Nucleus Z60988Recalls & reported problems
Cochlear Limited · Cochlear Nucleus Hybrid L24 cochlear implant · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cochlear Nucleus Hybrid cochlear implant has 196 reports, 193 injuries and no deaths. Many reports describe patients losing residual hearing or speech understanding after activation, and several devices were removed and replaced with another implant. Some describe infection at the implant site. 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
- 199
- Deaths reported
- 0
- Injuries reported
- 196
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 09321502012089), received between Sep 13, 2016 and Sep 21, 2026 — classified as 196 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (18 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, 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 Available129
- Therapeutic or Diagnostic Output Failure18
- Adverse Event Without Identified Device or Use Problem14
- Insufficient Device Problem Information11
- Output Problem9
- Expulsion5
- Migration4
- Device Dislodged or Dislocated3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available63
- Hearing Impairment60
- Unspecified Infection11
- Insufficient Information10
- Head Injury9
- Pain9
- No Clinical Signs, Symptoms or Conditions8
- Patient Problem/Medical Problem7
Recent adverse event reports
The 25 most recent of 199 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryAug 3, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced a performance decrement and tingling sensation with the implanted device. Reprogramming 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50111554 ↗InjuryJun 9, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED A DECLINE IN SPEECH PERFORMANCE AND RESIDUAL HEARING. REPROGRAMMING ATTEMPTS WERE PERFORMED; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT IS NO LONGER A HYBRID USER AND REQUIRES REGULAR MRI EXAMINATIONS. THE DEVICE WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 UNDER GENERAL ANESTHESIA. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25439334 ↗InjuryJun 9, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED A DECLINE IN SPEECH PERFORMANCE AND RESIDUAL HEARING. REPROGRAMMING ATTEMPTS WERE PERFORMED; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT IS NO LONGER A HYBRID USER AND REQUIRES REGULAR MRI EXAMINATIONS. THE DEVICE WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 UNDER GENERAL ANESTHESIA. 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 25439333 ↗InjuryMay 5, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (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 25089670 ↗InjuryMay 5, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (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 25089667 ↗InjuryMar 12, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF ALL LOW-FREQUENCY RESIDUAL ACOUSTIC HEARING. A DECLINE IN THE PATIENT'S SPEECH UNDERSTANDING WAS ALSO NOTED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24578847 ↗InjuryMar 12, 2026Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF ALL LOW-FREQUENCY RESIDUAL ACOUSTIC HEARING. A DECLINE IN THE PATIENT'S SPEECH UNDERSTANDING WAS ALSO NOTED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24578846 ↗InjuryJan 15, 2026Expulsion
PER THE CLINIC, AN INFECTION HAD DEVELOPED AT THE IMPLANT SITE, EXPOSING THE RECEIVER/STIMULATOR. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.
Patient problems: Medical device site infection
MAUDE report 24090216 ↗InjuryDec 4, 2025Unexpected Therapeutic Results; Therapeutic or Diagnostic Output Failure; Noise, Audible; Unexpected Therapeutic Results; Therapeutic or Diagnostic Output Failure; Noise, Audible
PER THE CLINIC, THE PATIENT EXPERIENCED POOR SOUND QUALITY, POOR DEVICE PERFORMANCE SINCE ACTIVATION AND PROGRESSIVE LOSS OF RESIDUAL LOW FREQUENCY HEARING. THE SOUND QUALITY WAS ALSO DESCRIBED AS TOO HIGH PITCHED AND SCREECHY. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025, 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 23715233 ↗InjuryDec 4, 2025Unexpected Therapeutic Results; Therapeutic or Diagnostic Output Failure; Noise, Audible; Unexpected Therapeutic Results; Therapeutic or Diagnostic Output Failure; Noise, Audible
CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON DECEMBER 04, 2025, WAS FILED INADVERTENTLY. THE CORRECT DATE OF AWARENESS IS OCTOBER 30, 2025; NOT NOVEMBER 07, 2025 AS PREVIOUSLY REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23715219 ↗InjuryNov 20, 2025Circuit Failure; Impedance Problem; Therapeutic or Diagnostic Output Failure; Circuit Failure; Impedance Problem; Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN, FACIAL TWITCHING AND PERFORMANCE DECREMENT WITH THE DEVICE USE. FLUCTUATING IMPEDANCES WERE OBSERVED ACROSS THE ELECTRODE ARRAY AND OPEN CIRCUIT WAS NOTED ON 1 ELECTRODE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Pain; Undesired Nerve Stimulation
MAUDE report 23601657 ↗InjuryNov 20, 2025Circuit Failure; Impedance Problem; Therapeutic or Diagnostic Output Failure; Circuit Failure; Impedance Problem; Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN, FACIAL TWITCHING AND PERFORMANCE DECREMENT WITH THE DEVICE USE. FLUCTUATING IMPEDANCES WERE OBSERVED ACROSS THE ELECTRODE ARRAY AND OPEN CIRCUIT WAS NOTED ON 1 ELECTRODE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025, AND THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Pain; Undesired Nerve Stimulation
MAUDE report 23601655 ↗InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO UNKNOWN REASON. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23037532 ↗InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO UNKNOWN REASON. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23037528 ↗InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED LACK OF BENEFIT WITH THE INTERNAL DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025, 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 22920422 ↗InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED LACK OF BENEFIT WITH THE INTERNAL DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025, AND THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22920421 ↗InjuryMay 13, 2025Output Problem; Output Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, 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 22007663 ↗InjuryMay 13, 2025Output Problem; Output Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, AND THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22007660 ↗InjuryMar 14, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025. 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 21603087 ↗InjuryMar 14, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025. 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 21603086 ↗InjuryMar 12, 2025Failure to Deliver Shock/Stimulation; Appropriate Device Problem Term/Code Not Available; Failure to Deliver Shock/Stimulation; Appropriate Device Problem Term/Code Not Available
BASED ON CLINICAL SYMPTOMS AND TROUBLESHOOTING PERFORMED (DATE NOT REPORTED) IT WAS DETERMINED THAT THE RESULTS ARE CONSISTENT WITH A DEVICE MALFUNCTION.
Patient problems: Head Injury
MAUDE report 21590657 ↗InjuryMar 12, 2025Failure to Deliver Shock/Stimulation; Appropriate Device Problem Term/Code Not Available; Failure to Deliver Shock/Stimulation; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT SUSTAINED A HEAD TRAUMA DUE TO AN ACCIDENT (SPECIFIC DATE NOT REPORTED) LEADING TO A LOSS OF IMPLANT FUNCTION. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE WITHIN THE SAME SURGERY.
Patient problems: Head Injury
MAUDE report 21590637 ↗InjuryJan 3, 2025Output Problem; Output Problem
PER THE CLINIC, THE PATIENT EXPERIENCED TINNITUS AND POOR PERFORMANCE FROM THE DEVICE USE. SUBSEQUENTLY, THE PATIENT OPTED TO ONLY USING A HEARING AID SYSTEM AND THE IMPLANTED DEVICE REMAIN DORMANT; HOWEVER, THE PATIENT CONTINUE TO HAVE DECLINE IN PERFORMANCE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2024, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Tinnitus
MAUDE report 21064554 ↗
Other Hybrid cochlear implant devices
- Mi1250 SYNCHRONY 2 FLEX24 S-Vector Magnet 39543Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification23 reports
- Mi1250 SYNCHRONY 2 FLEX24 36680Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification17 reports
- Mi1200 SYNCHRONY +FLEX20 07880Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification8 reports
- Mi1210 SYNCHRONY ST +FLEX24 33186Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification7 reports
- Mi1250 SYNCHRONY 2 PIN FLEX24 S-Vector Magnet 39542Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification6 reports
- Mi1250 SYNCHRONY 2 FLEX20 37175Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification4 reports
- Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet 41544Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3 reports
- Mi1250 SYNCHRONY 2 PIN FLEX20 S-Vector Magnet 39548Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification2 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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