HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04 (UDI 07630016862250)Recalls & reported problems
Advanced Bionics AG · Class 3 · Implant
All models of HiRes Ultra 3D CI HiFocus MS Electrode (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Advanced Bionics HiRes Ultra 3D cochlear implant electrode is placed in the inner ear to help restore hearing. Reports mostly describe weaker performance and poorer sound quality, with impedance problems found in test data, and several recipients needed the device removed and replaced. There are 925 reports, 1 death and 108 injuries. No recalls name this device. Reports fell from 97 in the prior 12 months to 23 in the latest 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
- 931
- Deaths reported
- 1
- Injuries reported
- 108
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 931 adverse event reports that list this exact device (DI 07630016862250), received between Dec 20, 2018 and Sep 21, 2026 — classified as 1 death, 108 injuries, 822 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (767 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 Problem767
- Impedance Problem353
- Adverse Event Without Identified Device or Use Problem139
- Output Problem70
- Therapeutic or Diagnostic Output Failure60
- Appropriate Device Problem Term/Code Not Available47
- Insufficient Device Problem Information35
- Output below Specifications23
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available637
- Insufficient Information237
- Failure of Implant220
- Therapeutic Response, Decreased51
- No Clinical Signs, Symptoms or Conditions46
- No Known Impact Or Consequence To Patient21
- Unspecified Infection20
- Pain13
Recent adverse event reports
The 25 most recent of 931 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 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. Revision surgery is scheduled.
Patient problems: Insufficient Information
MAUDE report 50845837 ↗MalfunctionSep 15, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50779672 ↗MalfunctionSep 15, 2026Mechanical 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
MAUDE report 50778694 ↗MalfunctionSep 14, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50765605 ↗MalfunctionSep 8, 2026Mechanical Problem; Patient Device Interaction Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50674924 ↗MalfunctionSep 4, 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 has been scheduled.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50601143 ↗MalfunctionAug 31, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50531272 ↗MalfunctionJun 17, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE AND SOUND QUALITY ISSUES. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT WAS ADVISED TO POSSIBLY DISCONTINUE USE OF DEVICE TILL REVISION. REVISION SURGERY WILL BE SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25534260 ↗MalfunctionMay 15, 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. THE RECIPIENT WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25188404 ↗MalfunctionMay 14, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT WAS EXPLANTED AND REIMPLANTED WITH ANOTHER ADVANCED BIONCIS DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25167021 ↗MalfunctionMay 6, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED 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 DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25104449 ↗MalfunctionApr 23, 2026Mechanical Problem
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 24968261 ↗MalfunctionApr 22, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem
THE RECIPIENT REPORTEDLY EXPERIENCED A FALL AND HIT THEIR HEAD, AFTER WHICH THE SURGEON NOTED THAT THE POSTAURICULAR WOUND IS TENDER TO PALPATIONS AND HAD BEGUN TO DEHISCE AND HAD INTERMITTENT PURULENT DRAINAGE. SINCE JANUARY, THE RECIPIENT HAD BEEN TREATED WITH DURICEF. UPON FURTHER PHYSICAL EXAMINATION, WOUND DEHISCENCE WAS OBSERVED ALONG THE ANTERIOR PORTION OF THE COCHLEAR IMPLANT, WITH EXPOSED UNDERLYING HARDWARE. VISUAL INSPECTION REVEALED PURULENCE AND CRUSTING WITHIN THE WOUND. IMAGING CONFIRMED THE IMPLANT WAS UNREMARKABLE. DUE TO THE LACK OF HEALING WITH CONSERVATIVE WOUND CARE, THE SURGEON DECIDED TO PROCEED WITH EXPLANTATION. THE RECIPIENT WAS EXPLANTED. THE WOUND WAS COPIOUSLY IRRIGATED AND TREATED WITH A TRIPLE ANTIBIOTIC SOLUTION, THEN CLOSED IN MULTIPLE LAYERS. AT THE TIME OF SURGERY, THE RECIPIENT¿S ANTIBIOTIC THERAPY WAS CHANGED FROM DURICEF TO AUGMENTIN. THE RECIPIENT IS PLANNED FOR RE-IMPLANTATION AT A LATER DATE ONCE THE INFECTION HAS RESOLVED.
Patient problems: Erosion; Fall; Head Injury; Medical device site infection; Purulent Discharge; Wound Infection
MAUDE report 24960463 ↗MalfunctionApr 20, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENTS TEST DATA INDICATE 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 24928019 ↗MalfunctionApr 13, 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 24866821 ↗MalfunctionApr 3, 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 COCHLEAR DEVICE.
Patient problems: Failure of Implant
MAUDE report 24783676 ↗MalfunctionMar 31, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES,. PROGRAMMING ADJUSTMENTS WERE MADE, AND IMPROVEMENT NOTED. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24747348 ↗MalfunctionMar 26, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24708444 ↗MalfunctionFeb 17, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24369365 ↗MalfunctionFeb 16, 2026Mechanical 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 24348294 ↗MalfunctionJan 28, 2026Mechanical Problem
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 24206405 ↗MalfunctionJan 26, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. THE RECIPIENT'S DEVICE WAS REPORTEDLY 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 24185593 ↗MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23820383 ↗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 23818768 ↗MalfunctionDec 11, 2025Mechanical Problem; Mechanical 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 IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23785878 ↗
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-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-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-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-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-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
- 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-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
…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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