Z-0045-05

Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A

Name: Z-0045-05 Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A
Creator: Advanced Bionics
Published: 2004-09-27
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2004-09-27 / Terminated

FDA source

Advanced Bionics began a recall of Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A on 2004-09-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0045-05
Status: Terminated
Initiated: 2004-09-27
Posted: 2004-10-23
Terminated: 2005-07-13
Recalling firm: Advanced Bionics LLC
Product: Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A
Product code: MCM Implant, Cochlear
Reason for recall: 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.
FDA 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.
Distribution: U.S. and Canada and France
Product codes and lots: Unimplanted CLARION CII

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)