Events

Device Recall Peripheral Cutting Balloon Microsurgical Dilatation Device small 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
    34504
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0410-06
  • 사례 시작날짜
    2005-12-07
  • 사례 출판 날짜
    2006-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43970
  • 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
    Catheter, Angioplasty, Peripheral, Transluminal - Product Code LIT
  • 원인
    The distal shaft of the catheter may separate during withdrawal of the device from the patient. if the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
  • 조치
    All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.

Device

Device Recall Peripheral Cutting Balloon Microsurgical Dilatation Device small Monorail Delivery...
  • 모델명 / 제조번호(시리얼번호)
    Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey
  • 제품 설명
    The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 3574 Ruffin Rd, San Diego CA 92123-2597
  • Source
    USFDA