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Advanced Bionics

Last updated May 23, 2026

Information

Country: US
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Catalogue (1669)

Page 12 of 34

Device	Model / Reference	Registries	Class	Status
Neptune™ Cable for UHP	CI-5413-304	FDA UDI	Class III	Unknown
Sky CI™ M90 Sound Processor	CI-5295-140	FDA UDI	Class III	Unknown
Naida CI Q90 Acoustic Earhook	CI-5850-010	FDA UDI	Class III	Active
RF Cable	CI-5415-602	FDA UDI	Class III	Unknown
M Standard battery	CI-5555-190	FDA UDI	Class III	Unknown
M Zn-Air Battery Pak	CI-5501-140	FDA UDI	Class III	Unknown
Naida CI Q70	CI-5245-170	FDA UDI	Class III	Unknown
HiFocus Mid-Scala Electrode Instrument Kit	CI-4508	FDA UDI	Class III	Active
AquaMic™ 3D Color Cap	CI-7130-340	FDA UDI	Class III	Active
Naida CI AquaCase	CI-7431	FDA UDI	Class III	Active
UHP Color Cap	CI-7125-LIM	FDA UDI	Class III	Unknown
Helix Electrode Instrument Kit	CI-4501	FDA UDI	Class III	Unknown
UHP 3D Color Cap	CI-7129-350	FDA UDI	Class III	Unknown
UHP 3D Color Cap	CI-7129-330	FDA UDI	Class III	Unknown
UHP 2.0 Color Cap	CI-7128-360	FDA UDI	Class III	Unknown
Slim HP Standard Magnet	CI-7524-005	FDA UDI	Class III	Unknown
PowerCel™ 170 Mini	CI-5527-110	FDA UDI	Class III	Active
Sky CI™ M90	CI-5295	FDA UDI	Class III	Active
RF Cable	CI-5415-506	FDA UDI	Class III	Active
UHP Color Cap	CI-7125-330	FDA UDI	Class III	Active
Auria™ PowerCel™ Slim	CI-5520-100	FDA UDI	Class III	Unknown
AIM™ System	CI-6126	FDA UDI	Class III	Active
UHP 2.0 Color Cap	CI-7128-110	FDA UDI	Class III	Active
Sky CI™ M90 Sound Processor	CI-5295-140	FDA UDI	Class III	Active
Sky CI™ M90 Sound Processor	CI-5295-260	FDA UDI	Class III	Unknown
PowerCel™ 110 Mini	CI-5521-220	FDA UDI	Class III	Active
AIM™ Insert Earphone	CI-6129	FDA UDI	Class III	Active
Headpiece Cable Right Angle	MMT-5405R	FDA UDI	Class III	Unknown
PowerCel™ 110	CI-5511-200	FDA UDI	Class III	Unknown
Auria™ T-Mic™	CI-5830-100	FDA UDI	Class III	Unknown
T-Mic™ 2	CI-5835-300	FDA UDI	Class III	Unknown
M Battery	CI-5551-260	FDA UDI	Class III	Active
PowerCel™ 230	CI-5523-110	FDA UDI	Class III	Unknown
PowerCel™ 230	CI-5523-130	FDA UDI	Class III	Unknown
Sky CI™ M90 Sound Processor	CI-5295-150	FDA UDI	Class III	Active
SoundWave™ Professional Suite Software	CI-6055-011	FDA UDI	Class III	Unknown
RF Cable	CI-5415-401	FDA UDI	Class III	Unknown
HiRes™ Ultra Coil Gauge	CI-4341	FDA UDI	Class III	Unknown
Neptune™ Cable for UHP	CI-5413-402	FDA UDI	Class III	Active
M Battery	CI-5551-190	FDA UDI	Class III	Unknown
M Battery	CI-5552-240	FDA UDI	Class III	Active
HiRes 90K™ Surgical Tool Kit	CI-4500	FDA UDI	Class III	Unknown
HiRes™ Ultra Magnet Insertion Tool	CI-4348	FDA UDI	Class III	Active
M Earhook	CI-5711-210	FDA UDI	Class III	Unknown
Neptune™ Covers	CI-7126-DBL	FDA UDI	Class III	Unknown
Sky CI™ M90	CI-5295	FDA UDI	Class III	Active
UHP Cable BTE	CI-5410-104	FDA UDI	Class III	Active
Neptune™ Cable for UHP	CI-5413-505	FDA UDI	Class III	Active
Zn-Air Battery Pak	CI-5500-240	FDA UDI	Class III	Active
Slim HP Color Cap	CI-7132-002	FDA UDI	Class III	Active

Related Companies

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FDA Recalls (28)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 30, 2026	Z-2283-2026	—	open, classified	Due to incorrect shelf-life expiration date.
Mar 23, 2026	Z-1950-2026	—	open, classified	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.
Nov 27, 2025	Z-1493-2026	—	open, classified	Behind-the-ear sound processer packaging label is different then included product.
Mar 5, 2025	Z-1813-2025	—	open, classified	Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Sep 26, 2020	Z-0486-2021	—	terminated	Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Sep 26, 2020	Z-0487-2021	—	terminated	Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Feb 17, 2020	Z-2033-2020	—	terminated	hearing performance degradation due to body-fluid entering the device.
Feb 17, 2020	Z-2032-2020	—	terminated	hearing performance degradation due to body-fluid entering the device.
Apr 4, 2019	Z-1441-2020	—	terminated	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 installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.
Mar 18, 2019	Z-1259-2020	—	terminated	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 Agency (PMDA) of Japan.
Feb 6, 2019	Z-1083-2019	—	terminated	The sound processors were loaded with the incorrect firmware.
Feb 6, 2019	Z-1085-2019	—	terminated	The sound processors were loaded with the incorrect firmware.
Feb 6, 2019	Z-1084-2019	—	terminated	The sound processors were loaded with the incorrect firmware.
Jun 10, 2009	Z-2039-2009	—	terminated	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 related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas
Sep 22, 2008	Z-0271-2009	—	terminated	Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on
Jul 24, 2008	Z-0958-2009	—	terminated	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 through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can
Jul 24, 2008	Z-0956-2009	—	terminated	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 through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann
Jul 24, 2008	Z-0957-2009	—	terminated	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 through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can
Jul 24, 2008	Z-0959-2009	—	terminated	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 through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann
Oct 5, 2007	Z-0960-2008	—	terminated	Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t
Oct 5, 2007	Z-0961-2008	—	terminated	Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t
Aug 3, 2007	Z-0055-2008	—	terminated	Mislabeled: Product labeled with the incorrect shelf-life information.
Jan 30, 2007	Z-0700-2007	—	terminated	The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
Nov 11, 2004	Z-0396-05	—	terminated	A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
Sep 27, 2004	Z-0045-05	—	terminated	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.
Sep 27, 2004	Z-0044-05	—	terminated	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.
Sep 27, 2004	Z-0046-05	—	terminated	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.
Jul 27, 2004	Z-1332-04	—	terminated	Battery pack may overheat and cause patient burns.