FDA recall, , Moderate risk
Cochlear Nucleus Nexa Cochlear Implant with Contour Advance Electrode
Cochlear Nucleus Nexa cochlear implants have incomplete electrode welds, which can cause open circuits.
Summary by Recall Canary from the FDA notice
What happened
Cochlear Limited, based in Macquarie University, Australia, is voluntarily recalling the Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000. The recall is due to a manufacturing deviation of incomplete electrode welds, resulting in one or more open circuits.
The company began the recall on September 30, 2026, and the FDA added it to its Enforcement Report on November 3, 2026. The recall affects four devices in the U.S., distributed in New Jersey, New York, and Pennsylvania.
The Cochlear Nucleus CI1000 Series implants are prescription-only, single-use devices intended for long-term implantation under the skin in the mastoid region. The implant system converts sound into electrical code and transmits it to the auditory nerve. The affected devices were identified through the manufacturing deviation. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576
- Model
- CI1000
- UDI-DI
- 9321502069847
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
U.S.: New Jersey, New York, and Pennsylvania. O.U.S.: Not provided
- Recalled by
- Cochlear LimitedMacquarie University, Australia
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100098
- Recall number
- Z-0349-2027
- Quantity recalled
- 4 device in the U.S.
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Cochlear Limited
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Cochlear began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
