Events

Rappel de GALEO PRO

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIOTRONIK CANADA 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
    23403
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2016-11-14
  • 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 recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (ptfe) coating on parts of these devices.

Device

GALEO PRO
  • Modèle / numéro de série
    Model Catalog: 389791 (Lot serial: >100 numbers contact mfg); Model Catalog: 389788 (Lot serial: >100 numbers contact mfg); Model Catalog: 389787 (Lot serial: >100 numbers contact mfg); Model Catalog: 389786 (Lot serial: >100 numbers contact mfg); Model Catalog: 389785 (Lot serial: >100 numbers contact mfg); Model Catalog: 389784 (Lot serial: >100 numbers contact mfg); Model Catalog: 389783 (Lot serial: >100 numbers contact mfg); Model Catalog: 389782 (Lot serial: >100 numbers contact mfg); Model Catalog: 389781 (Lot serial: >100 numbers contact mfg)
  • Description du dispositif
    GALEO PRO CORONARY GUIDEWIRE
  • Manufacturer
    BIOTRONIK CANADA INC

Manufacturer

BIOTRONIK CANADA INC
  • Adresse du fabricant
    TORONTO
  • Société-mère du fabricant (2017)
    Ms Holding Ii Se
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HC