Events

Device Recall ENDOTAK RELIANCE SG 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific CRM Corp 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
    68700
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2147-2014
  • 사례 시작날짜
    2014-06-19
  • 사례 출판 날짜
    2014-08-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128470
  • 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
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • 원인
    A review of manufacturing test records for boston scientific endotak reliance implantable leads revealed a suspected test data recording error. specifically, some test results were recorded as "failed" without any other indication of failure. there are no reported injuries from the devices.
  • 조치
    Sales representatives hand delivered a Boston Scientific "Medical Device Retrieval" Letter dated June 19, 2014 or June 20, 2014 when they were retrieving the devices from the hospital shelves. The letter was addressed to Hospital Administrator. The letter described the problem, product being recalled and the retrieval of the device by Boston scientific sales representative. For further questions they can contact their local sales representative or Boston Scientific International Technical Services. Physicians were contacted via telephone starting on July 6, 2014. A Boston Scientific letter dated July 8, 2014 followed the telephone conversation. For further information physicians can contact their local Boston Scientific representative or Technical Services at 1-800-227-3422.

Device

Device Recall ENDOTAK RELIANCE SG
  • 모델명 / 제조번호(시리얼번호)
    Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
  • 제품 설명
    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. || Product Usage: || The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA