Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000 UDI-DI codes: 9321502069847 Cochlea…
Cochlear Limited · Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits
Open FDA's page for this record- Cfres ID
- 223302
- Product res number
- Z-0349-2027
- Event date initiated
- 2026-09-30
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 100098
- Product code
- MCM
- Code info
- Model: CI1000 Product/Catalog: P1979576 UDI-DI code: 9321502069847 Serial Numbers: 1020210051972 1020210070461 1020210145046 1020210048286
- Firm FEI number
- 3009092818
- Recalling firm
- Cochlear Limited
- Address 1
- 1 University Ave
- City
- Macquarie University
- Country
- Australia
- Additional info contact
- Laura Blair 720-301-1034
- Reason for recall
- Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits
- Root cause description
- Under Investigation by firm
- Product quantity
- 4 device in the U.S.
- Distribution pattern
- U.S.: NJ, NY, and PA. O.U.S.: Not provided
- Product description
Cochlear 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.
- Action
On 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.
- PMA numbers
- P970051S225
- Harmonized identifiers (openFDA)
- Device name
- Implant, Cochlear
- Medical specialty description
- Unknown
- Device class
- 3
- PMA number
- P200021, P940022, P830069, P970051, P000025, P890027, P840024, P000015, P960058
- Registration number
- 3011823740, 9611813, 2030624, 3009092818, 3012654499, 3010363503, 8043792, 3030784382, 3005210579, 9710014, 3033788852, 3034170504, 3007743836, 3002808022, 3008947133, 3014579188, 3020283264, 3005900820, 3002806740, 1721676, 3013177549, 3009762645, 9613646
- FEI number
- 3011823740, 3003045432, 3009092818, 3012654499, 3010363503, 3030784382, 3002808269, 3005210579, 3033788852, 3034170504, 3007743836, 3002808022, 3008947133, 3014579188, 3020283264, 3005900820, 1000220815, 3002806740, 3000249315, 1721676, 3000206435, 3013177549, 3002806685