Events

MGuard Prime Coronary Stent System Embolic Protective Stent (EPS) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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
    RC-2014-RN-00545-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00545-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer, inspiremd, has initiated this recall action due to recent complaints of mguard prime eps dislodgements. these complaints have primarily occurred during the preparation of the mguard prime eps, upon removal of the protective sleeve, or during withdrawal of the mguard prime eps into the guide catheter during the procedure. these complaints have not resulted in any patient injury.
  • 조치
    Upon getting appropriate regulatory approval, InspireMD intends to perform a manufacturing enhancement to all unexpired units of the MGuard Prime EPS systems to improve stent retention and product performance.

Device

MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)
  • 모델명 / 제조번호(시리얼번호)
    MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)Multiple catalogue numbers affectedSupplied under the Special Access Scheme (SAS)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia