Cochlear® Nucleus® CI532 cochlear Implant with Slim Modiolar electrodeRecalls & reported problems

Summary

The FDA's MAUDE database contains 837 adverse event reports that list this exact device (DI 09321502032612), received between Nov 17, 2016 and Sep 23, 2026 — classified as 731 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (100 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 837 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Unexpected Therapeutic Results; Therapeutic or Diagnostic Output Failure; Unstable Impedance

  Per the clinic, the patient experienced a decrement in sound quality and speech perception; and fluctuating impedance measurements with the implanted device. The patient also experienced dizziness, a decrease in stability when walking, pain and a pumping sensation at the implant site. Troubleshooting and reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6) 2026 and the patient was re-implanted with a new device during the same surgery.

  Patient problems: Balance Problems; Dizziness; Implant Pain

  MAUDE report 50863699 ↗
• MalfunctionSep 18, 2026Circuit Failure

  Per the clinic, it was reported that open circuits were noted on 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. 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 50813620 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted on (b)(6) 2026, for unknown reasons. 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: Insufficient Information

  MAUDE report 50728115 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was explanted on (b)(6) 2026, due to MRI needs and there are no plans to re-implant the patient with a new device as of the date of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726849 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted on (b)(6) 2026, for unknown reasons. 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: Insufficient Information

  MAUDE report 50726848 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was explanted on (b)(6) 2026, due to MRI needs and there are no plans to reimplant the patient with a new device as of the date of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726847 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6) 2025, 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.

  Patient problems: Unspecified Infection

  MAUDE report 50401521 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6) 2025, due to an infection (site of infection not confirmed). It is unknown if there are plans to re-implant the patient as of the date of this report

  Patient problems: Unspecified Infection

  MAUDE report 50401517 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted on (b)(6) 2026, due to the need for MRI imaging. There are no plans to reimplant the patient with a new device as of the date of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50095017 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted on (b)(6)2026, due to the need for MRI imaging. There are no plans to reimplant the patient with a new device as of the date of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50095015 ↗
• InjuryJul 27, 2026Device Dislodged or Dislocated

  Per the clinic, the recipient experienced burning pain and pressure at the implant site, which persisted following an MRI procedure. The surgeon observed a semi-lunar impression beneath the scalp that was reportedly not present prior to the MRI. Based on the clinical findings, the surgeon suspected that the implant magnet had shifted and that the receiver/stimulator may have displaced from its implant bed. However, a CT scan confirmed that the implant array remained in situ. Subsequently, surgery to reposition the magnet was completed on (b)(6) 2026. The implanted device remains.

  Patient problems: Implant Pain

  MAUDE report 50024815 ↗
• MalfunctionJun 26, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DURING AN MRI (1.5 TESLA). THE PATIENT'S HEAD WAS WRAPPED AS RECOMMENDED BY COCHLEAR. THE PATIENT ATTEMPTED EXTERNAL MANIPULATION OF THE DISLODGED MAGNET BACK INTO PLACE; HOWEVER, IT DID NOT REMAIN IN PLACE. IN APRIL, THE SURGEON SUCCESSFULLY REPOSITIONED THE DISLODGED MAGNET BACK INTO PLACE BY EXTERNAL MANIPULATION; HOWEVER, THE MAGNET BECAME DISLODGED AGAIN IN EARLY MAY (SPECIFIC DATE NO REPORTED). EXPLANT AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632025 ↗
• MalfunctionJun 24, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT (SPECIFIC DATE NOT REPORTED). SURGERY TO REPLACE THE MAGNET UNDER GENERAL ANESTHESIA HAS BEEN COMPLETED ON (B)(6) 2026. THE IMPLANTED DEVICE REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616905 ↗
• InjuryJun 11, 2026Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE FROM ACTIVATION, LEADING TO DEVICE NON-USE. ADDITIONALLY, THE DEVICE WAS REPORTED TO HAVE LIMITED MRI COMPATIBILITY. SUBSEQUENTLY, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2026. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

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

  MAUDE report 25467322 ↗
• InjuryMay 22, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DURING AN MRI (SPECIFIC TESLA NOT REPORTED) FOLLOWED BY DISCOMFORT WHEN WEARING AN EXTERNAL. SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(6) 2023. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Discomfort

  MAUDE report 25250979 ↗
• InjuryMay 22, 2026Device Dislodged or Dislocated

  PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DURING AN MRI (SPECIFIC TESLA NOT REPORTED) FOLLOWED BY DISCOMFORT WHEN WEARING AN EXTERNAL. SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(6) 2023. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Discomfort

  MAUDE report 25250978 ↗
• MalfunctionMay 18, 2026Signal Artifact/Noise; High impedance; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED LOUD NOISE, DISCOMFORT, AND POOR PERFORMANCE WITH THE DEVICE. HARDWARE EXCHANGE, TROUBLESHOOTING AND RE-PROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. HIGH IMPEDANCE WAS OBSERVED IN SEVERAL ELECTRODES. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Discomfort

  MAUDE report 25200507 ↗
• InjuryMay 12, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO AN INFECTION (SITE NOT CONFIRMED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 25146751 ↗
• InjuryMay 12, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO AN INFECTION (SITE NOT CONFIRMED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 25146727 ↗
• InjuryMay 5, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026 DUE TO INFECTION (CELLULITIS) AT THE MAGNET/RECEIVER STIMULATOR SITE. 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: Cellulitis

  MAUDE report 25089765 ↗
• InjuryMay 5, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026 DUE TO INFECTION (CELLULITIS) AT THE MAGNET/RECEIVER STIMULATOR SITE. 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: Cellulitis

  MAUDE report 25089764 ↗
• InjuryMay 4, 2026Positioning Problem; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR DEVICE PERFORMANCE SINCE INITIAL ACTIVATION, WHICH WAS ATTRIBUTED TO PARTIAL ELECTRODE INSERTION AND REDUCED FUNCTIONALITY. THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT DURING THE SAME SURGICAL PROCEDURE.

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

  MAUDE report 25064508 ↗
• InjuryMay 4, 2026Positioning Problem; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED POOR DEVICE PERFORMANCE SINCE INITIAL ACTIVATION, WHICH WAS ATTRIBUTED TO PARTIAL ELECTRODE INSERTION AND REDUCED FUNCTIONALITY. THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT DURING THE SAME SURGICAL PROCEDURE.

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

  MAUDE report 25064502 ↗
• InjuryApr 28, 2026Expulsion

  PER THE CLINIC, THE PATIENT EXPERIENCED TRAUMA TO THE IMPLANT SITE DURING PLAY WITH FATHER (SPECIFIC DATE NOT REPORTED), WHEN THE AREA WAS ACCIDENTALLY STRUCK BY HAND AND A BAT. FOLLOWING THIS INCIDENT, A HEMATOMA AND GRANULATION TISSUE WERE OBSERVED AT THE IMPLANT SITE. SUBSEQUENTLY, EXTRUSION OF THE IMPLANT AND INFECTION OCCURRED. THE PATIENT RECEIVED TREATMENT WITH ORAL ANTIBIOTICS (SPECIFIC DATES AND DURATION NOT REPORTED). THE DEVICE WAS EXPLANTED ON (B)(6) 2026. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Hematoma; Medical device site infection; Tissue Breakdown

  MAUDE report 25015562 ↗
• InjuryApr 27, 2026Failure to Deliver Shock/Stimulation; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED PROGRESSIVELY DECREASED BENEFIT TO THE POINT OF NO LONGER HEARING FROM THE IMPLANTED DEVICE DUE TO TUMORS GROWING MARKEDLY. THE DEVICE WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

  Patient problems: Solid Tumor

  MAUDE report 24994329 ↗

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.