Cochlear Limited: Implant, Cochlear
- Recalling firm
- Cochlear Limited
- Product
- 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....
- Reason
- Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-30
- Status
- Ongoing
- Areas affected
- NJ, NY, PA
- Distribution
- U.S.: NJ, NY, and PA. O.U.S.: Not provided
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8422703b-29da-4a30-974f-5234fc77b853