NucleusRecalls & reported problems across all models
Cochlear Limited · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,100
- Deaths reported
- 2
- Injuries reported
- 2,817
- Recalls
- 0
We found 10 models of Nucleus by Cochlear Limited in the FDA's device registry (GUDID). Together they are named in 3,100 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2013 and Sep 29, 2026 — classified as 2 deaths, 2,817 injuries, 280 malfunctions.
The most frequently reported specific device problem is “Expulsion” (360 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Nucleus problems
Device problems
- Appropriate Device Problem Term/Code Not Available1,611
- Expulsion360
- Adverse Event Without Identified Device or Use Problem289
- Migration124
- Insufficient Device Problem Information114
- Extrusion103
- Device Dislodged or Dislocated98
- No Device Output78
Patient problems
- Unspecified Infection472
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available433
- Hearing Impairment401
- No Code Available321
- Pain292
- Tissue Breakdown193
- Patient Problem/Medical Problem183
- No Clinical Signs, Symptoms or Conditions181
Nucleus models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nucleus Z60353IMPLANT, COCHLEAR2 deaths1,815 reports
- Nucleus Z190574IMPLANT, COCHLEAR981 reports
- Nucleus Z60988Hybrid cochlear implant199 reports
- Nucleus Z277598IMPLANT, COCHLEAR36 reports
- Nucleus Z43006IMPLANT, COCHLEAR27 reports
- Nucleus Z43007IMPLANT, COCHLEAR15 reports
- Nucleus Z99012IMPLANT, COCHLEAR14 reports
- Nucleus Z43004IMPLANT, COCHLEAR9 reports
- Nucleus Z285983IMPLANT, COCHLEAR3 reports
- Nucleus Z285969IMPLANT, COCHLEAR1 report
Recent Nucleus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Implant Pain
MAUDE report 50927680 ↗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 28, 2026Migration
Per the clinic, the patient experienced pain in the pinna due to implanted device migration. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Pain
MAUDE report 50910920 ↗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, 2026Device Dislodged or Dislocated
Per the clinic, the patient experienced a magnet dislodgement from an unknown cause (specific date not reported) and the patient underwent a surgical procedure on (b)(6) 2026. During the surgery, it was observed that the silicone had torn and the magnet was displaced leading to the decision to explant the device. The patient was re-implanted with a new device during the same surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836317 ↗InjurySep 21, 2026Device Dislodged or Dislocated
Per the clinic, the patient experienced a magnet dislodgement from an unknown cause (specific date not reported) and the patient underwent a surgical procedure on (b)(6) 2026. During the surgery, it was observed that the silicone had torn and the magnet was displaced leading to the decision to explant the device. The patient was re-implanted with a new device during the same surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836309 ↗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, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (specific date not reported) for unknown reasons.It is unknown if there are plans to reimplant the patient 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: Insufficient Information
MAUDE report 50835365 ↗InjurySep 21, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (specific date not reported) for unknown reasons.It is unknown if there are plans to reimplant the patient 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: Insufficient Information
MAUDE report 50835361 ↗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 21, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced a performance decrement resulting in the decision to discontinue use of the device. The implanted device remains. The device was explanted (b)(6) 2026. The patient was reimplanted with a new device (specific date not reported).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50835151 ↗InjurySep 21, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced a performance decrement resulting in the decision to discontinue use of the device. The implanted device remains. The device was explanted (b)(6) 2026. The patient was re-implanted with a new device (specific date not reported).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50835150 ↗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 ↗
Other Cochlear Limited products
All Cochlear Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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