Cochlear Nucleus ImplantRecalls & reported problems across all models
Cochlear Limited · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13,801
- Deaths reported
- 2
- Injuries reported
- 12,281
- Recalls
- 0
We found 21 models of Cochlear Nucleus Implant by Cochlear Limited in the FDA's device registry (GUDID). Together they are named in 13,801 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2013 and Sep 30, 2026 — classified as 2 deaths, 12,281 injuries, 1,516 malfunctions.
The most frequently reported specific device problem is “Expulsion” (1,579 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 Cochlear Nucleus Implant problems
Device problems
- Appropriate Device Problem Term/Code Not Available6,115
- Expulsion1,579
- Adverse Event Without Identified Device or Use Problem1,037
- Migration722
- No Device Output699
- Positioning Failure592
- Device Dislodged or Dislocated530
- Circuit Failure487
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2,906
- Unspecified Infection1,988
- Hearing Impairment1,366
- Pain1,140
- No Clinical Signs, Symptoms or Conditions1,063
- Tissue Breakdown973
- No Code Available965
- Failure of Implant684
Cochlear Nucleus Implant models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cochlear® Nucleus® CI512 cochlear ImplantIMPLANT, COCHLEAR2,771 reports
- 2,115 reports
- 2,057 reports
- Nucleus Z60353IMPLANT, COCHLEAR2 deaths1,815 reports
- 1,475 reports
- Cochlear® Nucleus® CI612 cochlear ImplantImplant, cochlear1,150 reports
- Nucleus Z190574IMPLANT, COCHLEAR981 reports
- 837 reports
- Nucleus Z60988Hybrid cochlear implant199 reports
- 87 reports
- 72 reports
- Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrodeImplant, cochlear69 reports
- Nucleus Z277598IMPLANT, COCHLEAR36 reports
- Cochlear® Nucleus® Nexa™ cochlear implant CI1012Implant, cochlear35 reports
- Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant Z246604Implant, auditory brainstem33 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 Cochlear Nucleus Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced performance decrement with the device and pain with attempted MRI scan. It was also reported that the patient was getting a second side implanted and wanted both implants to match. Subsequently, the device was explanted on (b)(6) 2026 and the patient was re-implanted with another cochlear device during the same surgery.
Patient problems: Pain
MAUDE report 50943250 ↗InjurySep 30, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced performance decrement with the device and pain with attempted MRI scan. It was also reported that the patient was getting a second side implanted and wanted both implants to match. Subsequently, the device was explanted on (b)(6) 2026 and the patient was re-implanted with another cochlear device during the same surgery.
Patient problems: Pain
MAUDE report 50943249 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50941459 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, a lesion was observed at the surgical scar site. The patient was subsequently hospitalized in (b)(6) 2026 (specific date not reported) due to an infection at the implant site and was treated with antibiotics (specific type, date and duration not reported).
Patient problems: Fistula; Localized Skin Lesion; Medical device site infection
MAUDE report 50934214 ↗InjurySep 29, 2026Positioning Failure; Electrical Shorting
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930550 ↗InjurySep 29, 2026Unexpected Therapeutic Results
Per the clinic, the device was explanted on (b)(6) 2026 due to the poor sound quality. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50928074 ↗InjurySep 29, 2026Unexpected Therapeutic Results
Per the clinic, the device was explanted on (b)(6) 2026 due to the poor sound quality. There are no plans to re-implant 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50928069 ↗InjurySep 29, 2026Signal Artifact/Noise; Therapeutic or Diagnostic Output Failure
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50928053 ↗InjurySep 29, 2026Signal Artifact/Noise; Therapeutic or Diagnostic Output Failure
Per the clinic, the patient reported a sudden onset of screeching sound quality in (b)(6) 2025 while wearing the external processor. The patient was prescribed with prophylactic antibiotics and programming adjustments were made, after which the patient was able to wear the processor intermittently between (b)(6) 2025. In (b)(6) 2026, the patient returned to the clinic reporting recurrence of the screeching sound and stopped wearing the external processor. It was also noted that, the patient experienced performance decrement with the device. Subsequently, the device was explanted on (b)(6) 2026. 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 50928049 ↗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, 2026Failure to Read Input Signal; Intermittent Shock/Stimulation
Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Hardware exchange and 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50927650 ↗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 28, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced zapping, eye swelling, pain due to magnet strength, and headache. The recipient was sedated for an Advanced Telemetry Test due to pain from stimulation. Subsequently, the device was explanted on (b)(6) 2026. The patient was re-implanted with another cochlear device during the same surgery.
Patient problems: Eye Pain; Headache; Pain; Swelling/ Edema
MAUDE report 50910903 ↗
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, combining the brand names used for this product line.
- 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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