Events

Rappel de HIRES 90K

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

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
    26993
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-06-23
  • 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
    Advanced bionics (ab) is notifying implant surgeons about the removable magnet component of the hires 90k cochlear implant (model no. ci-1400-01 and ci-1400-02h). the magnet is designed to be surgically removable if the cochlear implant patieint needs to undergo an mri. ab reports that devices manufactured between may27 and june30 of 2005 may have a magnet laser welding defect. the magnets were made such that the metal case surrounding the magnet is not properly welded. a patient implanted an unwelded magnet could experience a decrease in the strength of the magnet over time leading to headpiece retention issues. ab is aware of 14 defective magnets. in 7 cases the unwelded magnet resulted in surgery and replacement of the magnet. 2 of the replacements were for devices sold in canada. an additional 5 potential cases outside of canada and the usa are under investigation. based on random sampling ab has determined the weld failure occurred at a rate of 1 in 126 devices. devices manufactured outside the above time frame were not affected.

Device

HIRES 90K
  • Modèle / numéro de série
    Model Catalog: CI-1400-01 (Lot serial: N/A); Model Catalog: CI-1400-02H (Lot serial: N/A); Model Catalog: CI 1400-01 (Lot serial: N/A)
  • Description du dispositif
    REMOVABLE MAGNET HIRES 90K
  • Manufacturer
    ADVANCED BIONICS LLC

Manufacturer

ADVANCED BIONICS LLC