HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05 (UDI 07630016855696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 07630016855696), received between Jun 21, 2019 and Sep 21, 2026 — classified as 25 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (155 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 178 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Mechanical 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: Insufficient Information

  MAUDE report 50845839 ↗
• InjuryApr 7, 2026Mechanical Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

  Patient problems: Pain

  MAUDE report 24801197 ↗
• MalfunctionMar 17, 2026Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 24619767 ↗
• MalfunctionMar 12, 2026Mechanical Problem; Patient Device Interaction Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, AND THE RECIPIENT NOTED IMPROVEMENT. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582248 ↗
• MalfunctionDec 23, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879641 ↗
• MalfunctionDec 22, 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 23873512 ↗
• MalfunctionDec 22, 2025Mechanical Problem; Mechanical Problem

  A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 23872106 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THE RECIPIENT'S DEVICE WAS EXPLANTED. DEVICE TESTING HAD REVEALED RESULTS WITHIN NORMAL LIMITS. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

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

  MAUDE report 23802455 ↗
• MalfunctionDec 3, 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. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 23710653 ↗
• MalfunctionNov 14, 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

  MAUDE report 23560212 ↗
• MalfunctionOct 21, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353817 ↗
• MalfunctionOct 20, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE AND SOUND QUALITY ISSUES. 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 23337587 ↗
• MalfunctionSep 17, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use 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 23080465 ↗
• InjurySep 17, 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. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 23080070 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY HAS BEEN SCHEDULED.

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

  MAUDE report 22938430 ↗
• MalfunctionAug 29, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical 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 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; Failure of Implant

  MAUDE report 22927137 ↗
• MalfunctionAug 18, 2025Mechanical Problem; Mechanical Problem

  A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. 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 22834144 ↗
• MalfunctionJul 7, 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 HAS BEEN 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 22424573 ↗
• MalfunctionJun 6, 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 22161973 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES 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 22141340 ↗
• MalfunctionMay 30, 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 22114383 ↗
• MalfunctionMay 29, 2025Mechanical Problem; Mechanical Problem

  A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT IS EXPERIENCING NO BENEFIT AND TINNITUS. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 22110782 ↗
• MalfunctionMay 27, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES 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 22090057 ↗
• MalfunctionMay 27, 2025Mechanical Problem; Mechanical Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE AND SOUND QUALITY ISSUES. A REVIEW OF THE RECIPIENT'S 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 22090055 ↗
• MalfunctionMay 22, 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

  MAUDE report 22069000 ↗

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-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
• 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

…and 2 more.