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U.S. Department of Health and Human Services

Class 2 Device Recall Cochlear Nucleus CI1000 Series

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 Class 2 Device Recall Cochlear Nucleus CI1000 Seriessee related information
Date Initiated by FirmSeptember 30, 2026
Date PostedNovember 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0349-2027
Recall Event ID 100098
PMA NumberP970051S225 
Product Classification Implant, cochlear - Product Code MCM
ProductCochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000 UDI-DI codes: 9321502069847 Cochlear Nucleus CI1000 Series implants are prescription only, single use devices intended for long term implantation under the skin in the mastoid region on either side of the head. The cochlear implant system works by converting sound in the environment into electrical code. It transmits this code to the auditory nerve and on to the brain where it is interpreted as sound. The Cochlear Implant System consists of internal (implanted) and external components. The implanted component consists of a receiver/stimulator and an electrode array. The external components consist of a sound processor and their associated transmitting coils and cables and must be worn for the implant to work.
Code Information Model: CI1000 Product/Catalog: P1979576 UDI-DI code: 9321502069847 Serial Numbers: 1020210051972 1020210070461 1020210145046 1020210048286
FEI Number 3009092818
Recalling Firm/
Manufacturer		 Cochlear Limited
1 University Ave
Macquarie University Australia
For Additional Information ContactLaura Blair
720-301-1034
Manufacturer Reason
for Recall		Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 09/30/2026, an "URGENT Field Safety Corrective Action Notification" was sent to U.S. customers informing them that a potential condition has been identified that could result in one or more open circuits affecting individual electrode pathways with the implant. Customers were instucted to not implant and return affected products to Cochlear Limited. For questions contact CNA_Quality@cochlear.com.
Quantity in Commerce4 device in the U.S.
DistributionU.S.: NJ, NY, and PA. O.U.S.: Not provided
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MCM
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