HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04 (UDI 07630016877995)Recalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 07630016877995), received between Mar 5, 2020 and Sep 14, 2026 — classified as 183 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Expulsion” (24 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 195 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50765608 ↗
• 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 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SORENESS UNDER THE MAGNET SITE. THE MAGNET STRENGTH WAS DECREASED AND THE RECIPIENT WAS PRESCRIBED STEROID OINTMENT TO APPLY TWICE DAILY TO THE MAGNET SITE. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 24866822 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT DEVELOPED A CHOLESTEATOMA IN THE PARS FLACCIDA THAT WAS UNRELATED TO THE DEVICE. THE RECIPIENT REPORTEDLY HAD THE CHOLESTEATOMA REMOVED AT THE TIME OF EXPLANT. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

  Patient problems: Cholesteatoma; Unspecified Infection

  MAUDE report 24840750 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE RECIPIENT IS REPORTEDLY A NON-USER OF THE DEVICE AND IS ELECTING EXPLANT SURGERY. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

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

  MAUDE report 24586601 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED SKIN INFLAMMATION AT THE IMPLANT SITE DUE TO A POSSIBLE REACTION. THE RECIPIENT PRESENTED WITH PAIN. ADVANCED BIONICS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation; Pain; Skin Inflammation/ Irritation

  MAUDE report 24324172 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED SKIN BREAKDOWN AND AN INFECTION AT THE MAGNET SITE. THE RECIPIENT WAS ADVISED TO CEASE DEVICE USE AND PRESCRIBED MEDICATION (TYPE UNKNOWN). THE MAGNET STRENGTH WAS DECREASED, AND THE RECIPIENT WAS HEALING WELL. THE RECIPIENT WAS ADVISED TO DISCONTINUE USE FOR AN ADDITIONAL TWO WEEKS AND RESUME DEVICE USE ONCE MEDICALLY CLEARED.

  Patient problems: Skin Erosion; Skin Infection

  MAUDE report 24258119 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REPORTEDLY IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. 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 24157032 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN WITH AND WITHOUT DEVICE USE. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. PROGRAMMING ADJUSTMENTS HAD BEEN MADE. THE RECIPIENT WAS REPORTEDLY PRESCRIBED STEROIDS (TYPE UNKNOWN).

  Patient problems: Pain

  MAUDE report 23819177 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING RETENTION ISSUES. THE RECIPIENT REPORTEDLY UNDERWENT A SKIN FLAP THINNING PROCEDURE; HOWEVER, THE ISSUE DID NOT RESOLVE.

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

  MAUDE report 23819171 ↗
• MalfunctionDec 11, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING NO SOUND. THE RECIPIENT REPORTEDLY FELL AND HIT THEIR HEAD AT THE IMPLANT SITE. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS SCHEDULED.

  Patient problems: Failure of Implant; Fall; Head Injury

  MAUDE report 23785877 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED STROKE-LIKE SYMPTOMS. THE RECIPIENT PRESENTED WITH LIGHTHEADEDNESS AND DIZZINESS. THE RECIPIENT WAS HOSPITALIZED. IT IS UNKNOWN IF THE ISSUES ARE DEVICE RELATED. THE RECIPIENT UNDERWENT AN MRI THAT WAS INCONCLUSIVE.

  Patient problems: Dizziness

  MAUDE report 23784342 ↗
• MalfunctionDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT REFUSES TO WEAR THE DEVICE.

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

  MAUDE report 23721288 ↗
• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING OPEN ELECTRODES. EXTERNAL EQUIPMENT WAS EXCHANGED AND 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 23658106 ↗
• InjuryOct 24, 2025Migration or Expulsion of Device; Expulsion; Migration or Expulsion of Device; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED ELECTRODE EXTRUSION. REVISION SURGERY IS UNDER CONSIDERATION.

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

  MAUDE report 23384118 ↗
• InjurySep 5, 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 WILL REPORTEDLY RECEIVE IT STEROID INJECTIONS.

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

  MAUDE report 22986736 ↗
• InjurySep 3, 2025Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE EXPULSION DUE TO SKIN FLAP BREAKDOWN. NO INFECTION OR MEDICAL INTERVENTION WERE NOTED. THE RECIPIENT¿S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT RE-IMPLANTED.

  Patient problems: Skin Erosion

  MAUDE report 22954148 ↗
• InjuryAug 4, 2025Migration; Migration

  THE RECIPIENT IS EXPERIENCING ELECTRODE MIGRATION. THE RECIPIENT IS PRESENTING WITH PAIN AND DISCOMFORT BEHIND THE PINNA. THE RECIPIENT IS NOT WEARING THE DEVICE DUE TO DISCOMFORT. A REPOSITIONING SURGERY IS SCHEDULED.

  Patient problems: Discomfort; Pain

  MAUDE report 22700578 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED LACK OF BENEFIT FROM THE DEVICE. THE RECIPIENT'S DEVICE WAS EXPLANTED.

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

  MAUDE report 22580527 ↗
• InjuryJul 14, 2025Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING AN INFECTION. THE RECIPIENT WAS INSTRUCTED TO CEASE DEVICE USE. IT IS NOTED THAT THE INFECTION IS DEEP INSIDE THE EAR AND NOT RELATED TO HIS MAGNET OR VISIBLE ON HIS SKIN. THE INFECTION IS NOT BELIEVED TO BE DEVICE RELATED. SURGERY IS UNDER CONSIDERATION.

  Patient problems: Ear infection; Skin Erosion; Unspecified Infection

  MAUDE report 22501082 ↗
• MalfunctionJun 27, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE 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; Failure of Implant

  MAUDE report 22350747 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING HEADACHES AND PAIN AT THE IMPLANT SITE WITH AND WITHOUT DEVICE USE. THE RECIPIENT WAS REPORTEDLY A NON-USER OF THE DEVICE. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. EXPLANT SURGERY HAS BEEN SCHEDULED.

  Patient problems: Headache; Pain

  MAUDE report 22345720 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE RECIPIENT IS REPORTEDLY EXPERIENCING HEADACHES, PAIN, AND TINNITUS WITH AND WITHOUT DEVICE USE. THE EXTERNAL MAGNET WAS EXCHANGED. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT WAS REPORTEDLY PRESCRIBED PROPRANOLOL, LEXAPRO, AND NORTRIPTYLINE.

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

  MAUDE report 22338041 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THE RECIPIENT IS REPORTEDLY A NON-USER. DEVICE TESTING AND AUDITORY BRAINSTEM RESPONSE (ABR) WERE REPORTEDLY CONDUCTED UNDER ANESTHESIA. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS.

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

  MAUDE report 22235996 ↗

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-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-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-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-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-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-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-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-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
• 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-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

…and 2 more.