HiRes 90K™ CI HiFocus Helix™ Electrode CI-1400-02HRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 07630016816260), received between Aug 14, 2018 and Jan 15, 2026 — classified as 10 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (16 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Electrical Shorting

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SHORTED ELECTRODES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE IS NOT RESOLVED. IT IS NOTED THAT THERE WAS AN ELECTROSTATIC DISCHARGE EVENT (ESD). REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 24082638 ↗
• MalfunctionAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY AND IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, AND EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT REPORTEDLY CEASED USE OF THE DEVICE.

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

  MAUDE report 22867692 ↗
• MalfunctionJul 24, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. DEVICE TESTING REVEALED SHORT CIRCUITS AND ABNORMAL RESULTS. 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; Failure of Implant

  MAUDE report 22588031 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. DEVICE TESTING REVEALED SHORT CIRCUITS FOR A FEW ELECTRODES. ADVANCED BIONICS IS 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; Failure of Implant

  MAUDE report 22532288 ↗
• MalfunctionJul 15, 2025Mechanical Problem; Electrical Shorting; Mechanical Problem; Electrical Shorting

  THE RECIPIENT REPORTEDLY EXPERIENCED POOR PERFORMANCE. DEVICE TESTING REVEALED SHORT CIRCUITS FOR SEVERAL ELECTRODES. EQUIPMENT WAS CONFIRMED TO BE IN GOOD CONDITION. THE RECIPIENT'S DEVICE WAS EXPLANTED.

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

  MAUDE report 22514932 ↗
• MalfunctionJul 7, 2025High impedance; Mechanical Problem; High impedance; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. 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; Failure of Implant

  MAUDE report 22422421 ↗
• MalfunctionJan 30, 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 21273449 ↗
• MalfunctionJan 29, 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 EXPERIENCED SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS HAD BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. 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 21263560 ↗
• InjuryJan 7, 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 21093427 ↗
• InjuryJan 7, 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 21093426 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  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 21056400 ↗
• MalfunctionDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED OPEN ELECTRODES. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES. DEVICE TESTING REVEALED ABNORMAL RESULTS. 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 20886316 ↗
• MalfunctionDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. THE EXTERNAL DEVICE WAS NOTED AS WORKING. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

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

  MAUDE report 20872428 ↗
• InjuryNov 11, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN OPEN ELECTRODE. DEVICE TESTING CONFIRMED AN OPEN ELECTRODE. 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; Failure of Implant

  MAUDE report 20657279 ↗
• MalfunctionOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING OPEN ELECTRODES AND DECREASED PERFORMANCE. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED AND PROGRAMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE HAS NOT RESOLVED. REVISION SURGERY HAS BEEN SCHEDULED.

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

  MAUDE report 20513942 ↗
• MalfunctionSep 12, 2024Mechanical Problem; Mechanical Problem

  A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT IS USING THE DEVICE. REVISION SURGERY IS UNDER CONSIDERATION.

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

  MAUDE report 20208707 ↗
• MalfunctionSep 12, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 20208069 ↗
• MalfunctionAug 13, 2024Intermittent Continuity; Mechanical Problem; Electrical Shorting; Intermittent Continuity; Mechanical Problem; Electrical Shorting

  THE RECIPIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES AND DECREASED PERFORMANCE. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

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

  MAUDE report 19973564 ↗
• MalfunctionMar 18, 2024Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure; Electrical /Electronic Property Problem; Electrostatic Discharge; Intermittent Communication Failure

  THE RECIPIENT REPORTEDLY EXPERIENCED LOSS OF LOCK AND SOUND INTERMITTENCIES. DEVICE TESTING COULD NOT BE PERFORMED DUE TO NO LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER THE ISSUE DID NOT RESOLVE. 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; Failure of Implant

  MAUDE report 18927269 ↗
• MalfunctionSep 18, 2023Electrical /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 EXPERIENCED OVERLY LOUD SOUND ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE. 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 17764940 ↗
• MalfunctionJun 5, 2023Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. DEVICE TESTING REVEALED OPEN ELECTRODES. 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 17058886 ↗
• MalfunctionMar 29, 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. 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

  MAUDE report 16636217 ↗
• MalfunctionMar 3, 2023Application Program Problem; Intermittent Communication Failure; Intermittent Communication Failure

  THE RECIPIENT REPORTEDLY EXPERIENCED INTERMITTENT LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED. DURING PROGRAMMING THE RECIPIENT EXPERIENCED LOSS OF LOCK.

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

  MAUDE report 16482459 ↗
• MalfunctionFeb 17, 2023Electrical /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 EXPERIENCED DECREASED PERFORMANCE AND OPEN ELECTRODES. 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 16397711 ↗
• MalfunctionFeb 6, 2023Mechanical Problem; Impedance Problem; Mechanical Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2022. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE ON (B)(6) 2022.

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

  MAUDE report 16309500 ↗

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-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-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-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-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

…and 2 more.