Nucleus Z190574Recalls & reported problems

Summary

The FDA's MAUDE database contains 981 adverse event reports that list this exact device (DI 09321502020268), received between Dec 4, 2013 and Sep 29, 2026 — classified as 858 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Expulsion” (109 reports).

3 other recalls cover devices cleared under the same FDA submission (P970051); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 981 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Implant Pain

  MAUDE report 50927680 ↗
• InjurySep 28, 2026Migration

  Per the clinic, the patient experienced pain in the pinna due to implanted device migration. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Pain

  MAUDE report 50910920 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated

  Per the clinic, the patient experienced a magnet dislodgement from an unknown cause (specific date not reported) and the patient underwent a surgical procedure on (b)(6) 2026. During the surgery, it was observed that the silicone had torn and the magnet was displaced leading to the decision to explant the device. The patient was re-implanted with a new device during the same surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836317 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated

  Per the clinic, the patient experienced a magnet dislodgement from an unknown cause (specific date not reported) and the patient underwent a surgical procedure on (b)(6) 2026. During the surgery, it was observed that the silicone had torn and the magnet was displaced leading to the decision to explant the device. The patient was re-implanted with a new device during the same surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836309 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted on (specific date not reported) for unknown reasons.It is unknown if there are plans to reimplant the patient 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: Insufficient Information

  MAUDE report 50835365 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted on (specific date not reported) for unknown reasons.It is unknown if there are plans to reimplant the patient 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: Insufficient Information

  MAUDE report 50835361 ↗
• MalfunctionSep 1, 2026Circuit Failure; High impedance; Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced high impedance with some electrodes and poor performance with implanted device. Troubleshooting and hardware exchange attempts were made; however, the issue could not be resolved. The implanted device remains. It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report. Additional information has been requested but it 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 50536364 ↗
• InjuryAug 26, 2026Device Dislodged or Dislocated

  Per the clinic the patient experienced a dislodged magnet during an MRI (1.5 Tesla) performed on (b)(6) 2026; However, the clinician did not follow the manufacturer's instructions for use of MRI. Subsequently, a revision surgery to remove and replace the magnet was completed on (b)(6) 2026. The implanted device remains.

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

  MAUDE report 50445839 ↗
• InjuryAug 5, 2026Device Dislodged or Dislocated

  Per the clinic the patient experienced a magnet dislodgement due to a collision which was discovered through a CT scan (date not specified). The patient underwent revision surgery to perform magnet repair on (b)(6) 2026, where it was discovered silicon capsule has been ruptured. Subsequently, the device was explanted on (b)(6) 2026, The patient was re-implanted with another cochlear device during the same surgery.

  Patient problems: Head Injury

  MAUDE report 50137877 ↗
• InjuryAug 3, 2026Expulsion

  Per the clinic, the patient experienced extrusion of the electrode lead into the external auditory canal due to chronic otitis media. Subsequently, 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: Cyst(s); Infectious Otitis Media

  MAUDE report 50122647 ↗
• InjuryAug 3, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced skin flap infection subsequent to sustaining a head trauma (specific date not reported). Eventually, the patient was explanted on (b)(6) 2026 and reimplanted with another cochlear device during the same surgery.

  Patient problems: Head Injury; Skin Infection

  MAUDE report 50111571 ↗
• InjuryJul 30, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced pain and infection (cellulitis) at implant site. Subsequently, the patient was treated with oral antibiotics (specific date and duration not reported), however, the issue did not resolve. The device was explanted on (b)(6) 2026, and it is unknown if there are plans to reimplant the patient as of the date of this report.

  Patient problems: Cellulitis; Implant Pain; Medical device site infection

  MAUDE report 50078287 ↗
• InjuryJun 28, 2026Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE IMPLANT. SUBSEQUENTLY, THE PATIENT UNDERWENT A LOCAL WOUND CARE FOR A DURATION OF 8 WEEKS AND WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTIC (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED, AND THE DEVICE WAS EXPLANTED ON (B)(6) 2026. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Tissue Breakdown

  MAUDE report 25648529 ↗
• InjuryJun 5, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGMENT FROM ITS POCKET. SUBSEQUENTLY, SURGERY WAS PERFORMED ON (B)(6) 2026, UNDER GENERAL ANESTHESIA TO REMOVE AND REPLACE THE IMPLANT MAGNET. THE IMPLANTED DEVICE REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409399 ↗
• MalfunctionJun 5, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGMENT FROM ITS POCKET. SUBSEQUENTLY, SURGERY WAS PERFORMED ON (B)(6) 2026, UNDER GENERAL ANESTHESIA TO REMOVE AND REPLACE THE IMPLANT MAGNET. THE IMPLANTED DEVICE REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409390 ↗
• InjuryApr 30, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (SITE OF INFECTION NOT CONFIRMED) AND CHOLESTEATOMA. THE PATIENT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS IN 2019 AND ORAL ANTIBIOTICS IN 2020 (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 FOR A CHOLESTEATOMA REMOVAL AND BLIND SAC CLOSURE, AND A SECOND REVISION SURGERY ON (B)(6) 2020 FOR A MASTOID CAVITY DRAINAGE AND WASHOUT. THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6) 2021.

  Patient problems: Cyst(s); Unspecified Infection

  MAUDE report 25039790 ↗
• InjuryApr 9, 2026Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE RECEIVER/STIMULATOR, RESULTING IN EXPOSURE OF THE DEVICE THROUGH THE SKIN. THE PATIENT ALSO REPORTED OCCASIONAL MILD PAIN AND NUISANCE AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Implant Pain; Tissue Breakdown

  MAUDE report 24826765 ↗
• InjuryApr 9, 2026Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE RECEIVER/STIMULATOR, RESULTING IN EXPOSURE OF THE DEVICE THROUGH THE SKIN. THE PATIENT ALSO REPORTED OCCASIONAL MILD PAIN AND NUISANCE AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Implant Pain; Tissue Breakdown

  MAUDE report 24826764 ↗
• InjuryApr 1, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE AND NOT RECEIVING BENEFIT FROM THE DEVICE WITH THE DEVICE SINCE ONSET. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. THE PATIENT WAS NOT RE-IMPLANTED.

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

  MAUDE report 24751389 ↗
• InjuryFeb 19, 2026Expulsion

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO THE EXTRUSION OF RECEIVER/STIMULATOR. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

  Patient problems: Tissue Breakdown

  MAUDE report 24388766 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT REQUIRES MULTIPLE MRI REQUIREMENTS DUE TO OTHER MEDICAL CONDITION. THE PATIENT ALSO STATED THAT THE REQUIRED SAFETY PROCEDURE OF SPLINTING AND HEADWRAPPING IS INTOLERABLE RESULTING IN THE DECISION TO EXPLANT THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER MRI COMPATIBLE COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332443 ↗
• InjuryFeb 13, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT WAS IDENTIFIED AS HAVING THE BRCA1 GENE MUTATION, WHICH MAY LEAD TO THE DEVELOPMENT OF BREAST CANCER AND REQUIRES ONGOING MONITORING VIA MRI IMAGING. ALTHOUGH THE IMPLANTED DEVICE USED BY THE PATIENT IS MRI-CONDITIONAL, THE PATIENT FOUND THE REQUIRED SAFETY PROCEDURES, INCLUDING SPLINTING AND HEAD WRAPPING, TO BE INTOLERABLE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH A NEW MRI-COMPATIBLE COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331167 ↗
• InjuryFeb 13, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED WOUND INFECTION (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE DEVICE WAS EXPLANTED IN (B)(6) 2017 (SPECIFIC DATE NOT REPORTED) AND THE ELECTRODE IS LEFT IN-SITU IN THE COCHLEA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Wound Infection

  MAUDE report 24329917 ↗
• InjuryFeb 4, 2026Circuit Failure; Failure to Deliver Shock/Stimulation; Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED SHARP EAR PAIN. ON (B)(6) 2026; THE PATIENT WAS SEDATED FOR THE EARWAX REMOVAL AND DUE TO THE PROFESSIONAL'S MANIPULATION OF THE EXTERNAL EAR LEADS TO EXTRUSION OF THE ELECTRODE, NON-AUDITORY STIMULATION AND OPEN CIRCUITS WERE NOTED ON ALL ELECTRODES. HOWEVER, THIS DID NOT ALLEVIATE THE PROBLEM RESULTING IN A DECISION TO EXPLANT THE DEVICE. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Ear Pain

  MAUDE report 24258298 ↗
• MalfunctionJan 29, 2026Circuit Failure; Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DURING AN EMERGENCY MRI (1.5 TESLA) PROCEDURE. HOWEVER, THE CLINICIAN DID NOT FOLLOW THE MANUFACTURER'S INSTRUCTIONS FOR USE OF MRI SINCE IT WAS AN EMERGENCY MRI. IT WAS ALSO REPORTED THAT OPEN CIRCUITS WERE NOTED ON 16 ELECTRODES. SUBSEQUENTLY, A SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218924 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970051. One submission often covers many models, so check the product and lot details in each record.

• Z-2155-2015 · Jun 5, 2015 · Terminated
  Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, t
• Z-0003-2012 · Sep 16, 2011 · Terminated
  Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant
• Z-0119-2010 · Sep 30, 2009 · Terminated
  Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.