Events

ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 LIVANOVA CANADA 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
    23038
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-10-06
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    The manufacturer is updating and consolidating the instructions for use (ifu) for the listed products. included is a new bailout procedure for snapped/broken release wires in the anaconda stent graft system ifu and a new caution in the deployment instructions for the anaconda aaa stent graft system aortic cuff. in addition three current ifus/ifu supplements for the anaconda one-lok aaa stent graft system anaconda iliac stent graft system and anaconda aaa stent graft system aortic cuff have been combined into one main ifu (part no. 301-179).

Device

ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: OLB23 (Lot serial: ALL LOTS); Model Catalog: OLB25 (Lot serial: ALL LOTS); Model Catalog: OLB28 (Lot serial: ALL LOTS); Model Catalog: OLB32 (Lot serial: ALL LOTS); Model Catalog: L12X160 (Lot serial: ALL LOTS); Model Catalog: TL1210X080 (Lot serial: ALL LOTS); Model Catalog: L12 X 120 (Lot serial: ALL LOTS); Model Catalog: L12 X 100 (Lot serial: ALL LOTS); Model Catalog: L12 X 080 (Lot serial: ALL LOTS); Model Catalog: L12 X 060 (Lot serial: ALL LOTS); Model Catalog: L17X120 (Lot serial: ALL LOTS); Model Catalog: L16X140 (Lot serial: ALL LOTS); Model Catalog: L16X120 (Lot serial: ALL LOTS); Model Catalog: L15X080 (Lot serial: ALL LOTS); Model Catalog: L13X140 (Lot serial: ALL LOTS); Model Catalog: L13X120 (Lot serial: ALL LOTS); Model Catalog: L13X060 (Lot serial: ALL LOTS); Model Catalog: L12X140 (Lot serial: ALL LOTS); Model Catalog: L12X120 (Lot serial: ALL LOTS); Model Catalog: L12X100 (Lot serial: ALL LOTS); Model Catalog: L12X080 (Lot serial: ALL LOTS); Model Catalog: L12X060 (Lot seria
  • 제품 설명
    ANACONDA STENT GRAFT SYSTEM ONE-LOK BIFURCATE BODY;ANACONDA STENT GRAFT SYSTEM ILIAC LEG;ANACONDA STENT GRAFT FLARED AND TAPERED LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR);ANACONDA STENT GRAFT ILIAC LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR);ANACONDA STENT GR
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • 제조사 주소
    MARKHAM
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    HC