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Terminated

Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02

FDA Recall Z-0046-05 · Posted 2004-10-23

Recalling FirmAdvanced Bionics
Recall StatusTerminated
Product CodeMCM
Date Initiated2004-09-27
Date Terminated2005-07-13
Product Quantity46 units

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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