Nucleus Z60353Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,815 adverse event reports that list this exact device (DI 09321502007320), received between Sep 9, 2014 and Sep 29, 2026 — classified as 2 deaths, 1,672 injuries, 141 malfunctions.

The most frequently reported specific device problem is “Expulsion” (240 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 1,815 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area

  Per the clinic, the patient experienced a facial nerve stimulation and TIMs results indicating electrical cross talk. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6), 2026. The patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Twitching

  MAUDE report 50927654 ↗
• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area

  Per the clinic, the patient experienced a facial nerve stimulation and TIMs results indicating electrical cross talk. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6) 2026. The patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Twitching

  MAUDE report 50927644 ↗
• InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced pain around the implant site without external sound processor but worse with the device worn. The pain was continuous and worse with palpation due to high sensitivity. Subsequently, the patient was administered with oral antibiotics for a week (specific date not reported). The implanted device remains.

  Patient problems: Implant Pain

  MAUDE report 50893139 ↗
• InjurySep 21, 2026Expulsion

  Per the clinic, the patient experienced an extrusion of the electrode lead into the external auditory canal. There are plans to perform a revision surgery for this patient.; however, this has not occurred 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50836285 ↗
• InjurySep 21, 2026Expulsion

  Per the clinic, the patient experienced an extrusion of the electrode lead into the external auditory canal. There are plans to perform a revision surgery for this patient.; however, this has not occurred 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50836284 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted on (b)(6) 2026, in order for the patient to upgrade to a newer technology. Re-implantation is planned but had not taken place at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835152 ↗
• InjurySep 10, 2026Failure to Deliver Shock/Stimulation

  Per the clinic, the device was explanted on (b)(6) 2026 due to no benefit from the device.

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

  MAUDE report 50715995 ↗
• InjurySep 8, 2026Therapy Delivered to Incorrect Body Area; Output Problem; Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced non-auditory stimulation and poor performance with the device. It was also reported that the patient experienced pain, buzzing, and facial nerve stimulation, which led to inconsistent use of the device. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6) 2026, and the patient was re-implanted with another cochlear device during the same surgery.

  Patient problems: Discomfort; Implant Pain; Inappropriate Device Stimulation of Tissue

  MAUDE report 50662312 ↗
• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient has experienced recurring pain and tingling sensations associated with the device since (b)(6) 2024. The patient also reportedly experienced a head impact. The patient was then treated with painkillers. Imaging confirmed the position of the electrode array and implant magnet, and an effusion was noted at the implant site. Reprogramming and troubleshooting at the clinic did not resolve the issue. Subsequently, the device was explanted on (b)(6) 2026. Re-implantation is planned but had not taken place at the time of this report.

  Patient problems: Head Injury; Pain

  MAUDE report 50659306 ↗
• InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic the device was explanted on (b)(6) 2026, due to cholesteatoma. The patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Cyst(s)

  MAUDE report 50558994 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404154 ↗
• InjuryJul 31, 2026Output Problem; Noise, Audible

  Per the clinic, the patient experienced persistent non-auditory sensation throughout the head and high-pitched tinnitus with and without stimulation from the implanted device, head heaviness and intermittent episodes of dizziness (vertigo) since (b)(6)2026. The patient was admitted to the hospital on (b)(6)2026 for evaluation of these symptoms. Troubleshooting attempts were made; however, the issue could not be resolved. The implanted device remains.

  Patient problems: Dizziness; Tinnitus; Vertigo

  MAUDE report 50095901 ↗
• InjuryJul 29, 2026Inadequacy of Device Shape and/or Size; Expulsion

  Per the clinic, the patient experienced pain/non-auditory sensations with the device and wound healing issues at the implant site, resulting in partial exposure of the implant body. It was also reported that, the wound issue was related to a magnet that was too strong, which caused the skin above the implant to open. Subsequently, the device was explanted with revision of the implant bed on (b)(6) 2026. There are no plans to re-implant the patient with a new device as of the date of this report.

  Patient problems: Impaired Healing; Pain; Tissue Breakdown

  MAUDE report 50065691 ↗
• InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced tenderness and swelling around the implant site and was prescribed with antibiotics (specific date, duration and type not reported). The implanted device remains.

  Patient problems: Swelling/ Edema

  MAUDE report 50011491 ↗
• InjuryJun 28, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED STABBING PAIN AROUND THE MAGNET SITE LEADING TO DEVICE NON-USE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) AND PAIN MEDICATIONS. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Implant Pain

  MAUDE report 25648518 ↗
• MalfunctionJun 25, 2026Circuit Failure; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED DECREASED SPEECH PERCEPTION, PROGRESSIVELY FLUCTUATING OPEN CIRCUITS OVERTIME AND POOR PERFORMANCE WITH THE DEVICE. THE PATIENT REPORTED A FALL IN (B)(6) 2025 (SPECIFIC DATE NOT REPORTED); HOWEVER, NO HEAD INJURY WAS REPORTED. THE PROGRESSIVELY FLUCTUATING OPEN CIRCUITS HAD BEEN IDENTIFIED PRIOR TO THE FALL. HARDWARE EXCHANGE AND TROUBLESHOOTING 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 REIMPLANT THE PATIENT WITH ANOTHER COCHLEAR DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Fall; Stroke/CVA

  MAUDE report 25617839 ↗
• InjuryJun 11, 2026Unexpected Therapeutic Results; Electrical Shorting; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED PERFORMANCE AND SOUND QUALITY DECREMENT OVER THE YEARS. SHORT CIRCUITS WERE NOTED ON TWO ELECTRODES. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL IN ALLEVIATING THE ISSUE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

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

  MAUDE report 25466270 ↗
• InjuryJun 5, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED HEADACHE LEADING TO THE DECISION TO EXPLANT THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Headache

  MAUDE report 25403968 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) DUE TO UNSPECIFIED REASON, AND THE PATIENT WAS REIMPLANTED ON (B)(6) 2026. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25273556 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) DUE TO UNSPECIFIED REASON, AND THE PATIENT WAS REIMPLANTED ON (B)(6) 2026. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25273555 ↗
• InjuryMay 22, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT IMPLANT SITE AND WAS TREATED WITH ANTIBIOTICS (TYPE, DATE AND DURATION NOT REPORTED), HOWEVER, THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Medical device site infection

  MAUDE report 25252196 ↗
• InjuryMay 19, 2026Insufficient Device Problem Information

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2026, DUE TO SUSPECTED DEVICE FAILURE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25212343 ↗
• InjuryMay 19, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026 DUE TO CHOLESTEATOMA. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

  Patient problems: Cyst(s)

  MAUDE report 25212332 ↗
• InjuryMay 14, 2026Failure to Deliver Shock/Stimulation; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A SUDDEN FACIAL PARALYSIS WHICH BEGINS AFTER THE PATIENT WENT TO THE DENTIST (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS THEN TREATED WITH CORTICOSTEROID (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT ALSO EXPERIENCED A MIDDLE EAR INFECTION (SUPPURATION) AND BIOFILM FORMATION AT THE IMPLANT SITE WHICH WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT ALSO EXPERIENCED A GRADUAL INCREASE IN HEARING PERFORMANCE AND EVENTUALLY ON (B)(6) 2018 (SPECIFIC DATE NOT REPORTED), THE PATIENT SUDDENLY STOPPED RESPONDING TO SOUND. NEURAL RESPONSE TELEMETRY (NRT) WAS ATTEMPTED; HOWEVER, NO MEASUREMENTS WERE OBTAINED. HARDWARE EXCHANGE, TROUBLESHOOTING AND REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT UNDERWENT AN EXPLORATION REVISION SURGERY ON (B)(6) 2019, WHICH REVEALED GRANULATION TISSUE AROUND FACIAL NERVE, INFECTION AT THE MIDDLE EAR AND BIOFILM FORMATION AT THE IMPLANT SITE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED), AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE (SPECIFIC DATE NOT REPORTED).

  Patient problems: Bacterial Infection; Facial Paralysis; Infectious Otitis Media; Medical device site infection; Purulent Discharge

  MAUDE report 25173318 ↗
• InjuryMay 12, 2026Unexpected Therapeutic Results; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC PAIN AT THE IMPLANT SITE (SPECIFIC DATE NOT REPORTED). THE PATIENT EXPERIENCED POOR PERFORMANCE AND SOUND QUALITY WITH THE DEVICE. TROUBLESHOOTING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE NOT REPORTED) FOR 5 DAYS. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Implant Pain

  MAUDE report 25146359 ↗

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.