Published by If a recalled Cochlear Nucleus CI512 implant failed, shut down, or stopped working and you needed revision surgery or suffered other losses, a legal review may help you understand your options.
Compensation may be available for medical expenses, corrective treatment, lost income, and other documented damages tied to an allegedly defective implant.
Table Of Contents
What’s the Problem?
The recall involved a serious reliability issue in the Cochlear Nucleus CI512 implant. FDA records state that the implant could shut down and cease to function. In practical terms, that means the device could stop delivering the auditory stimulation it was intended to provide.
For patients and families, an implant failure is not a small inconvenience. A cochlear implant is surgically placed and is meant to function inside the body over time. If it stops working, the consequences can include loss of hearing benefit, disruption of language development or communication, emotional stress, and the possibility of further medical treatment or surgery.
Latest Updates
- October 3, 2011 – FDA posted a Class 2 recall for the Cochlear Nucleus CI512 Cochlear Implant, part number Z209051, after the firm initiated the recall on September 16, 2011. FDA stated the implant may shut down and cease to function, identified the cause as a component design/selection issue, and listed 33,645 units in commerce globally, including 25,516 already implanted and 1,741 remaining in the U.S. market for implantation. [1]
Product Identification
This recall involved the Cochlear Nucleus CI512 Cochlear Implant, reference number Z209051. The FDA record describes it as a sterile implant made in Australia and intended to restore a level of auditory sensation through electrical stimulation of the auditory nerve.
The recall record listed all codes for part number Z209051. Anyone evaluating a possible claim should gather implant records, operative reports, device identification cards, audiology records, and any correspondence from Cochlear or the implanting clinic. In cases involving implanted devices, product identification usually begins with the patient’s medical file rather than retail packaging.
Scope of the Recall
The FDA database lists 33,645 units in commerce worldwide. Of those, 25,516 had already been implanted, and 1,741 remained in the U.S. market for implantation at the time of the recall.
The distribution was worldwide, including the United States, Europe, and Australia. That broad distribution matters because it shows the recall was not limited to a small shipment or isolated lot.
What Clinics and Patients Were Told
Cochlear Americas sent an urgent medical device recall letter to affected customers on September 16, 2011. The notice instructed customers to examine their inventory, quarantine affected product, and complete and return a recall response form.
For patients who had already received one of these implants, the real concern was whether the device would continue functioning normally over time. If a failure occurred, the medical and personal consequences could be significant.
Do You Qualify for a Cochlear Americas Implant Lawsuit?
A legal review may be appropriate if you received a recalled Cochlear Nucleus CI512 implant and later experienced shutdown, device failure, loss of hearing benefit, revision surgery, or other measurable harm. Claims are often stronger when the recalled implant can be clearly identified and the failure is documented through medical records and follow-up treatment notes.
Evidence to Gather
- Operative reports and implant records
- Device identification card or implant serial documentation
- Audiology and follow-up records
- Records of revision surgery or replacement procedures
- Correspondence from Cochlear, the hospital, or the implanting clinic
Potential Damages
Potential damages may include medical expenses, revision surgery costs, lost income, pain and suffering, and other documented losses tied to an implant failure.
References
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104183