Nucleus Z43007Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 09321502002349), received between Feb 8, 2017 and Jan 22, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Expulsion” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT REFUSED TO USE THE DEVICE, LEADING TO NON-USE AND NO BENEFIT. WITH THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2024. 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 21214261 ↗
• MalfunctionSep 22, 2024Adverse 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) 2024, DUE TO NON-USE FOR MORE THAN 15 YEARS. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276307 ↗
• InjurySep 22, 2024Adverse 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) 2024, DUE TO NON-USE FOR MORE THAN 15 YEARS. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276306 ↗
• InjurySep 27, 2021Expulsion; Expulsion

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021 DUE TO EXTRUSION OF THE ELECTRODE LEAD INTO THE EXTERNAL AUDITORY CANAL. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531373 ↗
• InjurySep 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN FLAP INFECTION AROUND THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED WITH ORAL ANTIBIOTICS FOR A TOTAL OF 70 DAYS BETWEEN (B)(6) 2019, AND (B)(6) 2021, HOWEVER, THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY, THE PATIENT EXPERIENCED SWELLING AT MAGNET SITE RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2021. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Skin Infection; Swelling/ Edema

  MAUDE report 12531372 ↗
• InjuryAug 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021, DUE TO EXTRUSION OF THE ELECTRODE OUT INTO THE EXTERNAL AUDITORY CANAL. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

  Patient problems: Pain

  MAUDE report 12381639 ↗
• InjuryJul 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE RESULTING IN BREAKDOWN OF THE SKIN FLAP AND EXPOSURE OF THE RECEIVER-STIMULATOR. IT IS UNKNOWN WHAT TREATMENT THE PATIENT HAS RECEIVED FOR THE REPORTED INFECTION.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10348347 ↗
• InjuryJul 23, 2020Expulsion; Expulsion

  PER THE SURGEON, THERE ARE PLANS TO EXPLANT DUE TO AN EXTRUSION OF THE ELECTRODE LEAD INTO THE EXTERNAL AUDITORY CANAL (DATE NOT REPORTED). THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10312463 ↗
• InjuryJul 1, 2020Output Problem; Output Problem

  PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT DEVELOPED MENINGITIS IN 2020 (SPECIFIC DATE NOT REPORTED) WHICH WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS (TYPE AND DURATION NOT REPORTED) AND WAS HEALED IN (B)(6) 2020. FOLLOWING THE EPISODE OF MENINGITIS, THE PATIENT BEGAN TO EXPERIENCE PAIN AROUND THE IMPLANT SITE AND A PERFORMANCE DECREMENT WITH DEVICE USE. IT IS UNKNOWN WHETHER THERE ARE PLANS TO EXPLANT THE DEVICE, AS OF THE DATE OF THIS REPORT. THE PATIENT CONTINUES TO BE CLINICALLY MONITORED BY THEIR HEALTHCARE PROVIDER.

  Patient problems: Meningitis

  MAUDE report 10222377 ↗
• InjuryJun 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PER THE CLINIC, IT WAS REPORTED THE DEVICE WAS EXPLANTED DUE TO AN UNREPORTED REASON ON AN UNKNOWN DATE.

  Patient problems: No Information

  MAUDE report 10216191 ↗
• InjuryOct 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO NON-DEVICE RELATED MEDICAL ISSUES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9264605 ↗
• InjurySep 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  PER THE CLINIC, THE PATIENT EXPERIENCED A MIGRATION OF THE ELECTRODE ARRAY AND SUBSEQUENT EXTRUSION OF THE ARRAY INTO THE AUDITORY CANAL. REVISION SURGERY IS SCHEDULED; HOWEVER, HAS YET TO OCCUR AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8953053 ↗
• InjuryJun 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2018 DUE TO OTITIS MEDIA WITH CHOLESTEATOMA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7599800 ↗
• InjuryJun 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2017, DUE TO THE PATIENT EXPERIENCING PAIN WITH DEVICE USE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

  Patient problems: Pain

  MAUDE report 6613701 ↗
• MalfunctionFeb 8, 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, FEBRUARY 09, 2017.

  Patient problems: Hearing Impairment

  MAUDE report 6313040 ↗

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.