C61702, C61801, C61802, C61803, C61804, C61805, C61901, C61902,  C62001, C62002, C62003, C62004, C63701, C63901, C64001, C64002, C64101, C64102, C64501, C65101, C65102.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide, including USA, France, Italy, Germany, Belgium, Cyprus, Austria, Spain, Finland, Netherlands, Luxembourg, Romania , Czech Republic, Poland, Israel, Hungary, New Zealand, and Switzerland.
  • 제품 설명
    Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA