Recall Z-0046-05 ยท MCM Implant, Cochlear
Advanced Bionics
Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02
| Date | Oct 23, 2004 (initiated Sep 27, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 46 units |
| Distribution | U.S. and Canada and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.