HiRes 90K™ CI HiFocus™ 1j Electrode CI-1400-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07630016816253), received between Jun 29, 2018 and Aug 25, 2025 — classified as 32 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Intermittent Communication Failure” (8 reports).

17 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE RECIPIENT REPORTEDLY ELECTED DEVICE EXPLANT DUE TO A TECHNOLOGY UPGRADE. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE EXPLANTED DEVICE WILL NOT RETURN TO ADVANCED BIONICS FOR ANALYSIS.

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

  MAUDE report 22891156 ↗
• MalfunctionMay 30, 2025Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING NON-AUDITORY SENSATIONS WITH DEVICE USE. THE RECIPIENT IS REPORTEDLY UNABLE TO USE THE DEVICE. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED AND PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Undesired Nerve Stimulation

  MAUDE report 22115300 ↗
• MalfunctionApr 24, 2025Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCES PAIN WITH DEVICE USE. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT IMPROVE. DEVICE TESTING COULD NOT BE PERFORMED DUE TO PAIN. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21900468 ↗
• MalfunctionApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY ELECTED REVISION SURGERY FOR A TECHNOLOGY UPGRADE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

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

  MAUDE report 21743464 ↗
• MalfunctionMar 31, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING NO LOCK AND NO SOUND. 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; Failure of Implant

  MAUDE report 21735464 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. 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 21652196 ↗
• MalfunctionAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING OPEN ELECTRODES. DEVICE TESTING YIELDED ABNORMAL RESULTS. REVISION SURGERY IS UNDER CONSIDERATION.

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

  MAUDE report 19908015 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED CHRONIC MIDDLE EAR INFECTIONS. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Unspecified Infection

  MAUDE report 19511004 ↗
• MalfunctionMar 8, 2024Loose or Intermittent Connection; Mechanical Problem; Intermittent Communication Failure; Loose or Intermittent Connection; Mechanical Problem; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING INTERMITTENT LOCK, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE ISSUE DID NOT RESOLVE. A CT SCAN REVEALED NO ABNORMALITIES WITH THE IMPLANT PROPER LEAD PLACEMENT.

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

  MAUDE report 18871535 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING A SKIN FLAP INFECTION. THE RECIPIENT IS PRESENTING WITH NECROSIS WHICH REQUIRED SURGICAL INTERVENTION. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 17877472 ↗
• InjurySep 27, 2023Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure; Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE WAS NOT RESOLVED. INTEGRITY TESTING COULD NOT BE COMPLETED DUE TO NO LOCK. REVISION SURGERY IS UNDER CONSIDERATION.

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

  MAUDE report 17827689 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SWELLING AND PAIN AT IMPLANT SITE DUE TO A FLIPPED MAGNET FOLLOWING AN MRI. BANDAGING PROTOCOL WAS NOT FOLLOWED. THE RECIPIENT IS REPORTEDLY USING ANTI-INFLAMMATORY MEDICATION (TYPE UNKNOWN). THE RECIPIENT IS REPORTEDLY USING THE DEVICE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17719886 ↗
• MalfunctionJul 14, 2023Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure; Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN. THE RECIPIENT REFUSES TO WEAR DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUES DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Pain

  MAUDE report 17328330 ↗
• MalfunctionApr 3, 2023Adverse Event Without Identified Device or Use Problem; Intermittent Communication Failure; Adverse Event Without Identified Device or Use Problem; Intermittent Communication Failure

  THE RECIPIENT IS, REPORTEDLY, EXPERIENCING LOSS OF SOUND AND OPEN ELECTRODES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. DEVICE TESTING REVEALED ABNORMAL RESULTS.

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

  MAUDE report 16663612 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED OVERLY LOUD SOUND WITH DEVICE USE. DEVICE TESTING WAS WITHIN NORMAL LIMITS, PROGRAMMING ADJUSTMENTS WERE MADE AND IMPROVEMENT WAS NOTED. THE RECIPIENT'S DEVICE WAS EXPLANTED.

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

  MAUDE report 16132770 ↗
• MalfunctionDec 7, 2022Mechanical Problem; Output Problem; Intermittent Communication Failure; Mechanical Problem; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. DEVICE TESTING COULD NOT BE COMPLETED DUE TO LOSS OF LOCK. REVISION SURGERY WILL BE SCHEDULED.

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

  MAUDE report 15936241 ↗
• MalfunctionDec 7, 2022Mechanical Problem; Output Problem; Intermittent Communication Failure; Mechanical Problem; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. DEVICE TESTING COULD NOT BE COMPLETED DUE TO LOSS OF LOCK. REVISION SURGERY WILL BE SCHEDULED.

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

  MAUDE report 15936204 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING RECURRENT CHRONIC OTITIS MEDIA FOR THE PAST FIVE MONTHS. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED. THE RECIPIENT'S INFECTION HAS IMPROVED.

  Patient problems: Infectious Otitis Media; Skin Infection

  MAUDE report 15536012 ↗
• MalfunctionAug 26, 2022Expulsion; Expulsion; Material Protrusion/Extrusion; Output Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED EXTRUSION AND INFLAMMATION THAT WAS TREATED (TYPE UNKNOWN). THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATES POTENTIAL IMPEDANCE ISSUES. THE RECIPIENT WILL CONTINUE TO MONITORED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15307532 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED RECURRENT MIDDLE EAR INFECTION AND DRAINAGE SINCE 2020. THE RECIPIENT WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN) AND TREATMENT. A CT SCAN REVELED EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL NOT BE REIMPLANTED.

  Patient problems: Fluid Discharge; Skin Infection; Unspecified Infection

  MAUDE report 15283666 ↗
• InjuryMay 27, 2022Expulsion; Material Protrusion/Extrusion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED SWELLING, PAIN AND DEVICE EXTRUSION STARTING IN (B)(6) 2021. THE RECIPIENT'S DEVICE WAS EXPLANTED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14522159 ↗
• MalfunctionFeb 2, 2022Electrical /Electronic Property Problem; Electrostatic Discharge; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Electrostatic Discharge; Appropriate Device Problem Term/Code Not Available

  THE RECIPIENT IS REPORTEDLY EXPERIENCING NO LOCK. DEVICE TESTING COULD NOT BE COMPLETED DUE TO NO LOCK. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Insufficient Information; Pain; Undesired Nerve Stimulation

  MAUDE report 13428690 ↗
• InjuryFeb 1, 2022Intermittent Communication Failure; Connection Problem; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER THE ISSUES DID NOT RESOLVE. REVISION SURGERY WILL BE SCHEDULED

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

  MAUDE report 13416989 ↗
• InjuryJun 18, 2021Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED TRAUMA AT THE IMPLANT SITE. ON (B)(6) 2019, THE RECIPIENT PRESENTED WITH EDEMA AND WAS TREATED WITH AMOXICILLIN AND SULBACTAM. THE EDEMA RESOLVED. ON (B)(6) 2020, THE EDEMA RECURRED. THE RECIPIENT WAS TREATED WITH CETIBUTEN, HOWEVER, THE ISSUE DID NOT RESOLVE. ON (B)(6) 2020, THE RECIPIENT PRESENTED WITH AN EXTRUDED DEVICE. THE RECIPIENT UNDERWENT SKIN FLAP REVISION SURGERY. ON (B)(6) 2021, THE RECIPIENT PRESENTED WITH AN EXTRUDED DEVICE AGAIN, AND THE RECIPIENT UNDERWENT EXPLANT SURGERY. THE RECIPIENT WAS NOT REIMPLANTED. THE RECIPIENT RECOVERED WELL.

  Patient problems: Failure of Implant; Skin Infection; Swelling/ Edema

  MAUDE report 12022519 ↗
• MalfunctionApr 2, 2021Electrical /Electronic Property Problem; Electrostatic Discharge; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Electrostatic Discharge

  THE RECIPIENT REPORTEDLY EXPERIENCED AN ELECTROSTATIC DISCHARGE (ESD) EVENT. THE RECIPIENT PRESENTS WITH PAIN AND NON-AUDITORY SENSATIONS. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. DEVICE TESTING REVEALED ABNORMAL RESULTS. REVISION SURGERY WILL BE SCHEDULED.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 11611311 ↗

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-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-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-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-1259-2020 · Mar 18, 2019 · Terminated
  HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
• 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-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-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-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-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

…and 2 more.