HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04 (UDI 07630016832185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 07630016832185), received between Jun 29, 2018 and Apr 13, 2026 — classified as 96 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (16 reports).

1 FDA recall record name this device's identifier.

16 other recalls cover devices cleared under the same FDA submission (P960058); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 18, 2019Class IIITerminated

   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.

   Z-1259-2020 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Device Dislodged or Dislocated

  THE RECIPIENT REPORTEDLY EXPERIENCED MAGNET DISPLACEMENT FOLLOWING AN MRI, DUE TO THE BANDAGE PROTOCOL NOT BEING FOLLOWED. THE MAGNET WAS SUCCESSFULLY REPOSITIONED THROUGH EXTERNAL MANIPULATION. THE RECIPIENT EXPERIENCED SOME PAIN, WHICH HAS SINCE RESOLVED, AND THE DEVICE IS NOW FUNCTIONING PROPERLY.

  Patient problems: Pain

  MAUDE report 24866561 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A CHOLESTEATOMA INFECTION AND REQUIRED SURGERY TO REMOVE THE INFECTED TISSUE. THE INFECTION REPORTEDLY REACHED THE IMPLANT, AND THE RECIPIENT'S DEVICE WAS EXPLANTED DUE TO INFECTION FROM CHOLESTEATOMA. THE RECIPIENT WAS IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Cholesteatoma

  MAUDE report 24437088 ↗
• MalfunctionNov 17, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577881 ↗
• MalfunctionOct 17, 2025Mechanical Problem; Impedance Problem; Mechanical Problem; Impedance Problem

  A REVIEW OF THE RECIPIENT'S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 23330240 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE SURGEON MISTAKENLY EXPLANTED THE WRONG DEVICE. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22531850 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A FLIPPED MAGNET FOLLOWING AN MRI. HEAD BANDAGING PROCEDURE WAS FOLLOWED. THE RECIPIENT HAS RESUMED DEVICE USE. REVISION SURGERY IN UNDER CONSIDERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22394649 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A HEAD TRAUMA EVENT. THE RECIPIENT REPORTEDLY RECEIVED STITCHES CLOSE TO THE IMPLANT SITE. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Head Injury

  MAUDE report 22372675 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED DUE TO THINNING OF THE SKIN CAUSED BY AN INFECTION. THE RECIPIENT WAS REPORTEDLY HOSPITALIZED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 22211257 ↗
• MalfunctionMay 22, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrostatic Discharge; Electrical /Electronic Property Problem; Mechanical Problem; Electrostatic Discharge

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND NO SOUND WITH DEVICE USE. DEVICE TESTING REVEALED ABNORMAL RESULTS. THE RECIPIENT IS UNABLE TO WEAR THE DEVICE DUE TO PAIN. EXTERNAL EQUIPMENT AND THE EXTERNAL MAGNET WERE EXCHANGED, AND PROGRAMMING ADJUSTMENTS WERE MADE: HOWEVER, THE ISSUES WERE NOT RESOLVED. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 22069663 ↗
• InjuryApr 4, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE RECIPIENT REPORTEDLY UNDERWENT AN MRI. BANDAGING PROTOCOL WAS FOLLOWED. THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND A DISLODGED MAGNET. THE RECIPIENT WAS ADVISED TO CEASE DEVICE USE. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Pain

  MAUDE report 21773074 ↗
• InjuryApr 2, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND LOSS OF LOCK. THE RECIPIENT REPORTEDLY WALKED INTO AN MRI SUITE AND EXPERIENCED PAIN. NO MRI WAS PERFORMED. MAGNET REPLACEMENT SURGERY HAS BEEN SCHEDULED.

  Patient problems: Pain

  MAUDE report 21751295 ↗
• InjuryJan 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, THE RECIPIENT REPORTEDLY UNDERWENT AND MRI AND BANDAGING PROTOCOL WAS NOT FOLLOWED. THE RECIPIENT'S MAGNET REPORTEDLY ROTATED. ON (B)(6) 2024, THE RECIPIENT'S MAGNET WAS REVISED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21093429 ↗
• MalfunctionDec 2, 2024Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure; Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN WITH DEVICE USE AFTER GOING DOWN A SLIDE. THE RECIPIENT IS PRESENTING WITH INTERMITTENCIES. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER THE ISSUE DID NOT RESOLVE. DEVICE TESTING REVEALED ABNORMAL RESULTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 20824485 ↗
• InjuryOct 18, 2024Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Communication Failure; Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING NO SOUND FOLLOWING A HEAD TRAUMA INCIDENT. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Head Injury

  MAUDE report 20482261 ↗
• InjuryOct 3, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING A DISPLACED MAGNET FOLLOWING AN MRI. THE RECIPIENT IS PRESENTING WITH PAIN. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Pain

  MAUDE report 20364232 ↗
• InjurySep 24, 2024Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AT THE IMPLANT SITE. THE RECIPIENT PRESENTED WITH DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE RECIPIENT HEALED.

  Patient problems: Unspecified Infection

  MAUDE report 20294353 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SKIN BREAKDOWN OVER MAGNET SITE. THE RECIPIENT WAS REPORTEDLY ADVISED TO CEASE DEVICE USE. THE RECIPIENT HAS EXPERIENCED SIGNIFICANT WEIGHT LOSS.

  Patient problems: Tissue Breakdown

  MAUDE report 20164358 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS EXPERIENCING TINNITUS. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. REVISION SURGERY IS SCHEDULED.

  Patient problems: Tinnitus

  MAUDE report 19715446 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMING ADJUSTMENTS WERE MADE, HOWEVER THE ISSUE DID NOT RESOLVE. THE RECIPIENT HAS GRANULATION IN THE EAR CANAL AND WAS PRESCRIBED AN OINTMENT (TYPE UNKNOWN). IT IS BELIEVED THE RECIPIENT MAY HAVE OSSIFICATION OF THE COCHLEA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19249547 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT'S DEVICE WAS EXPLANTED TO TREAT A CHOLESTEATOMA. THE RECIPIENT WILL BE REIMPLANTED AT A LATER DATE. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19226711 ↗
• MalfunctionApr 23, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED NON AUDITORY SENSATIONS. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER THE ISSUE DID NOT RESOLVE. SOME DEVICE TESTING COULD NOT BE COMPLETED DUE TO RECIPIENT DISCOMFORT. DEVICE TESTING COMPLETED REVEALED ABNORMAL RESULTS. REVISION SURGERY WILL BE SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19164794 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING RECURRENT INFECTIONS. A SURGERY TO RESOLVE THE INFECTION WAS REPORTEDLY PERFORMED. THE RECIPIENT IS PRESENTING WITH A LOSS OF SOUND. DEVICE TESTING WAS WITHIN NORMAL LIMITS. REVISION SURGERY WILL BE SCHEDULED.

  Patient problems: Unspecified Infection

  MAUDE report 18495906 ↗
• InjuryNov 10, 2023Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED CHOLESTEATOMA AND DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED. THE RECIPIENT HAS HEALED AFTER SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 18112854 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING AN INFECTION ON HIS HEAD BEHIND THE PINNA. THE RECIPIENT RECEIVED TREATMENT (TYPE UNKNOWN) AND WAS INSTRUCTED BY A NURSE TO USE AQUAPHOR.

  Patient problems: Unspecified Infection

  MAUDE report 17968273 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A CHOLESTEATOMA. THE RECIPIENT RECEIVED TREATMENT (TYPE UNKNOWN). ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 17961083 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960058. One submission often covers many models, so check the product and lot details in each record.

• Z-2283-2026 · Apr 30, 2026 · Open, Classified
  Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiReso
• Z-1950-2026 · Mar 23, 2026 · Open, Classified
  Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; C
• Z-1813-2025 · Mar 5, 2025 · Open, Classified
  HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
• Z-2032-2020 · Feb 17, 2020 · Terminated
  AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with prof
• Z-2033-2020 · Feb 17, 2020 · Terminated
  AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorine
• Z-1441-2020 · Apr 4, 2019 · Terminated
  SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave
• Z-1084-2019 · Feb 6, 2019 · Terminated
  Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
• Z-1085-2019 · Feb 6, 2019 · Terminated
  Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
• Z-1083-2019 · Feb 6, 2019 · Terminated
  Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
• Z-2039-2009 · Jun 10, 2009 · Terminated
  Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory sensation to patients
• Z-0958-2009 · Jul 24, 2008 · Terminated
  S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in
• Z-0956-2009 · Jul 24, 2008 · Terminated
  HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with spee
• Z-0959-2009 · Jul 24, 2008 · Terminated
  S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used i
• Z-0957-2009 · Jul 24, 2008 · Terminated
  Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear
• Z-0759-06 · Mar 8, 2006 · Terminated
  The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H.

…and 1 more.