RF Cable CI-5415-305

• FDA PMA P960058 decided 26 Jun 1997 Active
• FDA GUDID UDI-DI 00840094404731 listed 13 Jan 2023 Listed

• • Ongoing Z-2283-2026 FDA Class II ·initiated 30 Apr 2026

  Due to incorrect shelf-life expiration date.

• • Ongoing Z-1950-2026 FDA Class II ·initiated 23 Mar 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.

• • Ongoing Z-1813-2025 FDA Class II ·initiated 5 Mar 2025

  Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

• 2 recalls, same reason

  • Terminated Z-2033-2020 FDA Class II ·initiated 17 Feb 2020
  • Terminated Z-2032-2020 FDA Class II ·initiated 17 Feb 2020

  hearing performance degradation due to body-fluid entering the device.

• • Terminated Z-1441-2020 FDA Class III ·initiated 4 Apr 2019

  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.

• • Terminated Z-1259-2020 FDA Class III ·initiated 18 Mar 2019

  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.

• 3 recalls, same reason

  • Terminated Z-1085-2019 FDA Class II ·initiated 6 Feb 2019
  • Terminated Z-1084-2019 FDA Class II ·initiated 6 Feb 2019
  • Terminated Z-1083-2019 FDA Class II ·initiated 6 Feb 2019

  The sound processors were loaded with the incorrect firmware.

• • Terminated Z-2039-2009 FDA Unclassified (pre-2012) ·initiated 10 Jun 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 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

• 2 recalls, same reason

  • Terminated Z-0957-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2008
  • Terminated Z-0958-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2008

  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

• 2 recalls, same reason

  • Terminated Z-0956-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2008
  • Terminated Z-0959-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2008

  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

• 2 recalls, same reason

  • Terminated Z-0759-06 FDA Unclassified (pre-2012) ·initiated 8 Mar 2006
  • Terminated Z-0758-06 FDA Unclassified (pre-2012) ·initiated 8 Mar 2006

  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 signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.

1. 6 Feb 2019 Recall initiated FDA recalls Z-1084-2019
2. 6 Feb 2019 Recall initiated FDA recalls Z-1083-2019
3. 18 Mar 2019 Recall initiated FDA recalls Z-1259-2020
4. 4 Apr 2019 Recall initiated FDA recalls Z-1441-2020
5. 17 Feb 2020 Recall initiated FDA recalls Z-2033-2020
6. 17 Feb 2020 Recall initiated FDA recalls Z-2032-2020
7. 13 Jan 2023 Listed FDA GUDID 00840094404731
8. 5 Mar 2025 Recall initiated FDA recalls Z-1813-2025
9. 23 Mar 2026 Recall initiated FDA recalls Z-1950-2026
10. 30 Apr 2026 Recall initiated FDA recalls Z-2283-2026

9 earlier events are in the sections above.

Trade name

RF Cable

Generic name

Cochlear implant/auditory brainstem implant external coil cable

Model / reference

CI-5415-305

Primary DI / UDI-DI

00840094404731

PMA number

P960058 ↗

FDA product code

MCM

GMDN term

Cochlear implant/auditory brainstem implant external coil cable

Device class

Class III

GUDID distribution status

In Commercial Distribution

Size

Length — 30 Centimeter

Category: Cochlear implant/auditory brainstem implant coil cable

• PowerCel™ 110 Mini CI-5521-120 Open recall

  Class III

  FDA PMA P960058 Active Approved 26 Jun 1997 GUDID on market

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

  Class III

  FDA PMA P960058 Active Approved 26 Jun 1997 GUDID on market

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

  Class III

  FDA PMA P960058 Active Approved 26 Jun 1997 GUDID on market

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

  Class III

  FDA PMA P960058 Active Approved 26 Jun 1997 GUDID on market

See all devices from Advanced Bionics →