HiRes Ultra 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
- 2,919
- Deaths reported
- 0
- Injuries reported
- 266
- Recalls
- 0
We found 2 models of HiRes Ultra CI HiFocus MS Electrode by Advanced Bionics AG in the FDA's device registry (GUDID). Together they are named in 2,919 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Sep 30, 2026 — classified as 266 injuries, 2,653 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2,300 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 CI HiFocus MS Electrode problems
Device problems
- Mechanical Problem2,300
- Impedance Problem1,156
- Adverse Event Without Identified Device or Use Problem330
- Therapeutic or Diagnostic Output Failure324
- Output Problem226
- Insufficient Device Problem Information191
- Appropriate Device Problem Term/Code Not Available190
- Output below Specifications113
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1,759
- Insufficient Information710
- Failure of Implant692
- Therapeutic Response, Decreased317
- No Clinical Signs, Symptoms or Conditions172
- No Known Impact Or Consequence To Patient113
- No Information63
- Pain63
HiRes Ultra 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 CI HiFocus™ MS Electrode CI-1600-04Implant, Cochlear2,918 reports
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Implant, Cochlear1 report
Recent HiRes Ultra 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 30, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50953324 ↗MalfunctionSep 30, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50953323 ↗MalfunctionSep 25, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50905536 ↗MalfunctionSep 25, 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 50897747 ↗MalfunctionSep 24, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50890813 ↗MalfunctionSep 24, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50890260 ↗MalfunctionSep 22, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50860394 ↗MalfunctionSep 22, 2026Mechanical Problem
The recipient is reportedly experiencing decreased performance. A review of the recipient¿s test data indicated impedance issues. Device testing revealed results within normal limits. External equipment was exchanged, however, the issue did not resolve. Revision surgery is scheduled.
Patient problems: Insufficient Information
MAUDE report 50856688 ↗MalfunctionSep 22, 2026Mechanical Problem
The recipient reportedly experienced decreased performance. A review of the recipient¿s test data indicated impedance issues. 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 Advanced Bionics cochlear device.
Patient problems: Insufficient Information
MAUDE report 50854683 ↗MalfunctionSep 17, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50797065 ↗MalfunctionSep 8, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50671098 ↗MalfunctionSep 4, 2026Mechanical Problem; Unstable Impedance
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50600846 ↗MalfunctionSep 2, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50573464 ↗MalfunctionAug 31, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50528659 ↗InjuryAug 28, 2026Expulsion
Patient problems: Unspecified Infection
MAUDE report 50509667 ↗
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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