HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04 (UDI 07630016841002)Recalls & reported problems

All models of HiRes Ultra CI HiFocus MS Electrode (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This HiRes Ultra HiFocus electrode is a cochlear implant electrode. Its 2,907 adverse event reports often describe mechanical problems and impedance problems, with recipients reporting poor sound quality despite testing within normal limits. Some reports mention revision surgery. The reports include no deaths and 264 injuries. No recalls name this device. Reports fell to 93 over the last year, from 217 the year before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 2,918
Deaths reported: 0
Injuries reported: 265
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2,918 adverse event reports that list this exact device (DI 07630016841002), received between Jun 26, 2018 and Sep 30, 2026 — classified as 265 injuries, 2,653 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2,300 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Mechanical Problem2,300
Impedance Problem1,156
Adverse Event Without Identified Device or Use Problem329
Therapeutic or Diagnostic Output Failure324
Output Problem226
Insufficient Device Problem Information191
Appropriate Device Problem Term/Code Not Available189
Output below Specifications113

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1,759
Insufficient Information710
Failure of Implant692
Therapeutic Response, Decreased317
No Clinical Signs, Symptoms or Conditions172
No Known Impact Or Consequence To Patient113
No Information63
Pain63

Recent adverse event reports

The 25 most recent of 2,918 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50953324 ↗
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50953323 ↗
MalfunctionSep 25, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50905536 ↗
MalfunctionSep 25, 2026Mechanical Problem
The recipient is reportedly experiencing decreased performance. A review of the recipient's test data indicated impedance issues. Programming adjustments were made, however, the issue did not resolve. Revision surgery is scheduled.
Patient problems: Insufficient Information
MAUDE report 50897747 ↗
MalfunctionSep 24, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50890813 ↗
MalfunctionSep 24, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50890260 ↗
MalfunctionSep 22, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50860394 ↗
MalfunctionSep 22, 2026Mechanical 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. External equipment was exchanged, however, the issue did not resolve. Revision surgery is scheduled.
Patient problems: Insufficient Information
MAUDE report 50856688 ↗
MalfunctionSep 22, 2026Mechanical Problem
The recipient reportedly experienced decreased performance. A review of the recipient¿s test data indicated impedance issues. Device testing revealed results within normal limits. 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: Insufficient Information
MAUDE report 50854683 ↗
MalfunctionSep 17, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50797065 ↗
MalfunctionSep 8, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50671098 ↗
MalfunctionSep 4, 2026Mechanical Problem; Unstable Impedance
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50600846 ↗
MalfunctionSep 2, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50573464 ↗
MalfunctionAug 31, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50528659 ↗
InjuryAug 28, 2026Expulsion
Patient problems: Unspecified Infection
MAUDE report 50509667 ↗
MalfunctionAug 18, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50300242 ↗
MalfunctionAug 12, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50223319 ↗
InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
The recipient reportedly experienced a hematoma at the implant site in (b)(6) 2026 (exact date unknown). The recipient reportedly underwent a draining procedure.
Patient problems: Hematoma
MAUDE report 50161263 ↗
InjuryAug 4, 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 50132713 ↗
MalfunctionAug 3, 2026Mechanical Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50122672 ↗
MalfunctionJun 15, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT PRESENTED WITH POOR HEARING QUALITY. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS UNDER CONSIDERATION.
Patient problems: Insufficient Information
MAUDE report 25509037 ↗
MalfunctionMay 26, 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 COCHLEAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278458 ↗
MalfunctionMay 18, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT WAS EXPLANTED AND REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25209579 ↗
MalfunctionMay 14, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. REVISION SURGERY IS SCEDULED.
Patient problems: Insufficient Information
MAUDE report 25166978 ↗
MalfunctionMay 11, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS WERE MADE AND RESULTED WITH IMPROVEMENT, HOWEVER, REVISION SURGERY IS SCHEDULED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25144664 ↗

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-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
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

…and 2 more.

Device details

UDI-DI	`07630016841002`
Brand	HiRes™ Ultra CI HiFocus™ MS Electrode
Model	CI-1600-04
Company	Advanced Bionics AG
Product code	MCM · Implant, Cochlear
Class	Class 3
FDA submission	P960058
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	Not in Commercial Distribution
Record updated	Mar 19, 2026

Device type (GMDN): Cochlear implant system, external-microphone

A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Implantation instruments may be packaged with the system.

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All Implant, Cochlear devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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