Nucleus Z285983Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09321502023436), received between Nov 19, 2017 and Jun 24, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Melted” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2021Melted; Melted

  IT WAS REPORTED THAT THE RECHARGEABLE BATTERY HAD MELTED. THE RECHARGEABLE BATTERY HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. REPLACEMENT EQUIPMENT WAS SENT, AND NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055830 ↗
• InjuryJun 24, 2021Melted; Melted

  IT WAS REPORTED THAT THE RECHARGEABLE BATTERY HAD MELTED. THE RECHARGEABLE BATTERY HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. REPLACEMENT EQUIPMENT WAS SENT, AND NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055817 ↗
• MalfunctionNov 19, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE RECHARGEABLE BATTERY WAS ALLEGEDLY LEAKING FLUID. REPLACEMENT EQUIPMENT WAS ISSUED, AND NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044247 ↗

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.