Recall Z-0349-2027 ยท MCM Implant, Cochlear
Cochlear Limited
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 electr
| Date | Nov 3, 2026 (initiated Sep 30, 2026) |
| Status | Open, Classified |
| 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 |
| 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. |
| Quantity | 4 device in the U.S. |
| Distribution | U.S.: NJ, NY, and PA. O.U.S.: Not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.