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Cochlear Nucleus CI500 Series Recall

Cochlear Nucleus CI500 Series Recall

Last month, Cochlear Ltd., sent a clinical update to physicians which addressed its own failure analysis investigation regarding the CI500 series implant, confirming a flaw in the manufacturing process.

Cochlear Ltd., advises that the results of its investigation "point to a loss of hermiticity" within the device, which contains electrodes that are designed to stimulate the cochlea's hearing nerve subsequent to implant.

Now Cochlear has identified what it deems to be "unexpected variations in the brazing process" during manufacturing which has resulted in these CI500 devices being susceptible to the development of microcracks in their respective braze joints at later stages of the manufacturing process. The microcracks, in turn, allow water or moisture to enter the device and short circuit one of the four, internal diodes, resulting in device failure.

As previously noted in our blog entries, Cochlear Americas is sending letters to consumers with implanted devices, and to the parents of minors who have experienced device failure. Shoop | A Professional Law Corporation Law recommends that patients and parents of minors not release any of their rights to recovery for injuries sustained and financial losses, without first consulting an attorney who has substantial experience in the investigation of defective products, and litigating cases involving defective medical devices.

If you or a family member has suffered a failure of the Cochlear Ltd., CI500 series implant, contact Shoop | A Professional Law Corporation today to speak with an experienced Los Angeles product liability attorney, toll free, at (866) 884-1717.