Voluntary Recall Notification for Nucleus CI500 cochlear implant range

Monday 12 September 2011 - Cochlear has announced it is undertaking a voluntary recall on the unimplanted Cochlear Nucleus 500 cochlear implant range (its most recent implant) as a small percentage (less than 1%) of these implants have failed. There are NO health and safety risks associated with the implant. The System 5 processor is not affected by this recall.

The Shepherd Centre would like to reassure our families that for any children who already have this implant (this is only children that have been implanted since November 2009) there is NO action required at this stage. The system can continue to be used as normal and there are NO health or safety risks.

While Cochlear investigates the cause of this issue, it will not be supplying any further implants from the Nucleus 500 range and instead will switch to providing the Freedom implant range. The Freedom implant range is fully compatible with the System 5 processor.

The Shepherd Centre will continue to fully support Cochlear as the chosen manufacturer for our implant program. We remain confident in its implants, processors and the support they provide. We believe Cochlear continues to provide the best option for our children.

We recommend to our families who have surgery planned that they continue with their current planned date and instead use the Freedom implant, along with the System 5 processor. It is far more important to get a good implant in now, rather than waiting for a return of the Nucleus 500 in some weeks or even months time (especially for children under two years of age).

We believe that the Nucleus Freedom implant is a very high-quality implant (we have many children doing very well with this implant) and along with the most recent System 5 processor the children will receive excellent access to sound. To our knowledge this combination will provide at least as good access to sound as any other make of implant, and swapping manufacturers can be complicated and problematic. As a result we feel it is best for our families to continue with Cochlear.

We will be in contact with any families who are affected by this recall, however if you have any concerns about your child’s device please contact The Shepherd Centre immediately.

More information:
For families, donors and stakeholders who are concerned about the voluntary recall please contact The Shepherd Centre on 1800 020 030.

Media inquiries:
Lauren Sharkey
Palin Communications
0439 404 200
Lauren@palin.com.au