Cochlear® Nucleus® CI612 cochlear ImplantRecalls & reported problems
Cochlear Limited · with Contour Advance® electrode · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cochlear Nucleus CI612 cochlear implant is surgically placed to help people hear. Of its 1,140 reports, 1,078 describe injuries and 62 describe malfunctions, with no deaths. The reports describe electrodes shifting or being pushed out, poor sound from interference between internal parts, short circuits, and infections, and recent reports often describe the implant being removed. Reports fell to 129 in the last 12 months from 248 in the previous 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,150
- Deaths reported
- 0
- Injuries reported
- 1,087
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,150 adverse event reports that list this exact device (DI 09321502036818), received between Oct 21, 2019 and Sep 29, 2026 — classified as 1,087 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Expulsion” (132 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available491
- Expulsion132
- Positioning Failure108
- Adverse Event Without Identified Device or Use Problem96
- Migration68
- Insufficient Device Problem Information60
- Therapeutic or Diagnostic Output Failure58
- Circuit Failure45
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available353
- Unspecified Infection196
- No Clinical Signs, Symptoms or Conditions118
- Tissue Breakdown112
- Pain74
- Insufficient Information70
- Swelling/ Edema39
- Bacterial Infection38
Recent adverse event reports
The 25 most recent of 1,150 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Positioning Failure; Electrical Shorting
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930550 ↗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 ↗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 (date unspecified). 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 reimplanted with another cochlear device during the same surgery.
Patient problems: Eye Pain; Headache; Pain; Swelling/ Edema
MAUDE report 50910890 ↗InjurySep 24, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (b)(6) 2026 due to an unspecified reason. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Insufficient Information
MAUDE report 50878067 ↗InjurySep 24, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (b)(6) 2026 due to an unspecified reason. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Insufficient Information
MAUDE report 50878065 ↗InjurySep 23, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (b)(6) 2026 due to an unknown reason. The patient was reimplanted with another cochlear device during the same surgery. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Insufficient Information
MAUDE report 50864912 ↗InjurySep 23, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (b)(6) 2026 due to an unknown reason. The patient was re-implanted with another cochlear device during the same surgery. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Insufficient Information
MAUDE report 50864911 ↗InjurySep 17, 2026Expulsion
Per the clinic, the device was explanted on (b)(6) 2026, due to an extrusion of the receiver/stimulator. The patient was re-implanted with another cochlear device during the same surgery.
Patient problems: Tissue Breakdown
MAUDE report 50799066 ↗InjurySep 15, 2026Failure to Deliver Shock/Stimulation; Failure to Read Input Signal
Per the clinic, the patient experienced non-functioning device and loss of connection to the internal device subsequent to sustaining a head trauma on (b)(6) 2026. Hardware exchange attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.
Patient problems: Head Injury
MAUDE report 50774631 ↗InjurySep 10, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (b)(6) 2026 due to an unknown reason. The patient was reimplanted with another device during the same surgery.
Patient problems: Insufficient Information
MAUDE report 50706939 ↗InjurySep 10, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted on (b)(6) 2026 due to an unknown reason. The patient was re-implanted with another device during the same surgery.
Patient problems: Insufficient Information
MAUDE report 50706936 ↗InjurySep 8, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50679866 ↗InjurySep 8, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50679641 ↗MalfunctionSep 3, 2026Circuit Failure; Failure to Deliver Shock/Stimulation
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50589442 ↗InjurySep 2, 2026Expulsion
Patient problems: Medical device site infection
MAUDE report 50557075 ↗InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced a wound-healing disorder and infection (site of infection not confirmed). It was also reported that the implant was significantly overgrown/adhered to the surrounding tissue, and the sound processor could not be comfortably carried/worn. Subsequently, the device was electively explanted on (b)(6) 2026, and 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: Impaired Healing; Unspecified Infection
MAUDE report 50024836 ↗InjuryJul 27, 2026Signal Artifact/Noise; Unexpected Therapeutic Results; Positioning Problem
Per the clinic, the patient experienced poor performance with the device due to the internal receiver stimulators being in close proximity to one another, resulting in interference and poor sound quality. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted (b)(6) 2026, 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 50011806 ↗InjuryJul 27, 2026Signal Artifact/Noise; Unexpected Therapeutic Results; Positioning Problem
Per the clinic, the patient experienced poor performance with the device due to the internal receiver stimulators being in close proximity to one another, resulting in interference and poor sound quality. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted (b)(6)2026, 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 50011799 ↗InjuryJul 27, 2026Electrical Shorting
Per the clinic the device was explanted on (b)(6)2026, due to short circuits. The patient was reimplanted with another cochlear device during the same surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003787 ↗InjuryJul 27, 2026Electrical Shorting
Per the clinic the device was explanted on (b)(6) 2026, due to short circuits. The patient was reimplanted with another cochlear device during the same surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003784 ↗InjuryJun 29, 2026Insufficient Device Problem Information
PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) FOR UNKNOWN REASONS. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2026. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25648744 ↗InjuryJun 24, 2026Insufficient Device Problem Information
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO UNKNOWN REASON AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25603810 ↗InjuryJun 24, 2026Insufficient Device Problem Information
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO UNKNOWN REASON AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25603809 ↗InjuryJun 22, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED), DUE TO AN INFECTION (SITE OF INFECTION NOT CONFIRMED). 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: Unspecified Infection
MAUDE report 25588866 ↗InjuryJun 19, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT DEVELOPED MASTOIDITIS AND BACTERIAL INFECTION (SPECIFIC DATE NOT REPORTED); SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). THE DEVICE WAS EXPLANTED ON (B)(6) 2026 AND WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY IN THE CONTRALATERAL EAR.
Patient problems: Bacterial Infection; Mastoiditis
MAUDE report 25556549 ↗
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 · TerminatedCochlear 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 · TerminatedCochlear 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 · TerminatedNucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Other Implant, cochlear devices
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Advanced Bionics AG · Implant, Cochlear2,918 reports
- Cochlear® Nucleus® CI512 cochlear ImplantCochlear Limited · IMPLANT, COCHLEAR2,771 reports
- Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCochlear Limited · Implant, cochlear2,115 reports
- Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCochlear Limited · Implant, cochlear2,057 reports
- Nucleus Z60353Cochlear Limited · IMPLANT, COCHLEAR2 deaths1,815 reports
- Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCochlear Limited · IMPLANT, COCHLEAR1,475 reports
- Nucleus Z190574Cochlear Limited · IMPLANT, COCHLEAR981 reports
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04Advanced Bionics AG · Implant, Cochlear1 death931 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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