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a woman with a cochlear implant

All You Need to Know About the Nucleus CI500 Recall

The cochlear implant, a surgically implanted device designed to provide a person with a moderate to significant sense of sound after suffering hearing loss, has faced recall issues in recent years.

More specifically, the Nucleus CI500 range of products manufactured by Cochlear Ltd. had to be recalled after distribution to 28,000 users.

Below, we discuss everything you need to know about this recall and how it may impact you.

The Nucleus CI500 Recall History

The Nucleus CI500 line was a popular type of cochlear implant and accounted for approximately 70% of cochlear device sales in 2011.

After being introduced to the market in 2009, however, the device experienced multiple post-implant failures. These failures were largely caused by moisture collecting in the devices that caused malfunctions in one or more diodes.

In light of these defects, Cochlear Ltd. issued a voluntary recall for the Nucleus CI500 range of cochlear implants in July of 2011.

UBS, a global financial services firm, has stated that “analysis suggests the moisture [in the implants] is not related to bodily fluid.” As such, it can be determined that the presence of this moisture indicates an obvious flaw in Cochlear Ltd.’s manufacturing process.

UBS also estimates that the failure rate for these devices has approached 6%.

Impacted by the Nucleus CI500 Failure? Contact Us Today

Cochlear Ltd. has contacted recipients of the Nucleus CI500 range of implants and has offered to work with patients’ insurance companies to replace defective products.

Our team here at Shoop | A Professional Law Corporation recommends that patients do not release their rights to Cochlear Ltd. without first consulting one of our experienced Los Angeles product liability attorneys who has access to substantial evidence in the investigation of defective medical devices.

If you or someone you love suffered a failure of a Cochlear Ltd. product, call us today at (866) 884-1717 to schedule a free consultation.