Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant Z246604Recalls & reported problems
Cochlear Limited · N/A · Class 3 · Implant
All models of Cochlear Nucleus Implant (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cochlear Nucleus auditory brainstem implant is an implanted device that sends sound signals directly to the brainstem. The 33 reports describe hearing loss or unwanted stimulation such as shocking sensations, dizziness and nausea, implant-site infections, and problems during MRI scans where the magnet shifted or had to be removed. All33 reports involve injuries and none report a death. No recalls name this device.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 09321502020404), received between Oct 10, 2016 and Jun 30, 2026 — classified as 33 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 reports).
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
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available17
- Adverse Event Without Identified Device or Use Problem7
- Migration or Expulsion of Device3
- Defibrillation/Stimulation Problem2
- Failure to Deliver Shock/Stimulation2
- Inappropriate/Inadequate Shock/Stimulation2
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Code Available5
- Unspecified Infection5
- Hearing Impairment4
- No Clinical Signs, Symptoms or Conditions4
- Deafness2
- Dizziness2
- Impaired Healing2
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Device Dislodged or Dislocated
PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT DURING AN MRI AFTER THE MANUFACTURER'S MRI INSTRUCTIONS FOR USE (IFU) WERE NOT FOLLOWED. THE PATIENT UNDERWENT THE MRI WITH THE IMPLANT MAGNET STILL IN PLACE DUE TO A MISUNDERSTANDING REGARDING THE USE OF A NON-MAGNETIC PLUG. A REVISION PROCEDURE WAS SUBSEQUENTLY PERFORMED (DATE NOT REPORTED) TO REMOVE THE MAGNET BEDSIDE. AT THE TIME OF REPORTING, THE IMPLANTED DEVICE REMAINED IN SITU, AND THE CLINICAL TEAM WAS EVALUATING WHETHER TO REPLACE THE MAGNET OR USE A NON-MAGNETIC PLUG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25662606 ↗InjuryMay 4, 2026Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation
PER THE CLINIC, THE PATIENT EXPERIENCED MINIMAL TO ABSENT AUDITORY PERCEPTION AND NON-AUDTORY STIMULATION SUCH AS SHOCKING SENSATION, DIZZINESS AND NAUSEA, DURING IMPLANT REACTIVATION. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2026. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Dizziness; Nausea
MAUDE report 25076129 ↗InjuryMay 4, 2026Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation
PER THE CLINIC, THE PATIENT EXPERIENCED MINIMAL TO ABSENT AUDITORY PERCEPTION AND NON-AUDITORY STIMULATION SUCH AS SHOCKING SENSATION, DIZZINESS AND NAUSEA, DURING IMPLANT REACTIVATION. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2026. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Dizziness; Nausea
MAUDE report 25076128 ↗InjuryApr 10, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE INFECTION WAS LOCATED AT THE IMPLANT SITE.
Patient problems: Impaired Healing; Medical device site infection; Unspecified Infection
MAUDE report 24842472 ↗InjuryApr 10, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, DUE TO AN INFECTION (SITE OF INFECTION NOT CONFIRMED) AND THE PATIENT ALSO NO LONGER USING THE DEVICE. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing; Medical device site infection; Unspecified Infection
MAUDE report 24838174 ↗InjuryJan 12, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON DECEMBER 08, 2025, DUE TO MRI IS NEEDED FOR OTHER HEALTH ISSUE. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24033885 ↗InjuryJan 12, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO MRI IS NEEDED FOR OTHER HEALTH ISSUE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24033815 ↗InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (SITE OF THE INFECTION IS UNKNOWN I.E. IF IT IS DEVICE RELATED. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE IN THE SAME PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 14682506 ↗InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (SITE OF THE INFECTION IS UNKNOWN I.E. IF IT IS DEVICE RELATED. THE DEVICE WAS EXPLANTED ON (B)(6) 2022. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE IN THE SAME PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 14682504 ↗InjuryMar 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2021. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Patient problems: Hearing Impairment
MAUDE report 13851349 ↗InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2022 DUE TO DEVICE NON-USE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577785 ↗InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2022 DUE TO DEVICE NON-USE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577782 ↗InjuryAug 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT COULD NOT RECEIVE AUDITORY SENSATION WITH THE DEVICE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021, IN ORDER TO REPOSITION THE DEVICE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12305671 ↗InjuryAug 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT COULD NOT RECEIVE AUDITORY SENSATION WITH THE DEVICE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021, IN ORDER TO REPOSITION THE DEVICE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12305670 ↗InjuryJul 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
PER THE CLINICIAN, THE DEVICE WAS EXPLANTED ON (B)(6) 2017, DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 12148423 ↗InjuryJul 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
PER THE CLINICIAN, THE DEVICE WAS EXPLANTED ON (B)(6) 2017, DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 12148421 ↗InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE SURGEON EXPERIENCED POOR HEARING FUNCTION. THE DEVICE WAS EXPLANTED (DATE UNKNOWN). THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT.
Patient problems: Hearing Impairment
MAUDE report 12081782 ↗InjuryMay 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021 DUE TO NO LONGER RECEIVING BENEFIT FROM THE DEVICE. IT IS UNKNOWN IF THE PATIENT HAS REIMPLANTED WITH A NEW DEVICE AS OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11847164 ↗InjuryMay 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021 DUE TO NO LONGER RECEIVING BENEFIT FROM THE DEVICE. IT IS UNKNOWN IF THE PATIENT HAS REIMPLANTED WITH A NEW DEVICE AS OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11847161 ↗InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED NON-AUDITORY SENSATIONS IN THE BACK AND LEGS, WITH DEVICE USE. DURING A REVISION SURGERY TO REPOSITION THE IMPLANT ON (B)(6) 2021, THE ELECTRODE WAS INADVERTENTLY CUT. A DECISION WAS MADE TO EXPLANT THE DEVICE. THE PATIENT HAS NOT BEEN REIMPLANTED WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11457731 ↗InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED NON-AUDITORY SENSATIONS IN THE BACK AND LEGS, WITH DEVICE USE. DURING A REVISION SURGERY TO REPOSITION THE IMPLANT ON (B)(6) 2021, THE ELECTRODE WAS INADVERTENTLY CUT. A DECISION WAS MADE TO EXPLANT THE DEVICE. THE PATIENT HAS NOT BEEN REIMPLANTED WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11457717 ↗InjuryOct 31, 2019Expulsion; Expulsion
PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT DURING AN MRI (1.5 TESLA). THE PATIENT'S HEAD WAS WRAPPED AS AN APPROVED INDICATION IN EUROPE. SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED (B)(6) 2019.
Patient problems: No Code Available
MAUDE report 9263971 ↗InjuryAug 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT WAS EXPLANTED ON (B)(6) 2019 BECAUSE OF A SUSPECTED DEVICE FAILURE. THE PATIENT WAS RE-IMPLANTED WITH A DEVICE AT THE SAME SURGERY.
Patient problems: No Code Available
MAUDE report 8886221 ↗InjuryJun 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT WAS EXPLANTED ON (B)(6) 2019 BECAUSE OF A SUSPECTED DEVICE FAILURE. THE PATIENT WAS RE-IMPLANTED WITH A DEVICE AT THE SAME SURGERY.
Patient problems: No Code Available
MAUDE report 8706509 ↗InjuryMay 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED PAIN AND FLUID BUILDUP UNDER THE SKIN FLAP AND SUBSEQUENTLY WAS HOSPITALISED IN (B)(6) 2019 TO DRAIN THE FLUID AND PLACE A SHUNT.
Patient problems: Pain; Swelling
MAUDE report 8656911 ↗
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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