Device Recall Powerlink (R) System with IntuiTrak Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Endologix Inc 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
    53983
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0594-2010
  • 사례 시작날짜
    2009-11-25
  • 사례 출판 날짜
    2010-01-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • 원인
    This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. if this occurs, treatment may be delayed or interrupted. the firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health.
  • 조치
    The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.

Device

  • 모델명 / 제조번호(시리얼번호)
    MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
  • 제품 설명
    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA