Nucleus Z99012Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 09321502003216), received between Mar 5, 2013 and Aug 1, 2025 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “No Device Output” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available; Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO NEED OF MRI SCAN. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

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

  MAUDE report 22684568 ↗
• InjuryFeb 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO NON-USE AND DISCOMFORT AT IMPLANT SITE.

  Patient problems: Discomfort

  MAUDE report 21429117 ↗
• InjuryFeb 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO NON-USE AND DISCOMFORT AT IMPLANT SITE.

  Patient problems: Discomfort

  MAUDE report 21429105 ↗
• MalfunctionJun 22, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT LEADING TO DEVICE NON-USE. THE DEVICE WAS THEN EXPLANTED ON (B)(6) 2022. 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 17179796 ↗
• MalfunctionAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2021, DUE TO PATIENT BEING A NON-USER. THERE ARE NO PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

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

  MAUDE report 15299644 ↗
• InjuryNov 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, PATIENT EXPERIENCED NO BENEFIT WITH THE IMPLANT LEADING TO DEVICE NON-USE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND 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 12876700 ↗
• InjuryNov 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, PATIENT EXPERIENCED NO BENEFIT WITH THE IMPLANT LEADING TO DEVICE NON-USE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND 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 12876679 ↗
• InjuryJul 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DEVICE WAS EXPLANTED ON (B)(6) 2021 (REASON FOR THE EXPLANT UNKNOWN). IT IS UNKNOWN IF THE PATIENT WAS RE-IMPLANTED WITH ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 12208092 ↗
• InjuryJul 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DEVICE WAS EXPLANTED ON (B)(6) 2021 (REASON FOR THE EXPLANT UNKNOWN). IT IS UNKNOWN IF THE PATIENT WAS RE-IMPLANTED WITH ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 12208090 ↗
• InjuryMar 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN, NON-AUDITORY SENSATIONS, PERFORMANCE DECREMENT AND EXTRUSION OF THE ELECTRODE ARRAY INTO THE EXTERNAL AUDITORY CANAL. SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2019. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Hearing Impairment; Pain; Undesired Nerve Stimulation

  MAUDE report 9845641 ↗
• MalfunctionMar 6, 2019No Device Output; No Device Output

  PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE, 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 A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Hearing Impairment

  MAUDE report 8397355 ↗
• InjuryNov 12, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT'S DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO THE REQUIREMENT OF MRI'S. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7023753 ↗
• InjuryJun 21, 2017No Device Output; No Device Output

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. . TROUBLESHOOTING AND EXCHANGE OF THE EXTERNAL COMPONENTS DID NOT RESOLVE THE ISSUE. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: Deafness

  MAUDE report 6656095 ↗
• MalfunctionMar 5, 2013No Device Output; No Device Output

  Patient problems: Failure of Implant; Head Injury; Hematoma

  MAUDE report 2990841 ↗

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.