HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05 (UDI 07630016877988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07630016877988), received between Feb 10, 2021 and Sep 16, 2026 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (7 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Malposition of Device; Adverse Event Without Identified Device or Use Problem

  The recipient reportedly underwent repositioning surgery following initial implant surgery.

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

  MAUDE report 50788323 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT WAS REPORTEDLY HOSPITALIZED DUE TO UNKNOWN REASONS. THE RECIPIENT UNDERWENT AN MRI AND PRESENTED WITH PAIN. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION, ONCE MORE INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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

  MAUDE report 24397770 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING BACTERIAL MENINGITIS. THE RECIPIENT IS PRESENTING WITH DIZZINESS, HEADACHE AND NOISE WITH AND WITHOUT DEVICE USE. THE RECIPIENT WAS PRESCRIBED CORTICOSTEROIDS AND ANTIBIOTICS (TYPE UNKNOWN) ON (B)(6) 2026. ADVANCED BIONICS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Dizziness; Headache; Meningitis

  MAUDE report 24239946 ↗
• InjuryJan 22, 2026Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED FACIAL NERVE STIMULATION WITH DEVICE USE AND DECREASED PERFORMANCE. A CT SCAN CONFIRMED ELECTRODE MIGRATION. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Undesired Nerve Stimulation

  MAUDE report 24154679 ↗
• InjuryDec 29, 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 NOT RE-IMPLANTED. 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; Ear infection

  MAUDE report 23914017 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22913641 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT WAS REPORTEDLY EXPLANTED DUE TO INFECTION. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Unspecified Infection

  MAUDE report 22636518 ↗
• InjuryDec 2, 2024Expulsion; Expulsion

  THE RECIPIENT IS REPORTEDLY EXPERIENCING ELECTRODE EXTRUSION. THE RECIPIENT IS PRESENTING WITH POOR PERFORMANCE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS UNDER CONSIDERATION.

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

  MAUDE report 20819112 ↗
• InjuryNov 26, 2024Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE EXTRUSION CAUSED BY A PSEUDOMONA AERUGINOSA INFECTION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL BE REIMPLANTED AT A LATER DATE. THE RECIPIENT HAS REPORTEDLY HEALED FROM SURGERY, BUT IS STILL BEING TREATED BY ANTIBIOTICS (TYPE UNKNOWN).

  Patient problems: Unspecified Infection

  MAUDE report 20784216 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE ELECTRODE ARRAY WAS REPORTEDLY DAMAGED. 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

  MAUDE report 20504628 ↗
• InjurySep 27, 2024Adverse 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 REPORTEDLY HAD AN EMERGENCY MRI WITHOUT FOLLOWING THE BANDAGING PROTOCOL, AND THE INTERNAL MAGNET CAME OUT OF THE IMPLANT POCKET. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

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

  MAUDE report 20327960 ↗
• InjuryAug 13, 2024Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN DUE TO HEAD TRAUMA, CAUSING THE RECIPIENT TO REFUSE TO WEAR THE DEVICE. TESTING OF THE DEVICE WAS PERFORMED UNDER SEDATION ON (B)(6) 2024. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS.

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

  MAUDE report 19973024 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED INCORRECT ELECTRODE POSITION. REPOSITIONING SURGERY WAS ATTEMPTED, HOWEVER, WAS UNSUCCESSFUL. THE RECIPIENT'S DEVICE WAS THEN 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 18897319 ↗
• MalfunctionFeb 2, 2024Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED A LUMP NEAR THE STITCHES AT IMPLANT SITE. THE SURGICAL WOUND OPENED AND EXPOSED THE INTERNAL DEVICE. THE RECIPIENT'S DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 18636523 ↗
• InjuryNov 1, 2023Mechanical Problem; Intermittent Communication Failure; Mechanical Problem; Intermittent Communication Failure

  THE RECIPIENT REPORTEDLY EXPERIENCED NO SOUND. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. IMAGING CONFIRMED DEVICE PLACEMENT. EXTERNAL EQUIPMENT WAS EXCHANGED AND 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 18051351 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED FACIAL PARALYSIS, TRIGEMINAL NEURALGIA AND INFECTION. THE FACIAL PARALYSIS AND TRIGEMINAL NEURALGIA ARE NOT BELIEVED TO BE DEVICE RELATED. THE RECIPIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Paralysis; Unspecified Infection

  MAUDE report 17814548 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF SOUND FOLLOWING HEAD TRAUMA. THE RECIPIENT RECEIVED MEDICAL TREATMENT AND REMAINED UNDER OBSERVATION. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Head Injury

  MAUDE report 17756397 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANTATION SURGERY, THE ELECTRODE WAS PARTIALLY INSERTED. INTRA-OPERATIVE IMAGING CONFIRMED PARTIAL INSERTION. THE RECIPIENT REPORTEDLY EXPERIENCED INTERMITTENT CONNECTION DURING INITIAL ACTIVATION OF THE DEVICE. X-RAY IMAGINING SHOWED THE ELECTRODE ARRAY OUTSIDE OF THE COCHLEA. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

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

  MAUDE report 17354286 ↗
• InjuryJun 8, 2023Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  ADVANCED BIONICS WAS NOTIFIED 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

  MAUDE report 17086391 ↗
• InjuryJan 12, 2023Expulsion; Migration or Expulsion of Device; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE MIGRATION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED IN THE CONTRALATERAL EAR.

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

  MAUDE report 16152543 ↗
• InjuryOct 25, 2022Positioning Problem

  DURING REIMPLANTATION SURGERY, THE ELECTRODE WAS PARTIALLY INSERTED DUE TO OSSIFICATION. X-RAY INSPECTION CONFIRMED PARTIAL INSERTION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

  Patient problems: Extraskeletal ossification

  MAUDE report 15668170 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED REDNESS, SWELLING, AND DEVICE EXTRUSION. A REVIEW OF TEST SAMPLE INDICATES NO BACTERIAL INFECTION. THE RECIPIENT WAS EXPLANTED.

  Patient problems: Erythema; Skin Erosion; Swelling/ Edema

  MAUDE report 15466326 ↗
• InjuryAug 30, 2022Expulsion; Migration or Expulsion of Device; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED SKIN BREAK DOWN AND DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

  Patient problems: Erosion; Tissue Breakdown

  MAUDE report 15324379 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED BLEEDING FROM EXTERNAL CANAL AFTER IMPLANT SURGERY ON (B)(6) 2021. THE RECIPIENT WAS HOSPITALIZED. THE RECIPIENT PRESENTED WITH HEMORRHAGING IN THE EXTERNAL AUDITORY CANAL ON (B)(6) 2021. THE RECIPIENT WAS GIVEN ANTIBIOTICS WHICH HELPED REDUCE THE BLEEDING. THERE IS NO EVIDENCE THAT THE INFECTION IS DEVICE RELATED. THE RECIPIENT WAS DISCHARGED ON (B)(6) 2021. THE RECIPIENT'S ACTIVATION WENT WELL.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 12081661 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE RECIPIENT'S DEVICE WAS REPORTEDLY EXPLANTED DUE TO MENINGITIS. THE RECIPIENT REMOVED THE STITCHES FOLLOWING INITIAL IMPLANT SURGERY. ADVANCED BIONICS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Meningitis; Skin Infection

  MAUDE report 11307427 ↗

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-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-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-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.