Events

Rappel de ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LIVANOVA CANADA CORP..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    23038
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-10-06
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    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.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    HC