Events

Device Recall IVUS Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Volcano 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
    71881
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2718-2015
  • 사례 시작날짜
    2015-07-22
  • 사례 출판 날짜
    2015-09-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139266
  • 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 for crossing total occlusions - Product Code PDU
  • 원인
    Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the pioneer plus intravascular ultrasound guided re-entry catheters.
  • 조치
    The Volcano Corporation sent an Urgent Medical Device Recall letter dated July 22, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine and return all affected product in their inventory. Customers were also asked to complete the attached form and fax back to 866-723-2482. Customers with questions were instructed to call 866-861-8923. For questions regarding this recall call 978-439-3586.

Device

Device Recall IVUS Catheter
  • 모델명 / 제조번호(시리얼번호)
    Product Code PPLUS20; All lots
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
  • 제품 설명
    Volcano Pioneer Plus Re-Entry Catheter; || Product Code PPLUS20, Catheter for Crossing Total Occlusions. || Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • 제조사 주소
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA