Events

Wingman35 Crossing Catheters 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Diverse Devices 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-2017-RN-00578-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00578-1
  • 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 reflow medical, has identified specific lots of wingman35 crossing catheters may be prone to tip detachment. if a catheter tip detaches from the wingman 35 crossing catheter within the vasculature, it could cause injuries to blood vessel walls, thrombotic events, foreign body embolisation, heart attacks and death. the manufacturer has received no reports of injury or death associated with the tip failures.
  • 조치
    Diverse Devices is advising users to stop using and quarantine all affected products. Affected products are to be returned to Diverse Devices for replacement.

Device

Wingman35 Crossing Catheters
  • 모델명 / 제조번호(시리얼번호)
    Wingman35 Crossing CathetersWingman 35 Crossing Catheter, 65cmReference: WGM35065CELot Numbers: 15087074R1Wingman 35 Crossing Catheter, 90cmReference: WGM35090CELot Numbers:1505144R, 1508264, 1603214R2, 1605194RWingman 35 Crossing Catheter, 135cmReference: WGM35135CELot Numbers: 1505264, 1508204, 1604213R, 160620RARTG Number: 246377
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Diverse Devices Pty Ltd

Manufacturer

Diverse Devices Pty Ltd