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Advanced Bionics

Active in EUDAMED

Registered as Advanced Bionics LLC in EUDAMED

Also registered as Advanced Bionics AG, Advanced Bionics Corp., Advanced Bionics Corporation, Advanced Bionics LLC

United Statesfrom SRN EUDAMED SRN US-MF-000019344

Devices
2,104
Registrations
EUDAMED
FDA recalls
354 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

5 of 5 in force.

See certificates

Market reach

European Union
EUDAMED actor, 5 certificates
United States
FDA recalls

What Advanced Bionics makes

Advanced Bionics makes cochlear implant systems and rechargeable battery packs.

Its devices are listed in EUDAMED (the European database on medical devices) and the FDA GUDID device identification database. Device classes on record: EU Class III; FDA Class III.

AI-generated from registry data, 11 Nov 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2,104

Newest first, rows 1-50 of 2,104

Search and filter all 2,104 devices
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  • PowerCel™ 110 Mini CI-5521-120 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-130 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-140 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-150 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-230 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-160 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-240 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-120 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-170 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-130 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-240 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-140 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-140 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-120 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-150 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-130 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-150 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-170 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-160 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-190 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-110 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-160 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-220 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-170 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-110 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-230 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 Mini CI-5521-190 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-190 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-110 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-140 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-120 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 Mini CI-5527-220 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-150 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 110 CI-5511-220 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-170 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-130 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-160 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-110 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-190 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 170 CI-5517-220 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-120 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-150 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-140 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-160 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-130 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-170 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-190 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-220 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • PowerCel™ 230 CI-5523-110 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • M Standard Battery CI-5555-260 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

Rows 1-50 of 2,104

Showing 1-50 of 2,104

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000019344
EUDAMED status
Active
EUDAMED registered name
Advanced Bionics LLC
Registered address
28515, Westinghouse Place, CA 91355, Valencia, United States
PRRC contact
Michelle Caulfield(public in EUDAMED)

EUDAMED certificates5

5 certificates5 valid, 0 expiredMDR 5next expiry 21 Sep 2027

EUDAMED certificates (5)

TÜV SÜD Product Service GmbH 0123 5 certificates

  • G70 077725 0042 Active

    Technical documentation EU MDR

    Issued
    2 Sep 2026
    Expires
    1 Sep 2031
  • G70 077725 0043 Active

    Technical documentation EU MDR

    Issued
    2 Sep 2026
    Expires
    1 Sep 2031
  • G70 077725 0022 Active Supplemented

    Technical documentation EU MDR

    Issued
    9 Jul 2026
    Expires
    14 Apr 2031
    Reason
    Add device or group
  • G70 077725 0027 Active Supplemented

    Technical documentation EU MDR

    Issued
    2 Sep 2026
    Expires
    6 Feb 2029
    Reason
    Add device or group
  • G70 077725 0026 Expiring Supplemented Expires in 314 days

    Technical documentation EU MDR

    Issued
    29 Jun 2026
    Expires
    21 Sep 2027
    Reason
    Add device or group

FDA recalls35

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 5
  • 2020 4
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 2
  • 2026 2

22 initiated before 2017

Showing the 10 most recent of 35 recalls.

  • 2026

    • 30 Apr 2026 Z-2283-2026 Class II Ongoing Due to incorrect shelf-life expiration date. Distribution: U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI. Submission number: P960058
    • 23 Mar 2026 Z-1950-2026 Class II Ongoing 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. Distribution: Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Chile, Croatia, Cuba, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
      Submission number: P960058

  • 2025

    • 27 Nov 2025 Z-1493-2026 Class II Ongoing Behind-the-ear sound processer packaging label is different then included product. Distribution: Unknown Submission number: P960058S149
    • 5 Mar 2025 Z-1813-2025 Class II Ongoing Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. Distribution: U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A Submission number: P960058

  • 2020

    • 26 Sep 2020 Z-0486-2021 Class III Terminated Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.
    • 26 Sep 2020 Z-0487-2021 Class III Terminated Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.
    • 17 Feb 2020 Z-2032-2020 Class II Terminated hearing performance degradation due to body-fluid entering the device. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China,…
      Full distribution text Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020
      Submission number: P960058
    • 17 Feb 2020 Z-2033-2020 Class II Terminated hearing performance degradation due to body-fluid entering the device. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China,…
      Full distribution text Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020
      Submission number: P960058

  • 2019

    • 4 Apr 2019 Z-1441-2020 Class III 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. Distribution: US Nationwide distribution in the sates of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI,…
      Full distribution text US Nationwide distribution in the sates of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI
      Submission number: P960058
    • 18 Mar 2019 Z-1259-2020 Class III 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. Distribution: No US distribution OUS: Japan Submission number: P960058
Show the 25 most recent of 35 recalls

  • 2019

    • 6 Feb 2019 Z-1083-2019 Class II Terminated The sound processors were loaded with the incorrect firmware. Distribution: Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait,…
      Full distribution text Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
      Submission number: P960058
    • 6 Feb 2019 Z-1084-2019 Class II Terminated The sound processors were loaded with the incorrect firmware. Distribution: Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait,…
      Full distribution text Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
      Submission number: P960058
    • 6 Feb 2019 Z-1085-2019 Class II Terminated The sound processors were loaded with the incorrect firmware. Distribution: Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait,…
      Full distribution text Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
      Submission number: P960058

  • 2010

    • 23 Nov 2010 Z-0795-2011 Unclassified (pre-2012) Terminated The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device. Distribution: Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ,…
      Full distribution text Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.
      Submission number: P960058S030
    • 23 Nov 2010 Z-0796-2011 Unclassified (pre-2012) Terminated The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device. Distribution: Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ,…
      Full distribution text Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.
      Submission number: P960058S030

  • 2009

    • 10 Jun 2009 Z-2039-2009 Unclassified (pre-2012) 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 Distribution: Worldwide Distribution -- US, Canada, France and South Korea. Submission number: P960058

  • 2008

    • 22 Sep 2008 Z-0271-2009 Unclassified (pre-2012) 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 Distribution: Nationwide and Internationally - Ireland, Korea, Mexico, The Netherlands, United Kingdom, Canada, Australia and Israel Submission number: P030017
    • 24 Jul 2008 Z-0956-2009 Unclassified (pre-2012) 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 Distribution: Nationwide Submission number: P960058
    • 24 Jul 2008 Z-0957-2009 Unclassified (pre-2012) 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 Distribution: Nationwide Submission number: P960058
    • 24 Jul 2008 Z-0958-2009 Unclassified (pre-2012) 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 Distribution: Nationwide Submission number: P960058
    • 24 Jul 2008 Z-0959-2009 Unclassified (pre-2012) 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 Distribution: Nationwide Submission number: P960058
    • 22 Apr 2008 Z-1441-2012 Unclassified (pre-2012) Terminated The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual. Distribution: Worldwide Distribution including Great Britian Submission number: P030017

  • 2007

    • 5 Oct 2007 Z-0960-2008 Unclassified (pre-2012) 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 Distribution: Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel. Submission number: P030017
    • 5 Oct 2007 Z-0961-2008 Unclassified (pre-2012) 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 Distribution: Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.
    • 14 Sep 2007 Z-0117-2013 Class II Terminated Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies. Distribution: Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.

Frequently asked questions

How many devices does Advanced Bionics have in the registry?

The registry currently lists 2104 devices for Advanced Bionics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Advanced Bionics's devices?

Among its 50 most recently registered devices, Advanced Bionics has devices listed in FDA GUDID (50 devices).

What risk classes do Advanced Bionics's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Advanced Bionics's devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Advanced Bionics?

FDA recall records list 35 recalls initiated by Advanced Bionics, the most recent initiated on 30 Apr 2026. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Advanced Bionics?

EUDAMED lists 5 certificates for Advanced Bionics (technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 2 Sep 2026.

What are the newest devices from Advanced Bionics in the registry?

The most recently registered devices listed for Advanced Bionics include PowerCel™ 110 Mini CI-5521-120, PowerCel™ 110 Mini CI-5521-130, PowerCel™ 110 Mini CI-5521-140 and PowerCel™ 110 Mini CI-5521-150.

Generated automatically from registry data and not verified by a human reviewer.