# P960058: Clarion Multi-Strategy Cochlear Implant

- Pathway: PMA
- Applicant: Advanced Bionics
- Decided: Jun 26, 1997 after 178 days
- Product code: MCM (Implant, Cochlear)
- Device class: 3
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 30, 2026 · Class II · Z-2283-2026: Due to incorrect shelf-life expiration date.
- Mar 23, 2026 · Class II · Z-1950-2026: The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
- Mar 5, 2025 · Class II · Z-1813-2025: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
- Feb 17, 2020 · Class II · Z-2033-2020: hearing performance degradation due to body-fluid entering the device.
- Feb 17, 2020 · Class II · Z-2032-2020: hearing performance degradation due to body-fluid entering the device.
- Apr 4, 2019 · Class III · Z-1441-2020: The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed ins
- Mar 18, 2019 · Class III · Z-1259-2020: Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices 
- Feb 6, 2019 · Class II · Z-1085-2019: The sound processors were loaded with the incorrect firmware.
- Feb 6, 2019 · Class II · Z-1084-2019: The sound processors were loaded with the incorrect firmware.
- Feb 6, 2019 · Class II · Z-1083-2019: The sound processors were loaded with the incorrect firmware.
- Jun 10, 2009 · Not classified · Z-2039-2009: The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue relate
- Jul 24, 2008 · Not classified · Z-0956-2009: Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process t
- Jul 24, 2008 · Not classified · Z-0958-2009: Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process t
- Jul 24, 2008 · Not classified · Z-0959-2009: Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process t
- Jul 24, 2008 · Not classified · Z-0957-2009: Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process t
- Mar 8, 2006 · Not classified · Z-0759-06: Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for sig
- Mar 8, 2006 · Not classified · Z-0758-06: Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for sig

Source page: https://510kreport.com/device/P960058
Methodology: https://510kreport.com/methodology