FDA
Advanced Bionics implantable cochlear stimulator CLARION 1.2
Models
AB-5100L
AB-5100R
AB-5100ML/R (For Export Only)
AB-5100H
AB-5100H-01A
All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.