HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05 (UDI 07630016862267)Recalls & reported problems
Advanced Bionics AG · Class 3 · Implant
All models of HiRes Ultra 3D CI HiFocus SlimJ Electrode (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Advanced Bionics HiRes Ultra 3D cochlear implant electrode has 791 FDA reports: 644 malfunctions, 147 injuries and no deaths. Recent reports mostly describe reduced performance linked to electrical impedance problems, with some patients needing revision surgery, and one describes an electrode moving into the ear canal. There are no recalls naming this device. Reports fell from 80 in the previous 12 months to 28 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 795
- Deaths reported
- 0
- Injuries reported
- 147
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 795 adverse event reports that list this exact device (DI 07630016862267), received between Feb 12, 2019 and Sep 25, 2026 — classified as 147 injuries, 648 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (618 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem618
- Impedance Problem247
- Adverse Event Without Identified Device or Use Problem159
- Output Problem51
- Therapeutic or Diagnostic Output Failure49
- Appropriate Device Problem Term/Code Not Available39
- Migration23
- Insufficient Device Problem Information20
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available579
- Failure of Implant177
- Insufficient Information166
- No Clinical Signs, Symptoms or Conditions54
- Therapeutic Response, Decreased43
- No Known Impact Or Consequence To Patient17
- Pain17
- Unspecified Infection17
Recent adverse event reports
The 25 most recent of 795 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50905541 ↗MalfunctionSep 25, 2026Mechanical Problem
The recipient reportedly experienced decreased performance. A review of the recipient¿s test data indicated impedance issues. The recipient's device was explanted. The recipient was reimplanted with another Advanced Bionics cochlear device.
Patient problems: Insufficient Information
MAUDE report 50898212 ↗MalfunctionSep 15, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50776690 ↗MalfunctionSep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50741594 ↗MalfunctionAug 4, 2026Mechanical Problem
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50131748 ↗MalfunctionMay 26, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25278453 ↗MalfunctionMay 21, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER; THE ISSUE DID NOT RESOLVE. THE RECIPIENT IS SCHEDULED FOR REVISION SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25249833 ↗MalfunctionApr 3, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE AND IMPROVEMENT NOTED. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Hyporesponsive to stimuli; No Clinical Signs, Symptoms or Conditions
MAUDE report 24780842 ↗MalfunctionApr 3, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE AND IMPROVEMENTS WERE NOTED. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24775011 ↗InjuryMar 20, 2026Migration
THE COMPANY WAS INFORMED THAT THE RECIPIENT IS REPORTEDLY EXPERIENCING ELECTRODE MIGRATION INTO THE EAR CANAL, ALONG WITH BALANCE ISSUES. THE RECIPIENT REPORTS DIZZINESS WHEN THE DEVICE IS POWERED ON. CT SCAN HAS CONFIRMED ELECTRODES OUTSIDE THE COCHLEA. THE PHYSICIAN HAS REPORTED THAT THE RECIPIENT'S EAR CANAL WALL HAS ERODED. THE RECIPIENT IS NOT CURRENTLY USING THE DEVICE AND HAS REQUESTED THE DEVICE TO BE REMOVED. REVISION SURGERY WILL BE SCHEDULED.
Patient problems: Balance Problems; Dizziness
MAUDE report 24651204 ↗MalfunctionMar 12, 2026Mechanical Problem; Lack of Effect
THE RECIPIENT REPORTEDLY EXPERIENCING SHORT CIRCUITS. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT IS SCHEDULED FOR REVISION SURGERY.
Patient problems: Hyporesponsive to stimuli
MAUDE report 24586045 ↗MalfunctionMar 12, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE AND SOUND QUALITY ISSUES. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT IS REPORTEDLY A NON-USER. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24586044 ↗MalfunctionFeb 3, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE AND IMPROVEMENT WAS NOTED. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24254401 ↗MalfunctionFeb 3, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, AND SLIGHT IMPROVEMENT WAS NOTED. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 24254225 ↗MalfunctionJan 23, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 24167650 ↗MalfunctionJan 22, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED A DECREASE IN PERFORMANCE AND SOUND QUALITY ISSUES. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. 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; Failure of Implant
MAUDE report 24156852 ↗MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. 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 23905584 ↗MalfunctionDec 23, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23882034 ↗MalfunctionDec 22, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 23872854 ↗MalfunctionDec 17, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE 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 23834896 ↗MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. 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 23820359 ↗MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23818778 ↗MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23818776 ↗MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23818770 ↗MalfunctionDec 15, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. 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 23805142 ↗
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, ClassifiedBrand 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, ClassifiedBrand 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, ClassifiedHiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
- Z-2032-2020 · Feb 17, 2020 · TerminatedAB 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 · TerminatedAB 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 · TerminatedSoundWave 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 · TerminatedHiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
- Z-1085-2019 · Feb 6, 2019 · TerminatedNada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
- Z-1084-2019 · Feb 6, 2019 · TerminatedNada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
- Z-1083-2019 · Feb 6, 2019 · TerminatedNada 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 · TerminatedAdvanced 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 · TerminatedHR90K 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 · TerminatedS-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 · TerminatedPlatinum 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 · TerminatedS-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.
Other Implant, Cochlear devices
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Advanced Bionics AG · Implant, Cochlear2,918 reports
- Cochlear® Nucleus® CI512 cochlear ImplantCochlear Limited · IMPLANT, COCHLEAR2,771 reports
- Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCochlear Limited · Implant, cochlear2,115 reports
- Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCochlear Limited · Implant, cochlear2,057 reports
- Nucleus Z60353Cochlear Limited · IMPLANT, COCHLEAR2 deaths1,815 reports
- Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCochlear Limited · IMPLANT, COCHLEAR1,475 reports
- Cochlear® Nucleus® CI612 cochlear ImplantCochlear Limited · Implant, cochlear1,150 reports
- Nucleus Z190574Cochlear Limited · IMPLANT, COCHLEAR981 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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