Cochlear Americas Implant Recall Lawsuit | 2026 Latest Updates

Cochlear Americas Inc. recalled the Cochlear Nucleus CI512 Cochlear Implant, part number Z209051, because the device may shut down and stop working. The FDA classified it as a Class 2 recall. The recall covers about 33,645 implants worldwide, including roughly 25,516 already implanted and 1,741 still awaiting implantation in the United States. Cochlear initiated the recall September 16, 2011, and the FDA posted it October 3, 2011. The FDA traced the failures to a component design and selection defect. Affected clinics were told to quarantine any inventory and return a recall response form. The recall’s status is terminated as of July 10, 2012.

Latest Cochlear Americas Implant Recall Updates

September 26, 2014: Federal Court Rules on Tansey Implant Case

A federal court in the Eastern District of New York ruled in Tansey v. Cochlear Limited, a product-liability lawsuit over a recalled Cochlear Nucleus CI512 implant [1]. Jeanine Tansey brought the case against Cochlear Limited and Cochlear Americas over the recalled implant, docketed as a diversity-jurisdiction personal-injury and product-liability claim under 28 U.S.C. 1332. No further court record or settlement was found after the 2014 opinion.

July 25, 2014: Federal Court Rules on Thibodeau Implant Case

In Thibodeau v. Cochlear Limited, a federal court in the District of Arizona ruled on a second individual lawsuit tied to the same recalled implant model [2]. Justin Thibodeau named Cochlear Limited and Cochlear Americas as defendants in that suit, also filed on diversity grounds as a product-liability claim. No further filing or settlement has surfaced since the 2014 opinion.

July 10, 2012: FDA Lists the Cochlear Recall as Terminated

The FDA listed the Cochlear Nucleus CI512 recall as terminated on July 10, 2012, closing the Class 2 action it had posted on October 3, 2011 [3]. FDA policy allows a recall’s cause finding to be modified at any time up to the point of termination, and the record lists this action as Recall Number Z-0003-2012, FDA Recall Event ID 59979.

April 23, 2012: Class Action Reported over Nucleus CI500-Range Implants

Courthouse News reported that Wyly Wade filed a proposed class action against Cochlear Limited over Nucleus CI500-range implant failures [4]. He filed it about six months after the FDA’s own recall of the CI512 model. His young daughter’s implants had failed and were surgically removed about a month before the FDA’s recall. The suit sought class damages, including medical monitoring, for implants that could shut down and stop functioning without warning.

January 31, 2012: Cochlear Details the Cause of Implant Failures

Cochlear Limited CEO Chris Roberts described the cause in letters quoted in the Wade complaint. Variations in the brazing process left some implants prone to microcracks that let water reach internal electronic components. A follow-up letter, quoted in the same complaint, gave a global count. By January 31, 2012, 2.4 percent of registered Nucleus CI500-series devices had been reported as failed, months after the FDA’s own recall began.

October 3, 2011: FDA Posts the Class 2 Recall

Cochlear Americas initiated the recall on September 16, 2011, sending affected customers an urgent recall letter that described the product and the problem. The FDA posted the Class 2 action on October 3, 2011. The notice covered Cochlear Nucleus CI512 implants bearing part number Z209051, made in Australia by Cochlear Ltd. and distributed worldwide, across the United States, Europe, and Australia.

Which Cochlear Americas Implants Are Affected?

The recall affects a single cochlear implant model, identified by the markings on the implant’s identification card or in a patient’s audiology records:

• The Cochlear Nucleus CI512 Cochlear Implant, the only model covered by this recall notice
• Part or REF number Z209051, covering all lot and date codes Cochlear issued under this part number
• PMA number P970051, the FDA’s premarket-approval number for this implant

Because this is a surgically implanted device rather than a retail product, patients cannot check a store receipt or packaging for the recall notice. Cochlear Americas mailed identification details directly to the implanting clinics, which hold patient-specific records tied to each device’s part number and manufacturing codes. A patient unsure whether their implant is the recalled Cochlear Nucleus CI512 should ask their implant center to confirm it. The center can check the part number on file rather than relying on memory alone.

Why Were the Cochlear Americas Implants Recalled?

The Cochlear Nucleus CI512 implant was recalled because it may shut down and cease to function, a failure the FDA traced to component design and selection. Cochlear’s own investigation, described in CEO Chris Roberts’ letters, pointed to the manufacturing process. Variations in the brazing step left a limited number of devices prone to developing microcracks later on. Those microcracks let water molecules reach the implant’s internal electronic components, causing the malfunction. The brazing process joins the implant’s external and internal parts and must stay watertight for the device to keep working. Cochlear Americas mailed clinics a recall letter describing the defect on September 16, 2011, and the FDA classified the action as a Class 2 recall after its review.

Reported Incidents, Injuries, or Illnesses

The FDA’s official recall record does not itself publish a separate count of injury or incident reports tied to this recall. Cochlear’s own CEO letters, quoted in a federal complaint and detailed in the January 31, 2012 update above, reported a 2.4 percent global failure rate instead. Reports of a device failure describe what patients or clinics observed. They are not a finding that every implant will fail or that a given patient’s hearing loss has one confirmed cause. Anyone who believes their implant failed, or who noticed reduced hearing performance after receiving a Cochlear Nucleus CI512 implant, should discuss the device’s status with their implant center.

What Should Consumers Do?

Anyone with a Cochlear Nucleus CI512 implant, or a clinic that still has unimplanted units on hand, should take the following steps:

1. Check the implant’s part number against REF Z209051 on the patient’s identification card or the clinic’s inventory records.
2. Clinics should quarantine any unimplanted units still on hand and stop distributing them.
3. Complete and return the recall response form Cochlear Americas mailed with its recall letter.
4. Contact Cochlear Clinic Customer Service at 877-883-3101 with questions about the recall notice.
5. Patients whose implant appears to stop working should contact their implant center or audiologist promptly.
6. Report a suspected device problem to the FDA’s MedWatch program at 1-800-FDA-1088.

Other Recalls, Warnings, or International Actions

Australia’s Therapeutic Goods Administration issued a Class II hospital-level recall on September 13, 2011 (Reference RC-2011-RN-00920-3), covering the wider Cochlear Nucleus CI500 implant range [5]. The action named four devices: the CI512 (Part Z209051), the CI513 (Part Z110048), the ABI541 Auditory Brainstem Implant (Part Z246604), and the CI551 Double Array (Part Z246605).

Legal Options

No multidistrict litigation or class-wide settlement covers the Cochlear Nucleus CI512 recall, according to the federal courts’ pending-MDL docket [6]. Individual product-liability suits (Tansey v. Cochlear Limited and Thibodeau v. Cochlear Limited) and one 2012 putative class action, Wade v. Cochlear Limited, are the only litigation found over this device. A recall does not automatically establish liability or eligibility for compensation. Anyone who believes a recalled implant caused an injury may want a lawyer’s review of their specific facts and timeline.

Filing Deadlines

State law sets the deadlines for bringing a legal claim over a recalled medical device, separate from any federal recall rule or notice. These deadlines vary with where a person lives and with when an injury and its diagnosis happened. Some states start the clock at diagnosis rather than at the original surgery. Missing a filing deadline can end a claim regardless of its underlying facts, so anyone considering a claim over a Cochlear implant should check with a lawyer promptly.

Frequently Asked Questions

Is the Cochlear Nucleus CI512 Recall Still Active?

No, the Cochlear Nucleus CI512 recall is not still active. The FDA lists Recall Z-0003-2012 as terminated on July 10, 2012, and no expansion, reannouncement, or new consumer alert about this device has followed in the years since.

What Caused the Cochlear Nucleus CI512 Implant to Fail?

The Cochlear Nucleus CI512 implant failed because of variations in Cochlear’s brazing process, which let water molecules reach internal electronic components, Cochlear’s own letters said. Using its reported 2.4 percent failure rate, the underlying lawsuit calculated that about 612 of the 25,516 implanted devices could be affected.

Is There a Class Action Lawsuit over the Cochlear Nucleus CI512 Implant?

Yes, one putative class action has been reported over the Cochlear Nucleus CI512 implant: Wade v. Cochlear Limited, filed in Chicago federal court and litigated by attorney Scott Morgan of Scott Morgan & Associates. No class was certified in the record found.

Were Individual Lawsuits Filed over Cochlear Implant Failures?

Yes, individual lawsuits were filed over Cochlear implant failures: Tansey v. Cochlear Limited (No. 13-cv-4628, Eastern District of New York) and Thibodeau v. Cochlear Limited (No. 13-cv-2184, District of Arizona), both docketed as product-liability suits with federal court opinions recorded in 2014.

Was the Cochlear Implant Recall Limited to the United States?

No, the recall was not limited to the United States. Australia’s TGA separately estimated in September 2011 that fewer than 1 percent of the recalled implants had failed. Cochlear’s own letters later raised the reported global failure rate to 2.4 percent.

Was the Australian Recall Broader than the CI512 Implant?

Yes, the Australian recall was broader than the CI512 implant. A related TGA action covered several implants in the same family, and Australia’s Special Access Scheme was the only way patients could access two of them, unlike the FDA’s CI512-only U.S. recall.

References

1. https://www.govinfo.gov/app/details/USCOURTS-nyed-2_13-cv-04628
2. https://www.govinfo.gov/app/details/USCOURTS-azd-2_13-cv-02184
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104183
4. https://www.courthousenews.com/class-claims-cochlear-implants-fail/
5. https://web.archive.org/web/20251114004515/https://www.tga.gov.au/safety/recalls-and-other-market-actions/market-actions/cochlear-nucleus-ci500-implant-range-recall-notice
6. https://www.jpml.uscourts.gov/pending-mdls-0