Events

Anastaflo Intravascular Shunt ( Carotid artery shunt) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Edwards Lifesciences 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-2013-RN-00810-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-08-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00810-1
  • 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 post market surveillance data review, edwards lifesciences has identified a potential health risk to patients undergoing by-pass surgery when an anastaflo intravascular shunt is used. edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. there have been no reports of injuries in any of these complaints. no events have been reported in australia.
  • 조치
    Customers are asked to quarantine affected stock and return all devices with remaining shelf life to Edwards Lifesciences. Customers can contact Edwards Lifesciences to obtain replacement product.

Device

Anastaflo Intravascular Shunt ( Carotid artery shunt)

Manufacturer

Edwards Lifesciences Pty Ltd