HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05 (UDI 07630016878008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 07630016878008), received between Jul 29, 2020 and Sep 30, 2026 — classified as 234 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Migration” (99 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 254 reports, 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 4, 2026Expulsion; Migration

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50600844 ↗
• 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 ↗
• 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 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem; Migration

  THE RECIPIENT IS EXPERIENCING ELECTRODE MIGRATION. A CT SCAN CONFIRMED ELECTRODE MIGRATION. 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

  MAUDE report 24547798 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED, AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. PER THE OPERATION NOTES, A FULL INSERTION WAS ACHIEVED AT INITIAL IMPLANTATION. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24471967 ↗
• InjuryFeb 24, 2026Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED REDNESS AND SOME IRRITATION AT MAGNET SITE, AFTER LAYING ON HIS MAGNET SITE WITH THE PROCESSOR FOR EXTENDED PERIODS OF TIME. THE RECIPIENT WAS RECOMMENDED TO REDUCE DEVICE USE UNLESS ABSOLUTELY NECESSARY AND MAGNET STRENGTH WAS REDUCED. A PIECE OF GAUZE WAS ALSO USED INSTEAD OF MOLESKIN. HOWEVER, THE RECIPIENT CONTINUED TO USE THE DEVICE. THE RECIPIENT WAS AGAIN ADVISED TO CEASE DEVICE USE UNLESS NECESSARY. THE RECIPIENT WAS EVALUATED BY THE SURGEON ON (B)(6) 2026, WHO NOTED THE RECIPIENT IS REPORTEDLY EXPERIENCING SKIN FLAP BREAKDOWN WITH A VISIBLE ICS. THE RECIPIENT WAS ADVISED TO CEASE USE, AND A TOPICAL CREAM (TYPE: UNKNOWN) WAS PRESCRIBED FOR THE WOUND.

  Patient problems: Erosion; Skin Inflammation/ Irritation

  MAUDE report 24437085 ↗
• InjuryJan 26, 2026Difficult to Insert; Patient Device Interaction Problem; Lack of Effect

  THE RECIPIENT EXPERIENCED PROLONGED SURGERY AND PARTIAL INSERTION DUE TO BUILD UP OF SCAR TISSUE. THE RECIPIENT IS REPORTEDLY PRESENTING WITH POOR LOUDNESS GROWTH. PROGRAMMING ADJUSTMENTS HAD BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. A CT SCAN REVEALED NO ANOMALIES. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis

  MAUDE report 24185591 ↗
• InjuryJan 23, 2026Migration

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. A CT CONFIRMED THE RECIPIENT IS REPORTEDLY EXPERIENCING DEVICE MIGRATION. REVISION SURGERY WILL BE SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24167636 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 23900923 ↗
• InjuryNov 20, 2025Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE EXTRUSION. THE DEVICE HAD EXTRUDED THROUGH THE SKIN. IT IS NOTED THAT DURING A BIOPSY, THE IMPLANT AREA WAS DISTURBED WHICH IS BELIEVED TO HAVE CAUSED VISIBLE DAMAGE TO THE DEVICE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23612267 ↗
• InjuryOct 31, 2025Migration; Migration

  THE RECIPIENT'S DEVICE WAS REPORTEDLY EXPLANTED DUE TO PAIN AND DEVICE MIGRATION. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT.

  Patient problems: Pain

  MAUDE report 23442732 ↗
• MalfunctionOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY HAD PARTIAL INSERTION, PER SURGEON CHOICE, FOR RESIDUAL HEARING PRESERVATION. THE RECIPIENT EXPERIENCED SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENTS ARRAY WAS REINSERTED ON (B)(6) 2025.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23330241 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. THE RECIPIENT REPORTEDLY EXPERIENCED FACIAL NERVE STIMULATION AND PAIN. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 23296327 ↗
• MalfunctionOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES AND INCREASED IMPEDANCES. THE RECIPIENT IS PRESENTING WITH DIZZINESS. THE RECIPIENT WAS REPORTEDLY PRESCRIBED STEROIDS; HOWEVER, THE ISSUE DID NOT RESOLVE. PROGRAMMING ADJUSTMENTS WERE MADE.

  Patient problems: Dizziness

  MAUDE report 23295777 ↗
• InjuryOct 15, 2025Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE MIGRATION. A REPOSITIONING SURGERY OCCURRED ON (B)(6) 2024 WITHOUT COMPLICATIONS, HOWEVER, SOME TIME LATER, THE RECIPIENT REPORTEDLY EXPERIENCED AN ALLERGIC REACTION IN THE IMPLANT AREA. AN ALLERGY TEST REPORTEDLY CAME BACK NEGATIVE. THE RECIPIENT CONTINUED TO EXPERIENCE ALLERGIES AND DEVICE EXTRUSION. ON (B)(6) 2025, THE RECIPIENT'S DEVICE WAS EXPLANTED. A SPECIMEN WAS TAKEN FOR CULTURE. THE RECIPIENT WAS NOT REIMPLANTED AT THIS TIME.

  Patient problems: Foreign Body Reaction

  MAUDE report 23286362 ↗
• MalfunctionSep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING AN INCREASE IN IMPEDANCES AND DECREASED PERFORMANCE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23080074 ↗
• InjuryAug 18, 2025Migration; Migration

  THE COMPANY WAS INFORMED THAT THE RECIPIENT UNDERWENT ELECTRODE REPOSITIONING SURGERY ON (B)(6) 2025 AFTER IMAGING CONFIRMED ELECTRODE MIGRATION. TEST DATA INDICATED NORMAL LIMITS AFTER SURGERY. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22834499 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. DEVICE TESTING IS WITHIN NORMAL LIMITS. THE RECIPIENT REPORTEDLY HAS AN AIR POCKET. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22832855 ↗
• InjuryAug 13, 2025Expulsion; Adverse Event Without Identified Device or Use Problem; Migration; Expulsion; Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED SOUND QUALITY 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22797713 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE, AND IMPROVEMENT WAS NOTED. CT SCAN INDICATED THE ELECTRODE ARRAY LIES WITHIN THE MIDDLE AND APICAL TURNS OF THE COCHLEA. 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

  MAUDE report 22794730 ↗
• InjuryAug 8, 2025Migration; Migration

  THE RECIPIENT IS REPORTEDLY EXPERIENCING ELECTRODE MIGRATION AND DECREASED PERFORMANCE. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENT HAVE BEEN MADE, AND THE RECIPIENT CONTINUES TO WEAR THE DEVICE. A CT SCAN CONFIRMED MIGRATION. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22749932 ↗
• InjuryJul 23, 2025Migration; Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED ELECTRODE MIGRATION, CONFIRMED BY A CT. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22580578 ↗

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, Classified
  Brand 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, Classified
  Brand 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, Classified
  HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
• Z-2032-2020 · Feb 17, 2020 · Terminated
  AB 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 · Terminated
  AB 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 · Terminated
  SoundWave 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 · Terminated
  HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
• Z-1083-2019 · Feb 6, 2019 · Terminated
  Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
• Z-1084-2019 · Feb 6, 2019 · Terminated
  Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
• Z-1085-2019 · Feb 6, 2019 · Terminated
  Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
• Z-2039-2009 · Jun 10, 2009 · Terminated
  Advanced 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-0956-2009 · Jul 24, 2008 · Terminated
  HR90K 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-0957-2009 · Jul 24, 2008 · Terminated
  Platinum 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 · Terminated
  S-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-0959-2009 · Jul 24, 2008 · Terminated
  S-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.