HiRes Ultra 3D CI HiFocus SlimJ 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
- 1,049
- Deaths reported
- 0
- Injuries reported
- 381
- Recalls
- 0
We found 2 models of HiRes Ultra 3D CI HiFocus SlimJ Electrode by Advanced Bionics AG in the FDA's device registry (GUDID). Together they are named in 1,049 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2019 and Sep 30, 2026 — classified as 381 injuries, 668 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (620 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 SlimJ Electrode problems
Device problems
- Mechanical Problem620
- Adverse Event Without Identified Device or Use Problem307
- Impedance Problem248
- Migration122
- Output Problem61
- Therapeutic or Diagnostic Output Failure52
- Migration or Expulsion of Device49
- Appropriate Device Problem Term/Code Not Available48
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available725
- Failure of Implant194
- Insufficient Information194
- No Clinical Signs, Symptoms or Conditions60
- Unspecified Infection52
- Pain47
- Therapeutic Response, Decreased43
- Dizziness17
HiRes Ultra 3D CI HiFocus SlimJ 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™ SlimJ Electrode CI-1601-05Implant, Cochlear795 reports
- HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05Implant, Cochlear254 reports
Recent HiRes Ultra 3D CI HiFocus SlimJ Electrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
The company was informed that the recipient's device was explanted. The following was noted, left side auricular pinna carcinoma with a possible indication for adjuvant radiotherapy. The explanted device was received at Advanced Bionics on (b)(6) 2026, and is currently undergoing analysis.
Patient problems: Solid Tumor
MAUDE report 50941686 ↗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 ↗MalfunctionSep 4, 2026Expulsion; Migration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50600844 ↗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 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT'S DEVICE WAS EXPLANTED REPORTEDLY FOR AN INFECTION. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Unspecified Infection
MAUDE report 25036515 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT WAS EXPLANTED AND REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24933790 ↗InjuryApr 20, 2026Expulsion; Adverse Event Without Identified Device or Use Problem
THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS REPOSITIONED. PRIOR TO REPOSITIONING, THE SURGEON REPORTED A VISIBLE SKIN BREAKDOWN, AND THE DEVICE EXPOSED, HOWEVER, NO CLEAR INFECTION SIGNS WERE NOTED. DURING THE REPOSITIONING SURGERY, THE SURGEON CLEANED THE IMPLANT SITE AND SUTURED THE SKIN. THE RECIPIENT IS HEALING WELL.
Patient problems: Erosion; Wound Infection
MAUDE report 24933787 ↗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 24, 2026Migration
THE RECIPIENT IS REPORTEDLY EXPERIENCING DEVICE MIGRATION AND SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, AND IMPROVEMENT WAS NOTED. THE DEVICE WAS REPOSITIONED ON (B)(6) 2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24682619 ↗
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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