Device recall
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.
- Recall number
- Z-0349-2027
- Event id
- 100098
- Status
- Open, Classified
- FDA classification
- Class III
- Recalling firm
- Cochlear Limited
- Posted
- Nov 3, 2026
- Initiated
- Sep 30, 2026
- Product code
- MCM
- Device type
- Implant, Cochlear
- Reason
- Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits
- Root cause
- Under Investigation by firm
- Quantity
- 4 device in the U.S.
- Code info
- Model: CI1000 Product/Catalog: P1979576 UDI-DI code: 9321502069847 Serial Numbers: 1020210051972 1020210070461 1020210145046 1020210048286
- Distribution
- U.S.: NJ, NY, and PA. O.U.S.: Not provided
- Location
- Macquarie University, Australia