FDA Medical Device Recalls (openFDA)
Advanced Bionics: Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02
- Recall number
- Z-0046-05
- Recalling firm
- Advanced Bionics
- Product
- Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02
- Status
- Terminated
- Initiated
- 2004-09-27
- Posted
- 2004-10-23
- Terminated
- 2005-07-13
- 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
- Lot, serial or model codes
- HiRes 90K Implantable Cochlear Stimulator, Model Number CI-1400-01, manufactured prior to December 1, 2003.
- 510(k) numbers
- not on file
- PMA numbers
- ["P960058S030"]
- Product code
- MCM
- Firm FEI
- 1000220815
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28