Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrodeRecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 09321502046329), received between Oct 19, 2020 and Sep 24, 2026 — classified as 68 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced pain/non auditory sensations 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: Pain

  MAUDE report 50878481 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced pain/non auditory sensations 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: Pain

  MAUDE report 50878480 ↗
• InjuryApr 20, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND UNDERWENT REVISION SURGERY ON (B)(6) 2025 (SPECIFIC DATE NOT REPORTED); IN ORDER TO DRAIN SEROMA AT INCISION SITE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24926643 ↗
• InjuryMar 18, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. DURING FOLLOW-UP EXAMINATION, THE PATIENT UNDERWENT A CT SCAN WHICH REVEALED 5-6 ELECTRODES PLACED EXTRA-COCHLEARLY WHICH LED TO THE DECISION TO EXPLANT THE DEVICE. 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: Extraskeletal ossification; Scar Tissue

  MAUDE report 24635714 ↗
• InjuryMar 18, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. DURING FOLLOW-UP EXAMINATION, THE PATIENT UNDERWENT A CT SCAN WHICH REVEALED 5-6 ELECTRODES PLACED EXTRA-COCHLEARLY WHICH LED TO THE DECISION TO EXPLANT THE DEVICE. 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: Extraskeletal ossification

  MAUDE report 24635713 ↗
• InjuryFeb 4, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND SWELLING AT THE MAGNET SITE, LEADING TO NON-USE OF THE SOUND PROCESSOR IN (B)(6) 2025 (SPECIFIC DATES NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY IN (B)(6) 2025 (SPECIFIC DATE NOT REPORTED), TO DRAIN A SEROMA AT THE INCISION SITE. THE PATIENT WAS ALSO TREATED WITH MULTIPLE ROUNDS OF ANTIBIOTICS (SPECIFIC DATES, DURATION AND TYPES NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Pain; Seroma; Swelling/ Edema

  MAUDE report 24255703 ↗
• InjuryNov 4, 2025Expulsion; Expulsion

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION, EXPERIENCED SKIN BREAKDOWN AT IMPLANT SITE AND EXTRUSION OF THE ELECTRODE ARRAY. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH MULTIPLE ROUNDS OF ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED); HOWEVER, THE ISSUE DID NOT RESOLVE. THE DEVICE WAS EXPLANTED ON (B)(6) 2025. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 23472994 ↗
• InjuryNov 4, 2025Expulsion; Expulsion

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION, EXPERIENCED SKIN BREAKDOWN AT IMPLANT SITE AND EXTRUSION OF THE ELECTRODE ARRAY. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH MULTIPLE ROUNDS OF ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED); HOWEVER, THE ISSUE DID NOT RESOLVE. THE DEVICE WAS EXPLANTED ON (B)(6) 2025. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Medical device site infection; Tissue Breakdown

  MAUDE report 23472992 ↗
• InjurySep 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING, POOR WOUND HEALING, DEVELOPED A WOUND DEHISCENCE AND INFECTION AT THE INCISION SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR A DURATION OF 10 DAYS (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing; Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23012604 ↗
• InjurySep 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING, POOR WOUND HEALING, DEVELOPED A WOUND DEHISCENCE AND INFECTION AT THE INCISION SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR A DURATION OF 10 DAYS (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing; Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23012602 ↗
• InjuryJun 24, 2025Expulsion; Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE ELECTRODE INTO THE EAR CANAL. IT WAS ALSO REPORTED THAT THERE WAS CHRONIC TYMPANIC MEMBRANE PERFORATION WITH INTERMITTENT OTORRHEA AND BREAKDOWN OF CANAL CLOSURE. THE DEVICE WAS EXPLANTED ON (B)(6) 2025 AND RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Fluid Discharge; Perforation; Tissue Breakdown

  MAUDE report 22313049 ↗
• InjuryJun 24, 2025Expulsion; Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE ELECTRODE INTO THE EAR CANAL. IT WAS ALSO REPORTED THAT THERE WAS CHRONIC TYMPANIC MEMBRANE PERFORATION WITH INTERMITTENT OTORRHEA AND BREAKDOWN OF CANAL CLOSURE. THE DEVICE WAS EXPLANTED ON (B)(6) 2025 AND RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Fluid Discharge; Perforation; Tissue Breakdown

  MAUDE report 22313047 ↗
• InjuryFeb 9, 2025Circuit Failure; Circuit Failure

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 AND THE PATIENT WAS REIMPLANTED WITH A NEW COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341316 ↗
• InjuryFeb 9, 2025Circuit Failure; Circuit Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED OPEN CIRCUITS WITH THE ELECTRODES (SPECIFIC DATE NOT REPORTED). THERE ARE PLANS TO EXPLANT THE DEVICE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341312 ↗
• InjuryNov 12, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  PER THE CLINIC, THE PATIENT EXPERIENCED LOSS OF CONNECTION TO THE INTERNAL DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED), AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20670255 ↗
• InjuryNov 12, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  PER THE CLINIC, THE PATIENT EXPERIENCED LOSS OF CONNECTION TO THE INTERNAL DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED), AND IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20670230 ↗
• InjurySep 18, 2024Positioning Failure; Positioning Failure

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 DUE TO IMPROPER PLACEMENT OF THE ELECTRODE ARRAY AND POOR PERFORMANCE WITH THE DEVICE. 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 20243339 ↗
• InjurySep 18, 2024Positioning Failure; Positioning Failure

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 DUE TO IMPROPER PLACEMENT OF THE ELECTRODE ARRAY AND POOR PERFORMANCE WITH THE DEVICE. 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 20243337 ↗
• MalfunctionApr 24, 2024Migration; Migration

  PER THE CLINIC, THE PATIENT EXPERIENCED A MIGRATION OF THE ELECTRODE ARRAY AND TINGLING SENSATION WITH STIMULATION SUBSEQUENT TO SUSTAINING A HEAD INJURY. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 UNDER GENERAL ANESTHESIA AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Head Injury

  MAUDE report 19170201 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 IN ORDER TO PERFORM MRI PROCEDURE. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19150757 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 IN ORDER TO PERFORM MRI PROCEDURE. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19150749 ↗
• InjuryApr 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL ANTIBIOTICS, HOWEVER, THE ISSUE DID NOT RESOLVE. THE DEVICE WAS EXPLANTED ON (B)(6) 2024. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19048499 ↗
• InjuryApr 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL ANTIBIOTICS, HOWEVER, THE ISSUE DID NOT RESOLVE. THE DEVICE WAS EXPLANTED ON (B)(6) 2024. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19048494 ↗
• InjuryJan 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT WAS HOSPITALIZED IN (B)(6) 2023 (SPECIFIC DATE NOT REPORTED) FOR VERTIGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY (SPECIFIC DATE NOT REPORTED) FOR UNSPECIFIED REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Vertigo

  MAUDE report 18509981 ↗
• InjuryJan 11, 2024Migration; Migration

  PER THE CLINIC, THE PATIENT EXPERIENCED A MIGRATION OF ELECTRODE ARRAY. THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022 IN ORDER TO REINSERT THE ELECTRODE ARRAY. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18490480 ↗

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.