HiRes Ultra 3D CI HiFocus MS ElectrodeRecalls & reported problems across all models
Advanced Bionics AG · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,126
- Deaths reported
- 1
- Injuries reported
- 291
- Recalls
- 0
We found 2 models of HiRes Ultra 3D CI HiFocus MS Electrode by Advanced Bionics AG in the FDA's device registry (GUDID). Together they are named in 1,126 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2018 and Sep 21, 2026 — classified as 1 death, 291 injuries, 834 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (773 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HiRes Ultra 3D CI HiFocus MS Electrode problems
Device problems
- Mechanical Problem773
- Impedance Problem355
- Adverse Event Without Identified Device or Use Problem287
- Output Problem75
- Therapeutic or Diagnostic Output Failure64
- Appropriate Device Problem Term/Code Not Available51
- Insufficient Device Problem Information38
- Expulsion27
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available722
- Insufficient Information250
- Failure of Implant232
- Unspecified Infection52
- Pain51
- Therapeutic Response, Decreased51
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient21
HiRes Ultra 3D CI HiFocus MS Electrode models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04Implant, Cochlear1 death931 reports
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04Implant, Cochlear195 reports
Recent HiRes Ultra 3D CI HiFocus MS Electrode adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50765608 ↗MalfunctionSep 14, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50765605 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
The recipient is reportedly electing explant surgery due to being a non-user and wanting to be part of the deaf culture. Revision surgery is scheduled.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50762161 ↗InjurySep 8, 2026No Device Output; Intermittent Communication Failure
Patient problems: Head Injury
MAUDE report 50679230 ↗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 ↗
Other Advanced Bionics AG products
All Advanced Bionics AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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