Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,475 adverse event reports that list this exact device (DI 09321502032599), received between Sep 4, 2016 and Sep 30, 2026 — classified as 1,290 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (172 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 1,475 reports, 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, 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 25, 2026Device Dislodged or Dislocated

  Per the clinic, the patient experienced magnet dislodgement during an MRI of the lumbar spine. 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 50893452 ↗
• MalfunctionSep 21, 2026Circuit Failure; Failure to Deliver Shock/Stimulation

  Per the clinic, the patient experienced no sound with the device use. Upon further evaluation, open circuits were noted on all 22 electrodes. Troubleshooting attempts were made; however, the issue could not be resolved. The implanted device remains. It is unknown if there are plans to explant the device and reimplant the patient with another cochlear device as of the date of this report.

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

  MAUDE report 50837315 ↗
• InjurySep 17, 2026Failure to Read Input Signal

  Per the clinic, the patient underwent an MRI in 2024 (specific date not reported). Following the MRI, the patient experienced pain while wearing the sound processor, and no connection could be established with the implant. A revision surgery was subsequently performed (specific date not reported) to replace the magnet; however, connection with the implant could still not be established following the procedure. 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: Pain

  MAUDE report 50800696 ↗
• InjurySep 15, 2026Device Dislodged or Dislocated; Device Handling Problem

  Per the clinic, the patient experienced pain during a 3 Tesla MRI procedure. The patient's head had been wrapped in accordance with Cochlear's recommendations; however, the implant magnet subsequently became dislodged during the MRI, resulting in damage to the implant magnet pocket. It was reported that the MRI kit was applied incorrectly. Surgery to replace the magnet was subsequently completed (date not reported).

  Patient problems: Pain

  MAUDE report 50769061 ↗
• InjurySep 15, 2026Biofilm coating in Device

  Per the clinic, the patient experienced slight swelling at the implant site, accompanied by serous discharge and granulation tissue at the wound site. Subsequently, the patient was treated with IV antibiotics for 10 days (date not reported), however, slight serous discharge persisted. Upon examination (date not reported), a biofilm formation was observed. There are plans to clean the wound via surgery; however, this has not occurred as of the date of this report.

  Patient problems: Fluid Discharge; Medical device site infection; Swelling/ Edema

  MAUDE report 50768533 ↗
• MalfunctionSep 9, 2026Circuit Failure; Failure to Deliver Shock/Stimulation; Output Problem

  Per the clinic, open circuits were noted on 14 electrodes and the patient reportedly was no longer hearing from the implanted device. There are plans to explant the device; however, this has not occurred as of the date of this report.

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

  MAUDE report 50685494 ↗
• InjurySep 8, 2026Failure to Read Input Signal; Device Dislodged or Dislocated; Patient Device Interaction Problem

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50680139 ↗
• InjuryAug 23, 2026Device Dislodged or Dislocated

  Per the clinic, the patient experienced pain and magnet dislodgement during an MRI on (b)(6) 2026. Following the MRI, the magnet site was noted to be red. The patient's head was wrapped as recommended by Cochlear. The magnet was placed back into correct position without surgical intervention, and the patient was initially able to wear the device with lower magnet retention. However, the issue could not be resolved. The device was subsequently explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Erythema; Pain

  MAUDE report 50397126 ↗
• InjuryJul 29, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient sustained trauma to the implant site, resulting in skin breakdown that failed to heal. The patient was initially scheduled for a flap procedure; however, upon opening the site, the surgeon identified an infection at the implant site and cholesteatoma, resulting in the decision to explant the device. The device was explanted on (b)(6) 2026. There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

  Patient problems: Head Injury; Impaired Healing; Medical device site infection; Tissue Breakdown

  MAUDE report 50066523 ↗
• InjuryJul 28, 2026Positioning Failure

  Per the clinic, the device was explanted on (b)(6) 2026 due to improper placement resulting from abnormal anatomy.

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

  MAUDE report 50049615 ↗
• InjuryJun 23, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A SUSPECTED DEVICE FAILURE AFTER MRI PROCEDURE ON (B)(6) 2021. 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 25603352 ↗
• MalfunctionJun 9, 2026No Device Output

  PER THE CLINIC, THE PATIENT EXPERIENCE NO SOUND WITH THE IMPLANTED DEVICE. TROUBLESHOOTING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. THERE ARE PLANS TO EXPLANT THE DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 25439347 ↗
• InjuryMay 22, 2026Migration

  PER THE CLINIC, THE PATIENT EXPERIENCED A MIGRATION OF IMPLANT DURING AN MRI (1.5 TESLA) ON (B)(6) 2026. IT WAS REPORTED THE CLINICIAN DID NOT FOLLOW THE MANUFACTURER'S INSTRUCTIONS FOR USE OF MRI. SUBSEQUENTLY, THE PATIENT DEVELOPED A CRUST-LIKE SKIN LESION AND WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Localized Skin Lesion

  MAUDE report 25251239 ↗
• InjuryMay 21, 2026Noise, Audible

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOUD, BOOMING SOUND, DISCOMFORT AND DIZZINESS WITH THE DEVICE USE. THE PATIENT ENDED UP BEING A NON-USER. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: Discomfort; Dizziness

  MAUDE report 25250627 ↗
• InjuryMay 20, 2026Circuit Failure; Positioning Failure; Output Problem; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT WAS IMPLANTED AT A LATE STAGE FOLLOWING MENINGITIS, RESULTING IN COCHLEAR CLOSURE AND INCOMPLETE ELECTRODE INSERTION INTO THE COCHLEA. THE CLINICIANS INITIALLY ELECTED TO MONITOR THE PATIENT TO DETERMINE WHETHER RESPONSES COULD BE OBTAINED FROM THE IMPLANTED ELECTRODES OVER TIME; HOWEVER, NO RESPONSE WAS OBSERVED. THE CLINIC ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN/NON-AUDITORY SENSATIONS AND POOR DEVICE PERFORMANCE SINCE ACTIVATION. PRIOR TO EXPLANTATION, DEVICE TESTING CONFIRMED THAT THE DEVICE WAS FUNCTIONING; HOWEVER, 15 ELECTRODES WERE REPORTED AS OPEN CIRCUIT DUE TO MENINGITIS, WHILE THE IMPEDANCE OF THE REMAINING 7 ELECTRODES WAS WITHIN NORMAL LIMITS. ADDITIONALLY, THE PATIENT REQUIRED AN MRI OF THE HEAD REGION DUE TO ONGOING HEALTH ISSUES UNRELATED TO THE COCHLEAR DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. AS OF THE DATE OF THIS REPORT, THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE.

  Patient problems: Pain

  MAUDE report 25237329 ↗
• InjuryMay 18, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH THE DEVICE. HARDWARE EXCHANGE AND 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 25211528 ↗
• InjuryMay 18, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH THE DEVICE. HARDWARE EXCHANGE AND 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 25211524 ↗
• InjuryMay 14, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT SUFFERS A HEAD TRAUMA WHICH LEADS TO HEMATOMA FORMATION (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS ON (B)(6) 2026 (SPECIFIC DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Head Injury; Hematoma

  MAUDE report 25173315 ↗
• InjuryMay 13, 2026Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE DEVICE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA.

  Patient problems: Head Injury; Tissue Breakdown

  MAUDE report 25157456 ↗
• MalfunctionMay 7, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AT THE IMPLANT SITE AND MAGNET DISLODGEMENT FOLLOWING AN MRI (1.5 TESLA) IN (B)(6) 2025 (SPECIFIC DATE NOT REPORTED). SURGERY TO REPOSITION THE MAGNET UNDER GENERAL ANESTHESIA WAS COMPLETED ON (B)(6) 2026, AND THE MAGNET WAS CONFIRMED INTRAOPERATIVELY TO BE DISLODGED AND COMPLETELY OUTSIDE ITS POCKET. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Implant Pain

  MAUDE report 25109130 ↗

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.