Cochlear Nucleus Nexa implant recalled for incomplete electrode welds
Cochlear Limited is recalling four Nucleus Nexa cochlear implants with Contour Advance electrodes (model CI1000) distributed in New Jersey, New York and Pennsylvania. A manufacturing deviation caused incomplete electrode welds, resulting in one or more open circuits. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Do not stop using your implant on your own; contact your care team and Cochlear first.
- Check whether your implant is model CI1000, catalog P1979576, UDI-DI 9321502069847, with serial number 1020210051972, 1020210070461, 1020210145046 or 1020210048286.
- The notice doesn't say what remedy is offered; ask Cochlear or your care team.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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. 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.
- Sold in
- U.S.: NJ, NY, and PA. O.U.S.: Not provided
- Made for
- All ages
Details
- Units affected
- 4 device in the U.S.
- Illnesses reported
- None reported
- Manufactured in
- 1 University Ave, Macquarie University, Australia
- Classification
- Class II
- Recall number
- Z-0349-2027
In the FDA's words
- 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. Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits 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 Affected quantity: 4 device in the U.S.
- Hazard
- Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits