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Terminated

Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

FDA Recall Z-0044-05 · Posted 2004-10-23

Recalling FirmAdvanced Bionics
Recall StatusTerminated
Product CodeMCM
Date Initiated2004-09-27
Date Terminated2005-07-13

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.

Firm 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.

Root Cause

Other

Distribution Pattern

U.S. and Canada and France

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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