Voluntary recall notification for Nucleus® CI500 Cochlear Implant range
Posted Sep 14 2011 3:41pm
Cochlear Limited is undertaking a voluntary recall of the unimplanted Cochlear™ Nucleus® CI500 Cochlear Implant range.
While less than 1% of Nucleus CI512 Implants have failed since launch in 2009, Cochlear has identified a recent increase in the number of Nucleus CI512 Implant failures. Exercising the greatest caution and with utmost concern for our recipients in mind, Cochlear is undertaking a voluntary recall of unimplanted Cochlear Nucleus CI500 Series cochlear implants while it further investigates the issue.
No implants outside the Cochlear Nucleus CI500 Range are affected by this voluntary recall including Nucleus Freedom Implants which remain available.
The Nucleus 5 external devices (Nucleus CP810 Sound Processor) and any previous generation sound processors are not affected by this recall.
It is important to note that all existing Nucleus CI512 Implant recipients can continue to use their system as normal.
If a Nucleus CI512 Implant failure occurs, the implant safely shuts down. In the event of a failure, recipients can be re-implanted with the Nucleus Freedom Implant range which remains available. Nucleus Freedom is fully compatible with the Nucleus 5 Sound Processor which is not affected by this recall.
For people considering a cochlear implant, Cochlear recommends the use of the Nucleus Freedom Range of cochlear implants which are fully compatible with the Nucleus 5 Sound Processor (CP810 Sound Processor). This combination of Nucleus Freedom and Nucleus 5 Sound Processor does not sacrifice any of the performance benefits of the Nucleus 5 System.
For more than 25 years, cochlear implant reliability has been of paramount importance to Cochlear, and we remain committed to providing high quality, highly reliable cochlear implant systems.
We sincerely apologise for any concern this causes. If you have any questions regarding this please do not hesitate in contacting your local Cochlear office or visit the Cochlear website for more information.