PlainRecordsBrand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog…
Due to incorrect shelf-life expiration date.
Filed by: Advanced Bionics, LLC · Also listed under Advanced Bionics
By device type
Implant, Cochlear: device recalls
FDA device recalls whose record carries FDA's device name “Implant, Cochlear”: 32 records; the 20 recalls led by one, newest first. The name is FDA's classification, as written in the record.
Recent recalls
3 of 20Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number…
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.
Filed by: Advanced Bionics, LLC · Also listed under Advanced Bionics
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number…
Behind-the-ear sound processer packaging label is different then included product.
Filed by: Advanced Bionics, LLC · Also listed under Advanced Bionics
More recalls
17 in all years- May 28, 2025HiResolution" Bionic Ear System…Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. Recall began March 5, 2025
- July 24, 2024Mi1250 SYNCHRONY 2…A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional… Recall began April 18, 2024
- Dec. 2, 2020AB PowerCel 230 (velvet black)… and 1 more productMislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. Recall began Sept. 26, 2020
- May 27, 2020AB HiResolution Bionic Ear System… and 1 more producthearing performance degradation due to body-fluid entering the device. Recall began Feb. 17, 2020
- March 11, 2020SoundWave Professional Suite Software 3.2…The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message… Recall began April 4, 2019
- Feb. 26, 2020HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04…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… Recall began March 18, 2019
- April 10, 2019Nada CL Q30 Sound Processor… and 2 more productsThe sound processors were loaded with the incorrect firmware. Recall began Feb. 6, 2019
- July 29, 2015Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear” Nucleus Sterile Silicone Template is…Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. Recall began June 5, 2015
- Oct. 31, 2012HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear…Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies. Recall began Sept. 14, 2007
- Oct. 3, 2011Cochlear Nucleus CI512 Cochlear Implant…Cochlear implant may shut down and cease to function.
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- Dec. 21, 2010Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted… and 1 more productThe recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These…
- Nov. 2, 2009Nucleus Non-Magnetic Plug for removable magnet implants…Cochlear implant device component was mis-labeled. Recall began Sept. 30, 2009
- Sept. 11, 2009Advanced Bionics HiRes 90K Cochlear Implant…The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are… Recall began June 10, 2009
- Feb. 3, 2009HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED… and 3 more productsMistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007… Recall began July 24, 2008
- April 11, 2006The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS)… and 1 more productCertain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed… Recall began March 8, 2006
- Oct. 23, 2004Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models… and 2 more productsAll unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the…
- Aug. 10, 2004Auria PowerPak…Battery pack may overheat and cause patient burns.
No recalls match.
Reports to FDA about this kind of device
From Nov. 13, 2021 to Nov. 4, 2026, FDA's adverse event database (MAUDE) received 27,557 reports for Implant, Cochlear (FDA product code MCM): 10 reporting a death; 15,115 an injury; 12,431 a malfunction.
Problems named most in the reports:
Mechanical Problem 5,629Appropriate Device Problem Term/Code Not Available 5,250Adverse Event Without Identified Device or Use Problem 4,630Impedance Problem 4,368Expulsion 2,219Migration 1,824
Reports come from manufacturers, hospitals, doctors and patients. FDA does not confirm that a device caused an event, a malfunction report may involve no harm, and a count follows how many devices are in use. Counts as returned by openFDA's device adverse event service; in FDA's words, do not rely on openFDA to make decisions regarding medical care. Talk to your doctor about a device you use.