Events

Rappel de SONIC - BRAIDED MICROCATHETER WITH GUIDEWIRE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par YOCAN MEDICAL SYSTEMS INC..

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
    48035
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-07-07
  • 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
    Balt extrusion received complaints related to ruptures or inflations of sonic microcatheters during the injections of contrast liquid or embolic agents. sonic microcatheters are designed to be thin and very flexible which allows them to reach very distal locations. special attention must be given during the injections in order to avoid any complications related to overpressure. hence a customer letter was created and is being distributed to remind users to follow the instructions in the ifu to prevent incidents due to overpressure.

Device

SONIC - BRAIDED MICROCATHETER WITH GUIDEWIRE
  • Modèle / numéro de série
    Model Catalog: SONIC 1.5F15 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F35 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F15SG (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F/15 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.2F/25 (Lot serial: ALL LOTS); Model Catalog: SONIC 1.5F15SG (Lot serial: ALL LOTS)
  • Description du dispositif
    SONIC - BRAIDED MICROCATHETER WITH PROGRESSIVE SUPPLENESS
  • Manufacturer
    YOCAN MEDICAL SYSTEMS INC.

Manufacturer

YOCAN MEDICAL SYSTEMS INC.