HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05 (UDI 07630016857201)Recalls & reported problems
Advanced Bionics AG · Class 3 · Implant
All models of HiRes Ultra CI HiFocus SlimJ Electrode (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Advanced Bionics HiRes Ultra SlimJ cochlear implant electrode is placed inside the inner ear to help restore hearing. Its 334 reports mostly describe electrical resistance problems, poor sound quality and implants that had to be removed or replaced in revision surgery. The reports mention 55 injuries and no deaths. No recalls name this device. Reports fell from 38 in the prior 12 months to 12 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
- 335
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 07630016857201), received between Jun 28, 2018 and Sep 2, 2026 — classified as 55 injuries, 280 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (250 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 Problem250
- Impedance Problem103
- Adverse Event Without Identified Device or Use Problem49
- Therapeutic or Diagnostic Output Failure32
- Output Problem28
- Insufficient Device Problem Information17
- Appropriate Device Problem Term/Code Not Available16
- Migration or Expulsion of Device11
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available205
- Insufficient Information82
- Failure of Implant67
- Therapeutic Response, Decreased30
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient14
- Pain11
- No Information8
Recent adverse event reports
The 25 most recent of 335 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50571286 ↗MalfunctionMay 21, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, AND IMPROVEMENT WAS NOTED BUT NOT FULLY RESOLVED. REVISION SURGERY IS SCHEDULED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25249946 ↗MalfunctionMay 6, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING 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 COCHLEAR DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25104490 ↗MalfunctionApr 23, 2026Mechanical Problem
A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. PROGRAMMING CHANGES WERE MADE. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24972566 ↗MalfunctionApr 13, 2026Mechanical Problem
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 AND WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Failure of Implant
MAUDE report 24866817 ↗MalfunctionMar 25, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED 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'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE.
Patient problems: Failure of Implant
MAUDE report 24687773 ↗MalfunctionMar 13, 2026Mechanical Problem
A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24594375 ↗MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT RE-IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23823766 ↗MalfunctionDec 16, 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 HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23818772 ↗MalfunctionDec 15, 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 HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23802456 ↗MalfunctionDec 11, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23785690 ↗MalfunctionDec 1, 2025Mechanical Problem; Mechanical 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23680322 ↗MalfunctionNov 20, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED POTENTIAL IMPEDANCE ISSUES, DESPITE DEVICE TESTING RESULTS WITHIN NORMAL LIMITS. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23612273 ↗MalfunctionSep 19, 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 23095427 ↗MalfunctionSep 4, 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 22967293 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Prophylactic removal due to corrective action; Adverse Event Without Identified Device or Use Problem; Prophylactic removal due to corrective action
THE RECIPIENT IS REPORTEDLY ELECTING REVISION SURGERY, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22938439 ↗MalfunctionSep 2, 2025Mechanical Problem; Mechanical 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 COCHLEAR DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 22938122 ↗MalfunctionAug 29, 2025Mechanical Problem; Mechanical 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 22926616 ↗MalfunctionAug 14, 2025Mechanical Problem; Mechanical Problem
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; Failure of Implant
MAUDE report 22803683 ↗MalfunctionAug 13, 2025Mechanical Problem; Mechanical 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 COCHLEAR DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 22796158 ↗MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. REVISION SURGERY HAS BEEN SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 22719168 ↗MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem
A REVIEW OF THE RECIPIENT'S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT IS PRESENTING WITH SOUND QUALITY 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 22716456 ↗MalfunctionJul 11, 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 22480822 ↗MalfunctionJul 9, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF 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 22457695 ↗MalfunctionJun 20, 2025Mechanical Problem; Mechanical Problem
THE RECIPIENT WAS 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'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Failure of Implant
MAUDE report 22301603 ↗
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-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-1085-2019 · Feb 6, 2019 · TerminatedNada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
- 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-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
- 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
…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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