HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04 (UDI 00840094455993)Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00840094455993), received between Apr 12, 2023 and Sep 11, 2026 — classified as 140 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Migration” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

16 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.

Recalls naming this device

1. Apr 30, 2026Class IIOpen, Classified

   Due to incorrect shelf-life expiration date.

   Z-2283-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Balance Problems

  MAUDE report 50741597 ↗
• MalfunctionSep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50551511 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  The recipient reportedly presented with a post aurical infection believed to be caused by the recipients glasses putting pressure across the incision and causing a wound. The silicone of the implant is visible. The recipient started treatment with bacitracin ointment and ciproflox. The recipient's device was explanted. The recipient will be reimplanted at a later date. The recipient is healing well.

  Patient problems: Unspecified Infection

  MAUDE report 50551503 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  The recipient is reportedly experiencing facial stimulation when wearing the processor and sound quality issues. Programming adjustments were made, with some improvement. The recipient reportedly received facial nerve botox.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50532303 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  The recipient is reportedly experiencing intermittent dizziness and imbalance since implant surgery. The bouts of dizziness reportedly only occur every month and a half. The recipient was prescribed prednisone and is going to see a VRT physical therapist. The recipient is progressing well with the device.

  Patient problems: Balance Problems; Dizziness

  MAUDE report 50484425 ↗
• InjuryAug 3, 2026Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  The recipient reportedly experienced partial electrode insertion. The recipient presented with intermittencies. Programming adjustments were made, however, the issue did not resolve. The recipient's device was explanted. The recipient was reimplanted with another cochlear device.

  Patient problems: Hyporesponsive to stimuli

  MAUDE report 50122676 ↗
• InjuryJun 22, 2026Malposition of Device

  THE RECIPIENT REPORTEDLY EXPERIENCED EXTENDED SURGERY TIME (30 MINUTES) DUE TO A COMPLICATION DURING INITIAL IMPLANT SURGERY. THE RECIPIENT HAD A PARTIAL INSERTED ELECTRODE DUE TO OSSIFICATION. A CT CONFIRMED THE ELECTRODE WAS NOT IN THE CORRECT POSITION. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Deformity/ Disfigurement; Extraskeletal ossification

  MAUDE report 25575762 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AT INCISION SITE. THE RECIPIENT HAS EXCORIATION DISORDER AND PICKED AT WOUND INFECTION. THE RECIPIENT DID NOT RESPOND TO ANTIBIOTICS OR DEBRIDEMENT. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL BE REIMPLANTED AT A LATER DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25279214 ↗
• InjuryMay 21, 2026Malposition of Device; Migration; Lack of Effect

  THE RECIPIENT IS REPORTEDLY EXPERIENCING ELECTRODE MIGRATION. THE RECIPIENT PRESENTED WITH NO AUDITORY RESPONSE TO STIMULATION. INTRAOPERATIVE X-RAY REPORTEDLY INDICATED FULL INSERTION. CT IMAGING CONFIRMED THE ELECTRODE ARRAY WAS LOCATED IN THE MIDDLE EAR SPACE. THE RECIPIENT IS NOT CURRENTLY USING THE DEVICE. REVISION SURGERY IS SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 25245348 ↗
• InjuryApr 15, 2026Patient Device Interaction Problem

  THE RECIPIENT REPORTED EXPERIENCING INTERMITTENCIES AND WAS ADVISED TO DISCONTINUE DEVICE USE. DEVICE INTEGRITY TESTING RESULTS WERE WITHIN NORMAL LIMITS. PROGRAMMING ADJUSTMENTS WERE MADE AND ALL EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE.

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

  MAUDE report 24888367 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DIZZINESS POST-SURGERY AND WAS PRESCRIBED STEROIDS (TYPE UNKNOWN) BUT HAS NOT TAKEN THE MEDICATION.

  Patient problems: Dizziness

  MAUDE report 24866818 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED PAIN AND SWELLING AT THE IMPLANT SITE. A SHOCKING SENSATION WAS ALSO NOTED WITH AND WITHOUT DEVICE USE. 2 ROUNDS OF ANTIBIOTICS WERE PRESCRIBED WITHOUT RESOLVE. THE RECIPIENT HAS AN UNSPECIFIED COCHLEAR MALFORMATION. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. IMPROVEMENT WAS NOTED WITH A 3RD ROUND OF ANTIBIOTICS, STEROIDS, AND PROGRAMMING ADJUSTMENTS. THE RECIPIENT PRESENTED WITH HEADACHES AND DRAINAGE.

  Patient problems: Fluid Discharge; Headache; Implant Pain; Pain; Swelling/ Edema; Wound Infection

  MAUDE report 24568531 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A POST AURICULAR ABSCESS IN (B)(6) 2025. THE RECIPIENT REPORTEDLY REQUIRED DRAINAGE OF THE POST AURICULAR ABSCESS. ANTIBIOTICS (TYPE UNKNOWN) WERE PRESCRIBED. THE INFECTION WAS NOT BELIEVE TO BE DEVICE RELATED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24547809 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED DUE TO CHRONIC INFECTION. THE RECIPIENT WAS NOT REIMPLANTED. THE RECIPIENT IS REPORTEDLY HEALING WELL.

  Patient problems: Ear infection

  MAUDE report 24547806 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING INITIAL IMPLANT SURGERY, THE RECIPIENT WAS REPORTEDLY HOSPITALIZED DUE TO DRAINAGE, DIZZINESS, BALANCE CONCERNS AND NYSTAGMUS. THE RECIPIENT WAS TREATED WITH ANTIBIOTICS, OMNICEF AND CIPRODEX DROPS. THE RECIPIENT'S SYMPTOMS ARE REPORTEDLY IMPROVING.

  Patient problems: Deformity/ Disfigurement; Dizziness; Fluid Discharge

  MAUDE report 24462932 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DIZZINESS FOLLOWING INITIAL IMPLANT SURGERY. MEDICATION WAS PRESCRIBED (TYPE: MECLIZINE). THE RECIPIENT WAS REFERRED TO PHYSICAL THERAPY AND ADVISED TO STOP TAKING MECLIZINE AS SOME OF THE SIDE EFFECTS INCLUDE VERTIGO, DIZZINESS, AND NAUSEA. THE RECIPIENT REPORTEDLY NOW USES A CANE BUT HAS STARTED PHYSICAL THERAPY AND DIZZINESS HAS IMPROVED.

  Patient problems: Dizziness; Vertigo

  MAUDE report 24423374 ↗
• InjuryFeb 18, 2026Migration or Expulsion of Device; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION DUE TO DEVICE EXTRUSION. THE RECIPIENT PRESENTED WITH MIGRATION AND DISCOMFORT. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE RECIPIENT IS RECOVERING FROM THE INFECTION.

  Patient problems: Discomfort; Medical device site infection

  MAUDE report 24377115 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY WAS HOSPITALIZED AFTER INITIAL IMPLANT SURGERY DUE TO SEVERE VERTIGO. NO MEDICAL INTERVENTION OCCURRED. SURGEON CLEARED THE RECIPIENT FOR ACTIVATION AND IT IS NOTED THAT VERTIGO IS NOT DEVICE RELATED.

  Patient problems: Vertigo

  MAUDE report 24329165 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED INFLAMMATION AND PAIN UNDER THE SKIN FOLLOWING INITIAL SURGERY. THE RECIPIENT WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN).

  Patient problems: Implant Pain; Skin Inflammation/ Irritation

  MAUDE report 24324161 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT WAS REPORTEDLY TAKEN TO THE EMERGENCY ROOM A FEW DAYS AFTER IMPLANT DUE TO BLEEDING AT THE INCISION SITE. THE RECIPIENT PRESENTED WITH PAIN/DISCOMFORT. THE INCISION WAS REPORTEDLY REGLUED. AN ULTRASOUND WAS PERFORMED AND REVEALED A SMALL POCKET OF FLUID. THE RECIPIENT'S PAIN WAS REPORTEDLY MANAGEABLE.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 24305060 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A TIP FOLD-OVER. A CT SCAN CONFIRMED THE TIP FOLD-OVER. THE RECIPIENT REPORTEDLY WAS A POOR PERFORMER. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE.

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

  MAUDE report 24254404 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY ELECTING REVISION SURGERY. THE RECIPIENT IS PRESENTING WITH PAIN, NUMBNESS, DIZZINESS, AND FAINTING WITH AND WITHOUT DEVICE USE. THE SURGEON DOES NOT BELIEVE THE ISSUES TO BE DEVICE RELATED. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT IS HEALING WELL.

  Patient problems: Convulsion/Seizure; Dizziness; Numbness; Pain

  MAUDE report 24206403 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE PHYSICIAN REPORTEDLY ADVISED THE RECIPIENT TO CEASE USE OF THE 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

  MAUDE report 24167646 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT WAS REPORTEDLY HOSPITALIZED DUE TO SEVERE DIZZINESS AND EAR PAIN ASSOCIATED WITH A MASTOIDITIS INFECTION. THE RECIPIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS (TYPE UNKNOWN). THE RECIPIENT IS PRESENTING WITH SOUND QUALITY ISSUES. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Dizziness; Ear Pain; Medical device site infection

  MAUDE report 24156857 ↗
• InjuryDec 29, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DIFFICULTY DURING ELECTRODE INSERTION. THE RECIPIENT IS PRESENTING WITH NO SOUND. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 23906807 ↗

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-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-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-1085-2019 · Feb 6, 2019 · Terminated
  Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
• 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-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-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-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-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-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-0759-06 · Mar 8, 2006 · Terminated
  The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H.

…and 1 more.