Events

Recall of HIRES 90K

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ADVANCED BIONICS LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26993
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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)
  • Product Description
    REMOVABLE MAGNET HIRES 90K
  • Manufacturer
    ADVANCED BIONICS LLC

Manufacturer

ADVANCED BIONICS LLC