HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04 (UDI 07630016828638)Recalls & reported problems

Summary

The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 07630016828638), received between Jun 29, 2018 and Sep 23, 2026 — classified as 241 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (31 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 315 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Infectious Otitis Media

  MAUDE report 50876185 ↗
• MalfunctionSep 8, 2026Noise, Audible; Patient Device Interaction Problem

  Patient problems: Dizziness

  MAUDE report 50680256 ↗
• InjuryMay 11, 2026Device Dislodged or Dislocated

  THE RECIPIENT REPORTEDLY EXPERIENCED A DISPLACED MAGNET. THE RECIPIENT UNDERWENT SURGERY WHERE THE MAGNET WAS SUCCESSFULLY PUSHED BACK INTO PLACE.

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

  MAUDE report 25145108 ↗
• MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING AN EQUILIBRIUM PROBLEM THAT RESTARTED AFTER USING NEW EXTERNAL EQUIPMENT. THE RECIPIENT WAS ADVISED TO STOP USING THE DEVICE.

  Patient problems: Dizziness

  MAUDE report 24926099 ↗
• InjuryApr 13, 2026Device Dislodged or Dislocated

  THE RECIPIENT REPORTEDLY EXPERIENCED MAGNET DISPLACEMENT FOLLOWING AN MRI, DUE TO THE BANDAGE PROTOCOL NOT BEING FOLLOWED. THE MAGNET WAS SUCCESSFULLY REPOSITIONED THROUGH EXTERNAL MANIPULATION. THE RECIPIENT EXPERIENCED SOME PAIN, WHICH HAS SINCE RESOLVED, AND THE DEVICE IS NOW FUNCTIONING PROPERLY.

  Patient problems: Pain

  MAUDE report 24866824 ↗
• InjuryFeb 24, 2026Migration or Expulsion of Device; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE EXTRUSION. IN (B)(6) 2025, THE RECIPIENT PRESENTED WITH SWELLING, CRUSTING AND TENDERNESS: HOWEVER, THE RECIPIENT DID NOT FOLLOW UP. AS A RESULT, THE DEVICE EXTRUDED THROUGH THE SKIN. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

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

  MAUDE report 24437554 ↗
• MalfunctionFeb 20, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE COMPANY WAS INFORMED 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24408140 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND SWELLING AT THE MAGNET SITE. THE RECIPIENT PRESENTED WITH LIQUID BUILD UP OVER THE MAGNET SITE AS WELL AS TENDERNESS. THE RECIPIENT WAS ADMITTED TO THE HOSPITAL AND WILL BE UNDERGOING TESTING TO DETERMINE CAUSE. IT IS NOTED THAT THE RECIPIENT HAS A SHUNT ON THIS SAME SAID; HOWEVER, IT IS NOT RELATED TO THE DEVICE.

  Patient problems: Fluid Discharge; Hematoma; Pain; Swelling/ Edema

  MAUDE report 24221382 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION. 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: Unspecified Infection

  MAUDE report 24209285 ↗
• MalfunctionJan 22, 2026Loose or Intermittent Connection; Intermittent Communication Failure

  THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 24156568 ↗
• MalfunctionJan 19, 2026Mechanical Problem; Electrical Shorting

  THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. DURING THE PROGRAMMING SESSION IT WAS NOTED THAT THE DEVICE HAD SHORTED ELECTRODES. 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; Insufficient Information

  MAUDE report 24112064 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND SWELLING FOLLOWING AN MRI. THE BANDAGE PROTOCOL WAS REPORTEDLY NOT FOLLOWED. THE RECIPIENT WAS REPORTEDLY PRESCRIBED PAIN MEDICATION (TYPE: UNKNOWN). ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23917576 ↗
• InjuryDec 15, 2025Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED SKIN BREAKDOWN AND INFECTION DUE TO DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL REPORTEDLY BE REIMPLANTED AT A LATER TIME. THE RECIPIENT'S INFECTION HAS RESOLVED.

  Patient problems: Medical device site infection; Necrosis; Skin Infection

  MAUDE report 23802454 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT WAS REPORTEDLY A NON-USER OF THE DEVICE DUE TO COGNITIVE IMPAIRMENT. THE RECIPIENT PRESENTED WITH MULTIPLE EPISODES OF INFECTION (MIDDLE EAR OTITIS) AND DEVELOPED A CHOLESTEATOMA. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED. THE RECIPIENT IS RECOVERING WELL.

  Patient problems: Cholesteatoma; Infectious Otitis Externa; Medical device site infection

  MAUDE report 23757944 ↗
• InjuryNov 26, 2025Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. ONCE ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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

  MAUDE report 23658109 ↗
• MalfunctionNov 18, 2025Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN WITH DEVICE USE. THE RECIPIENT CEASED DEVICE USE. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS SCHEDULED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 23585877 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT WAS NOT RECEIVING ANY BENEFIT FROM THE DEVICE AND STOPPED USING THE DEVICE. THE RECIPIENT WAS RECOMMENDED TO DISCONTINUE DEVICE USE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. ONCE MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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

  MAUDE report 23575435 ↗
• InjuryAug 15, 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. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING FURTHER INFORMATION; ONCE MORE INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Cholesteatoma; Medical device site infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 22820119 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE COMPANY WAS INFORMED THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT. 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 22700574 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY ELECTING REVISION SURGERY FOR A TECHNOLOGY UPGRADE TO A MRI COMPATIBLE DEVICE. REVISION SURGERY IS SCHEDULED.

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

  MAUDE report 22686236 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY ELECTING EXPLANT SURGERY DUE TO HEALTH ISSUES UNRELATED THE DEVICE AND THE NEED FOR AN MRI. THE RECIPIENT REPORTEDLY DOES NOT RECEIVE GOOD BENEFIT FROM THE DEVICE. SURGERY IS SCHEDULED.

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

  MAUDE report 22649036 ↗
• InjuryJul 23, 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. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. ONCE 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 22580144 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY ELECTING EXPLANT SURGERY FOR TECHNOLOGY UPGRADE DUE TO MRI NEEDS. MRI NEEDS ARE NOT DEVICE RELATED. REVISION SURGERY HAS BEEN SCHEDULED.

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

  MAUDE report 22370473 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE AND EXTERNAL EQUIPMENT WAS EXCHANGED: HOWEVER, THE ISSUES DID NOT RESOLVE. REVISION SURGERY HAS BEEN SCHEDULED.

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

  MAUDE report 22346031 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN POST AURICULAR ABSCESS. IN (B)(6) 2016, THE RECIPIENT WAS HOSPITALIZED. THE RECIPIENT UNDERWENT AN ABSCESS DRAINAGE PROCEDURE WITH PLACEMENT OF TYMPANOSTOMY TUBE. THE RECIPIENT WAS PRESCRIBED WITH ANTIBIOTICS (TYPES UNKNOWN). DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. THE RECIPIENT HAS HEALED.

  Patient problems: Abscess

  MAUDE report 22338349 ↗

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-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-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-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-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.