Events

Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd 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-00715-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00715-1
  • 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
    Through the investigation of the complaints, cordis and creganna-tactx have observed that the balloon of the affected product, which is covered with a hydrophilic coating, may exhibit resistance to the removal of the balloon cover. weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. use of a weakened catheter may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. there is no concern for patients who have already been treated successfully with the affected product.
  • 조치
    Johnson & Johnson Medical is advising end users that if unusual force is required during the removal of the shipping stylet and/or balloon cover, the unit is not be used. This warning is also being added to the product labelling.

Device

Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation C...
  • 모델명 / 제조번호(시리얼번호)
    Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion)All Catalog Numbers and all unexpired Lots
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd