Cochlear® Nucleus® Nexa™ cochlear implant CI1012Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 09321502069847), received between Sep 7, 2025 and Sep 23, 2026 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6) 2026 due to an infection (site of infection not confirmed). There are plans to reimplant the patient with a new 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: Unspecified Infection

  MAUDE report 50863672 ↗
• InjurySep 22, 2026Failure to Deliver Shock/Stimulation; Malposition of Device; Electrical Shorting; Patient Device Interaction Problem

  Per the clinic, the patient underwent revision surgery (device repositioning) under general anesthesia on (b)(6) 2026. Following the implant activation, a short circuit was detected on electrode 22. Followed by that, the patient experienced no NRT and absence of sound perception. Reprogramming attempts were made; however, the issue could not be resolved. The implanted device remains. 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 50850350 ↗
• InjurySep 21, 2026Positioning Failure; Migration

  Per the clinic, the patient experienced electrode migration/incorrect placement. 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 50836189 ↗
• InjurySep 20, 2026Positioning Failure

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

  MAUDE report 50834807 ↗
• InjurySep 20, 2026Positioning Failure

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

  MAUDE report 50834806 ↗
• InjuryAug 28, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6) 2026, due to an infection (site of infection not confirmed). 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: Unspecified Infection

  MAUDE report 50490894 ↗
• InjuryAug 27, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Calibration Problem; Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced sounds too soft, pain/non-auditory sensations, poor performance with the device, vertigo and a half sided facial paralysis on the side of the implant. The impedances has also increased and some channels were out of compliance which leads to device nonuse. The patient was subsequently hospitalized for administration of IV cortisone and antibiotics. The facial paralysis was resolved after two days and the impedance level normalized. The patient was discharged on (b)(6), 2025. However, the impedances increased again two days later, and eleven electrodes were out of compliance one week later. Reprogramming attempts were made, however the issue did not resolved. The patient was hospitalized again on (b)(6), 2025. The external sound processor remained switched off and the next day, the impedances dropped significantly. The patient was administered with another round of steroid treatment during the second hospitalization on (b)(6), 2025. The high impedance was normalized again after two days. Reprogramming were attempted again, however the issue did not resolved. Subsequently, the device was explanted on (b)(6), 2026.

  Patient problems: Facial Paralysis; Pain; Vertigo

  MAUDE report 50465996 ↗
• InjuryJul 30, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced a diffuse middle ear inflammation with cholesteatoma in the mesotympanum and fluid (otorrhea) around the implant body and electrode. Subsequently, 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: Fluid Discharge; Middle Ear Inflammation

  MAUDE report 50079674 ↗
• InjuryJul 30, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced a diffuse middle ear inflammation with cholesteatoma in the mesotympanum and fluid (otorrhea) around the implant body and electrode. Subsequently, 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: Fluid Discharge; Middle Ear Inflammation

  MAUDE report 50079672 ↗
• InjuryJul 27, 2026Malposition of Device; Migration

  Per the clinic, the device was explanted on (b)(6) 2026 due to incorrect placement/migration of the device. The patient was reimplanted with a new 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 50024812 ↗
• InjuryJul 27, 2026Failure to Deliver Shock/Stimulation; Malposition of Device

  Per the clinic, the patient experienced no sound perception. It was also reported that the electrode array was not in the cochlea. 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 50012154 ↗
• InjuryJul 27, 2026Failure to Deliver Shock/Stimulation; Malposition of Device

  Per the clinic, the patient experienced no sound perception. It was also reported that the electrode array was not in the cochlea. 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 50012152 ↗
• InjuryJun 19, 2026Difficult to Advance; Patient Device Interaction Problem

  PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO NO NRT FROM INTRAOPERATIVE TESTING AND RESISTANCE DURING INSERTION, CRIMPING THE DEVICE. THE PATIENT WAS REIMPLANTED WITH A NEW 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 25557220 ↗
• InjuryJun 14, 2026Positioning Failure

  PER THE CLINIC, THE ELECTRODE ARRAY WAS PARTIALLY INSERTED IN THE COCHLEA. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2026 IN ATTEMPT TO INSERT THE ELECTRODE ARRAY FURTHER, HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497832 ↗
• InjuryMay 14, 2026Positioning Failure

  PER THE CLINIC, THE ELECTRODE WAS ACCIDENTALLY PLACED INTO VESTIBULE DURING THE SURGERY DUE TO ABNORMAL ANATOMY. IT WAS REPORTED THAT, POST OPERATIVE CT SCAN WAS PERFORMED AND REVEALED THAT THE IMPLANT WAS PLACED INTO VESTIBULE, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. 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 25179596 ↗
• InjuryMay 14, 2026Positioning Failure

  PER THE CLINIC, THE ELECTRODE WAS ACCIDENTALLY PLACED INTO VESTIBULE DURING THE SURGERY DUE TO ABNORMAL ANATOMY. IT WAS REPORTED THAT, POST OPERATIVE CT SCAN WAS PERFORMED AND REVEALED THAT THE IMPLANT WAS PLACED INTO VESTIBULE, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. 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 25179589 ↗
• InjuryMay 12, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION, SWELLING AND FLUID ACCUMULATION AROUND THE RECEIVER/STIMULATOR SITE. THE PATIENT WAS SUBSEQUENTLY TREATED WITH A PRESSURE HEADWRAP, ANTIBIOTICS THERAPY (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED), AND SURGICAL INTERVENTION REQUIRING A THREE-NIGHT INPATIENT HOSPITAL STAY (SPECIFIC DATE 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: Bacterial Infection; Medical device site infection; Swelling/ Edema

  MAUDE report 25145956 ↗
• InjuryMay 12, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION, SWELLING AND FLUID ACCUMULATION AROUND THE RECEIVER/STIMULATOR SITE. THE PATIENT WAS SUBSEQUENTLY TREATED WITH A PRESSURE HEADWRAP, ANTIBIOTICS THERAPY (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED), AND SURGICAL INTERVENTION REQUIRING A THREE-NIGHT INPATIENT HOSPITAL STAY (SPECIFIC DATE 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: Bacterial Infection; Medical device site infection; Swelling/ Edema

  MAUDE report 25145955 ↗
• InjuryApr 22, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, DUE TO AN INFECTION (SITE OF INFECTION NOT CONFIRMED). THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 24961468 ↗
• InjuryApr 1, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED PERILYMPH LEAK DUE TO LARGE VESTIBULAR AQUEDUCT. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND UNDERWENT REVISION SURGERY ON (B)(6) 2026 TO STOP PERILYMPH LEAK FROM COCHLEA. THE IMPLANTED DEVICE REMAINS.

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

  MAUDE report 24751186 ↗
• InjuryMar 25, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). THE DEVICE WAS EXPLANTED ON (B)(6) 2026 AND IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 24683974 ↗
• InjuryMar 13, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED A WOUND INFECTION THREE WEEKS FOLLOWING DEVICE ACTIVATION. THE PATIENT WAS SUBSEQUENTLY TREATED WITH ANTIBIOTIC THERAPY (TYPE NOT REPORTED). THE INFECTION WAS REPORTED TO HAVE RESOLVED. THE IMPLANTED DEVICE REMAINS IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 24596716 ↗
• InjuryMar 13, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED A WOUND INFECTION THREE WEEKS FOLLOWING DEVICE ACTIVATION. THE PATIENT WAS SUBSEQUENTLY TREATED WITH ANTIBIOTIC THERAPY (TYPE NOT REPORTED). THE INFECTION WAS REPORTED TO HAVE RESOLVED. THE IMPLANTED DEVICE REMAINS IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 24588205 ↗
• InjuryMar 6, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2026. IT IS UNKNOWN IF THERE ARE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24527880 ↗
• InjuryMar 2, 2026Appropriate Device Problem Term/Code Not Available; Migration

  PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 TO REPOSITION THE RECEIVER-STIMULATOR DUE TO UNKNOWN REASON. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT 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 24492609 ↗

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.