Nucleus Z43006Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 09321502002332), received between Sep 20, 2016 and Nov 20, 2025 — classified as 21 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Expulsion” (4 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED POST-AURAL DISCHARGE IN (B)(6) 2021 (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS LATER HOSPITALIZED (SPECIFIC DATE AND DURATION NOT REPORTED) AND WAS TREATED WITH ORAL AND INTRAVENOUS ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Fluid Discharge

  MAUDE report 23613415 ↗
• InjuryNov 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A RECURRENT POST-AURICULAR DISCHARGE. THE PATIENT WAS HOSPITALIZED AND MANAGED CONSERVATIVELY WITH INTRAVENOUS AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED); HOWEVER, THE CONDITION DID NOT RESOLVE. SUBSEQUENTLY, THE PATIENT WAS UNDERGOES A REVISION SURGERY ON (B)(6) 2025. DURING SURGERY, THE SURGEON FOUND AN INFECTION SURROUNDING THE ENTIRE IMPLANT, WITH BIOFILM AND A PSEUDOCAPSULE FORMATION. BASED ON THESE INTRAOPERATIVE FINDINGS, THE DECISION WAS MADE TO EXPLANT THE DEVICE TO ELIMINATE THE SOURCE OF INFECTION. THERE ARE NO 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: Bacterial Infection

  MAUDE report 23613138 ↗
• InjuryOct 17, 2025Expulsion; Expulsion

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE, EXPOSING THE RECEIVER/STIMULATOR. THE DEVICE WAS INFECTED AND COVERED WITH GRANULATION AND HAD BACTERIAL BIOFILMS. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL, TOPICAL AND IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER, THIS DID NOT ALLEVIATE THE PROBLEM RESULTING IN A DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2025. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

  Patient problems: Medical device site infection; Tissue Breakdown

  MAUDE report 23320636 ↗
• InjuryAug 1, 2025Output Problem; Output Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO NEED FOR AN MRI SCAN. IT IS UNKNOWN IF THERE ARE 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 22687285 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO DEVICE NON-USE AND NEED FOR FREQUENT MRIS (FOR NON-DEVICE RELATED 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 22539370 ↗
• MalfunctionApr 4, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE AND PAIN WITH THE DEVICE. TROUBLESHOOTING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2024, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Pain

  MAUDE report 19039456 ↗
• InjuryNov 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2023, DUE TO ELECTRODE OUT OF COCHLEA AND AN INFECTION (NON-DEVICE RELATED). 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 18203020 ↗
• InjuryJun 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2023, DUE TO AN INFECTION (NON-DEVICE RELATED).

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

  MAUDE report 17132262 ↗
• InjuryFeb 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6), 2023 DUE TO AN INFECTION (NON-DEVICE RELATED). 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 16402617 ↗
• InjuryOct 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE DUE TO MIGRATION OF THE ELECTRODE LEAD INTO THE EXTERNAL AUDITORY CANAL. THE DEVICE WAS EXPLANTED ON (B)(6) 2022, 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 15637057 ↗
• MalfunctionMar 30, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF CONNECTION TO THE INTERNAL DEVICE. 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.

  Patient problems: Failure of Implant

  MAUDE report 13947522 ↗
• InjuryDec 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR MAGNET RETENTION AND WAS SUBSEQUENTLY HOSPITALIZED (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021 FOR A SKIN REVISION SURGERY. SUBSEQUENTLY THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND SWELLING. THE WOUND HAS REPORTED TO HAVE IMPROVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Skin Infection; Swelling/ Edema

  MAUDE report 12914839 ↗
• InjuryNov 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PER THE CLINIC, THE PATIENT EXPERIENCED MIDDLE EAR INFECTION CAUSING PERFORATION OF THE EARDRUM WHICH LED TO THE EXTRUSION OF THE ELECTRODES. THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2021. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Perforation

  MAUDE report 12859116 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE SURGEON, THE PATIENT EXPERIENCED RECURRENT INFECTIONS WHICH RESULTED IN THREE SKIN FLAP ROTATION SURGERIES. THERE HAS BEEN ANOTHER INFECTION WHEREBY THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 10463976 ↗
• InjuryJul 21, 2020Expulsion; Expulsion

  PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXTRUSION OF THE ELECTRODE ARRAY THROUGH THE TYMPANIC MEMBRANE SUBSEQUENT TO A NON-DEVICE RELATED INFECTION. IT IS UNKNOWN WHETHER THERE ARE PLANS TO EXPLANT THE DEVICE, AS OF THE DATE OF THIS REPORT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10306056 ↗
• InjuryMar 21, 2019Expulsion; Expulsion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BREAKDOWN OF WOUND AND EXTRUSION OF THE DEVICE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ANTIBIOTICS (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Patient Problem/Medical Problem; Tissue Breakdown; Unspecified Infection

  MAUDE report 8439072 ↗
• InjuryFeb 5, 2019Migration; Migration

  PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO EXTRUSION OF THE ELECTRODE LEAD INTO THE EXTERNAL AUDITORY CANAL. THE PATIENT WAS CONTRALATERALLY REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

  Patient problems: No Code Available

  MAUDE report 8308720 ↗
• MalfunctionFeb 3, 2019No Device Output; No Device Output

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE; HOWEVER THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Hearing Impairment

  MAUDE report 8300617 ↗
• InjuryJan 6, 2019Impedance Problem; Impedance Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND AN INFECTION AT THE IMPLANT SITE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2018. THE PATIENT WAS NOT REIMPLANTED WITH ANOTHER DEVICE.

  Patient problems: Hearing Impairment; Unspecified Infection

  MAUDE report 8220664 ↗
• InjuryJul 5, 2018Expulsion; Extrusion; Expulsion; Extrusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2018 DUE EXTRUSION OF THE ELECTRODE INTO THE EAR CANAL. THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 7662910 ↗
• InjuryOct 25, 2017Extrusion; Extrusion

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2017, DUE TO AN EXTRUSION OF THE ELECTRODE ARRAY INTO THE AUDITORY CANAL. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6978698 ↗
• MalfunctionMay 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO A SURGICAL PROBLEM ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, MAY 23, 2017.

  Patient problems: No Code Available

  MAUDE report 6583779 ↗
• InjuryMay 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE, SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2017. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

  Patient problems: Hearing Impairment

  MAUDE report 6559492 ↗
• InjuryMar 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN FLAP BREAKDOWN AND AN INFECTION AT IMPLANT SITE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE PATIENT'S WOUND WAS STERILIZED AND DRESSED AND THE PATIENT WAS PRESCRIBED WITH ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). HOWEVER THE ISSUE COULD NOT BE RESOLVED RESULTING IN THE DECISION TO EXPLANT THE DEVICE ON (B)(6) 2017. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON THE CONTRALATERAL SIDE.

  Patient problems: Bacterial Infection

  MAUDE report 6419816 ↗
• MalfunctionFeb 28, 2017No 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, MARCH 01, 2017.

  Patient problems: Hearing Impairment

  MAUDE report 6367211 ↗

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.