Events

Rappel de CRUISER HYDRO F

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
    20140
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-09-09
  • 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
    Specific lots potentially have decreased tensile strength of the distal tip when tested at three year shelf-life. two year shelf-life dated product is not affected.

Device

CRUISER HYDRO F
  • Modèle / numéro de série
    Model Catalog: 351456 (Lot serial: >10 numbers contact mfg); Model Catalog: 351455 (Lot serial: >10 numbers contact mfg); Model Catalog: 351457 (Lot serial: 01109002); Model Catalog: 351457 (Lot serial: 08099006); Model Catalog: 351457 (Lot serial: 10099008); Model Catalog: 351457 (Lot serial: 10099007); Model Catalog: 351457 (Lot serial: 01109001); Model Catalog: 351459 (Lot serial: 02109003); Model Catalog: 351459 (Lot serial: 9099001); Model Catalog: 351459 (Lot serial: 10099001); Model Catalog: 351459 (Lot serial: 10099003); Model Catalog: 351458 (Lot serial: >10 numbers contact mfg)
  • Description du dispositif
    CRUISER HYDRO CORONARY AND PERIPHERAL ARTERY GUIDE WIRE F
  • 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