HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05 (UDI 00840094456020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 00840094456020), received between May 9, 2023 and Sep 25, 2026 — classified as 1 death, 243 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Migration” (86 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 257 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Purulent Discharge

  MAUDE report 50905537 ↗
• InjurySep 25, 2026Patient Device Interaction Problem

  Patient problems: Vertigo

  MAUDE report 50904593 ↗
• InjurySep 23, 2026Malposition of Device

  Patient problems: Insufficient Information

  MAUDE report 50863004 ↗
• InjurySep 22, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50862896 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  The recipient is reportedly experiencing skin breakdown, redness at magnet site and fluctuating performance. The external equipment has been exchanged, magnet strength has been reviewed, along with adding moleskin and receiving steroid injections with no improvement. The recipient is reportedly using the device intermittently. Revision surgery is scheduled.

  Patient problems: Skin Erosion

  MAUDE report 50858241 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  The recipient is reportedly experiencing pain around the implant site with fluctuating performance. The external equipment has been exchanged, magnet strength has been reviewed, along with adding moleskin and receiving steroid injections with no improvement. The recipient is reportedly using the device intermittently.

  Patient problems: Pain

  MAUDE report 50857762 ↗
• InjurySep 15, 2026Migration

  The recipient is reportedly experiencing electrode migration. A CT scan confirmed electrode migration. Programming adjustments were made. Revision surgery has been scheduled.

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

  MAUDE report 50779674 ↗
• InjurySep 15, 2026Migration

  The recipient is reportedly experiencing migration due to manipulating the device under the skin. The recipient is presenting with pain and discomfort. Revision surgery is scheduled.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 50779223 ↗
• MalfunctionSep 8, 2026Migration

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

  MAUDE report 50675458 ↗
• InjuryAug 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50510272 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Dizziness

  MAUDE report 50506010 ↗
• MalfunctionAug 20, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50359016 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  The recipient's initial implant surgery time was extended due to ossification and otosclerosis. The surgeon had to perform a cochleostomy. The recipient was successfully implanted and activated.

  Patient problems: Extraskeletal ossification

  MAUDE report 50207827 ↗
• InjuryAug 11, 2026Impedance Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the recipient experienced a Cerebrospinal fluid (CSF) leak during initial implant surgery. A review of the test data indicated impedance issues. NRI recordings were abnormal and difficult to interpret due to abnormal morphology.

  Patient problems: Cerebrospinal Fluid Leakage; Deformity/ Disfigurement

  MAUDE report 50204435 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED ELECTRODE MIGRATION FOLLOWING INITIAL IMPLANT SURGERY. THE SURGEON ATTEMPTED TO RE-ADVANCE THE ARRAY, BUT WAS UNABLE TO DO SO. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE RECIPIENT'S DEVICE WAS SUCCESSFULLY ACTIVATED.

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

  MAUDE report 25593284 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT EXPERIENCED A HEAD TRAUMA INCIDENT. THE RECIPIENT PRESENTED WITH SOME SWELLING OVER THE IMPLANT SITE. DEVICE TESTING WAS COMPLETED AND WAS WITHIN NORMAL LIMITS. A CT SCAN WAS COMPLETED, HOWEVER DIFFICULT TO INTERPRET DUE TO SKULL FRACTURE. THE RECIPIENT COMPLETED A COURSE OF ANTIBIOTICS.

  Patient problems: Head Injury; Swelling/ Edema

  MAUDE report 25563375 ↗
• InjuryJun 4, 2026Migration

  THE RECIPIENT IS REPORTEDLY EXPERIENCING POOR PERFORMANCE. A CT SCAN CONFIRMED ELECTRODE MIGRATION. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 25400342 ↗
• InjuryMay 28, 2026Expulsion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

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

  MAUDE report 25315822 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECENTLY IMPLANTED RECIPIENT DEVELOPED AN INFECTION THAT REQUIRED TREATMENT ONE ROUND OF ANTIBIOTICS (TYPE UNKNOWN).

  Patient problems: Post Operative Wound Infection

  MAUDE report 25221554 ↗
• InjuryMay 4, 2026Difficult or Delayed Positioning; Migration

  THE RECIPIENT REPORTEDLY HAD OSSIFICATION WHICH MADE ELECTRODE INSERTION MORE DIFFICULT. HOWEVER, THE OVERALL SURGERY TIME WAS NOT SIGNIFICANTLY PROLONGED DESPITE THE DIFFICULTY. AT INITIAL ACTIVATION, THE RECIPIENT REPORTED NO AUDITORY PERCEPTION. CT IMAGING CONFIRMED ELECTRODE MIGRATION. THE RECIPIENT'S DEVICE WAS EXPLANTED AND REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

  Patient problems: Extraskeletal ossification

  MAUDE report 25071982 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AFTER INITIAL IMPLANT. THE RECIPIENT'S INFECTION WAS TREATED AND RESOLVED. THE RECIPIENT WAS SUCCESSFULLY ACTIVATED. ADVANCED BIONICS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 24984368 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT IS REPORTEDLY EXPERIENCING ELECTRODE MIGRATION. CT SCAN HAS CONFIRMED ELECTRODES OUTSIDE THE COCHLEA. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 24960466 ↗
• InjuryApr 20, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration

  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

  MAUDE report 24933789 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK DURING IMPLANT SURGERY, WHICH WAS MANAGED INTRAOPERATIVELY, PROLONGING THE PROCEDURE BY APPROXIMATELY 15 MINUTES. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24866820 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK DURING IMPLANT SURGERY, WHICH WAS MANAGED INTRAOPERATIVELY, PROLONGING THE PROCEDURE BY APPROXIMATELY 15 MINUTES. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24866819 ↗

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-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-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-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-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

…and 2 more.