Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrode CI1022Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 09321502053082), received between Aug 8, 2025 and Sep 28, 2026 — classified as 67 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (16 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 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced discomfort, abscess, and bacterial infection around receiver/simulator and in mastoid (specific date not reported). The patient initially underwent incision and drainage procedure and received a 4 week course antibiotics (specific date and type not reported). Subsequently, 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: Abscess; Bacterial Infection; Discomfort; Mastoiditis; Medical device site infection; Post Operative Wound Infection

  MAUDE report 50910750 ↗
• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced discomfort, abscess, and bacterial infection around receiver/simulator and in mastoid (specific date not reported). The patient initially underwent incision and drainage procedure and received a 4 week course antibiotics (specific date and type not reported). Subsequently, the device was explanted on (b)(6) 2026. There are plans to re-implant the patient with a new device; however, this has not occurred as of the date of this report.

  Patient problems: Abscess; Bacterial Infection; Discomfort; Mastoiditis; Medical device site infection; Post Operative Wound Infection

  MAUDE report 50910749 ↗
• MalfunctionSep 22, 2026Failure to Read Input Signal; Impedance Problem

  Per the clinic, the patient experienced no connection to the internal device during activation and no impedances could be measured. Troubleshooting attempts and hardware exchange at the clinic did not resolve the issue and the clinic requested a Cochlear specialist to verify the device function. The implanted device remains in-situ. 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 50850040 ↗
• InjurySep 19, 2026Unexpected Therapeutic Results; Malposition of Device; Therapeutic or Diagnostic Output Failure

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

  MAUDE report 50832382 ↗
• InjurySep 19, 2026Unexpected Therapeutic Results; Malposition of Device; Therapeutic or Diagnostic Output Failure

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

  MAUDE report 50832381 ↗
• InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced migraines both with and without device stimulation, resulting in the patient's decision not to use the device. The device was subsequently 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: Headache

  MAUDE report 50799282 ↗
• InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced migraines both with and without device stimulation, resulting in the patient's decision not to use the device. The device was subsequently 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: Headache

  MAUDE report 50799279 ↗
• InjurySep 17, 2026Biofilm coating in Device

  Per the clinic, the patient experienced pain and infection (biofilm) at the implant site (specific date not reported). Subsequently, the device was explanted on (b)(6) 2026. There are plans to re-implant the patient with a new device; however, this had not occurred as of the date of this report.

  Patient problems: Medical device site infection; Pain

  MAUDE report 50797319 ↗
• InjurySep 16, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782708 ↗
• InjuryAug 26, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection (site of infection not confirmed). Subsequently, the patient was underwent revision surgery in order to re-positioned the receiver/stimulator on (b)(6) 2026. However, it was discovered that the intracochlear electrode wire was inadvertently damaged during the procedure. The receiver/stimulator was then explanted, while the intracochlear electrode array was left in the cochlea, with reimplantation planned at a later date (specific date not reported). Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Unspecified Infection

  MAUDE report 50448313 ↗
• InjuryAug 26, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection (site of infection not confirmed). Subsequently, the patient was underwent revision surgery in order to repositioned the receiver/stimulator on (b)(6) 2026. However, it was discovered that the intracochlear electrode wire was inadvertently damaged during the procedure. The receiver/stimulator was then explanted, while the intracochlear electrode array was left in the cochlea, with reimplantation planned at a later date (specific date not reported). Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Unspecified Infection

  MAUDE report 50448312 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient developed skin infection behind the ear. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Skin Infection

  MAUDE report 50399276 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient developed skin infection behind the ear. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Skin Infection

  MAUDE report 50399274 ↗
• MalfunctionAug 5, 2026Circuit Failure; Output Problem

  Patient problems: Head Injury

  MAUDE report 50137775 ↗
• InjuryJul 31, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted (specifc date not reported) for unknown reasons. The patient was reimplanted with another cochlear device (specific date not reported). Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Insufficient Information

  MAUDE report 50096192 ↗
• InjuryJul 31, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted (specifc date not reported) for unknown reasons. The patient was reimplanted with another cochlear device (specific date not reported). Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Insufficient Information

  MAUDE report 50096191 ↗
• InjuryJul 27, 2026Positioning Failure

  Per the clinic, the tip of the electrode array was inserted and found to be folded over in the cochlea, resulting in the decision to explant the device. The device was explanted (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50033528 ↗
• InjuryJul 27, 2026Circuit Failure

  Per the clinic, open circuits were noted on 2 electrodes intraoperatively, followed by detection of open circuits on further 3 electrodes during the initial fitting impedance measurement on (b)(6) 2024. Reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6) 2026, and the patient was implanted with a new device during the same surgery.

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

  MAUDE report 50024908 ↗
• InjuryJun 10, 2026Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CLINIC, THE PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION AFFECTING BOTH THE MIDDLE EAR AND THE IMPLANT SITE. MICROBIAL CULTURES OBTAINED FROM SWABS OF THE IMPLANT SITE TESTED POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND TREATED WITH INTRAVENOUS ANTIBIOTICS; HOWEVER, THE CONDITION DID NOT RESOLVE. CONSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. AS OF THE DATE OF THIS REPORT, IT IS UNKNOWN WHETHER THERE ARE PLANS FOR REIMPLANTATION.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 25453855 ↗
• InjuryJun 8, 2026Positioning Failure

  PER THE CLINIC, TIP FOLD OVER WAS OBSERVED WITH THE DEVICE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2026 IN ORDER TO REPOSITION THE DEVICE.

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

  MAUDE report 25422781 ↗
• InjuryJun 4, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK FROM THE LEFT EAR AND NOSTRIL TWO DAYS FOLLOWING SURGERY, REQUIRING URGENT RETURN TO THE OPERATING ROOM FOR A LEFT SUBTOTAL PETROSECTOMY AND BLIND SAC CLOSURE. IN EARLY (B)(6) 2026 (SPECIFIC DATE NOT REPORTED), THE PATIENT WAS ADMITTED TO THE HOSPITAL (DATE AND DURATION NOT REPORTED) WITH COVID-19 AND HIGH FEVERS, AND DRAINAGE WAS NOTED AT THE SURGICAL INCISION SITE. ON APRIL 6, 2026, CULTURES OF THE DRAINAGE WERE POSITIVE FOR MRSA, AND TREATMENT WITH ANTIBIOTICS WAS INITIATED ON (B)(6) 2026 (TYPE AND DURATION NOT REPORTED). BY (B)(6) 2026, THE DRAINAGE APPEARED TO BE IMPROVING WITH NO SIGNS OF ACTIVE INFECTION. HOWEVER, WORSENING SWELLING AT THE IMPLANT SITE AND ERYTHEMA OF THE POSTAURICULAR INCISION WERE OBSERVED. THE PATIENT UNDERWENT SURGICAL WASHOUT (DATE NOT REPORTED), WHICH REVEALED COPIOUS PURULENT MATERIAL CONSISTENT WITH INFECTION AT THE INCISION SITE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026. RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Cerebrospinal Fluid Leakage; Drug Resistant Bacterial Infection; Erythema; Fever; Purulent Discharge; Swelling/ Edema

  MAUDE report 25388030 ↗
• InjuryJun 4, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK FROM THE LEFT EAR AND NOSTRIL TWO DAYS FOLLOWING SURGERY, REQUIRING URGENT RETURN TO THE OPERATING ROOM FOR A LEFT SUBTOTAL PETROSECTOMY AND BLIND SAC CLOSURE. IN EARLY (B)(6) 2026 (SPECIFIC DATE NOT REPORTED), THE PATIENT WAS ADMITTED TO THE HOSPITAL (DATE AND DURATION NOT REPORTED) WITH COVID-19 AND HIGH FEVERS, AND DRAINAGE WAS NOTED AT THE SURGICAL INCISION SITE. ON (B)(6) 2026, CULTURES OF THE DRAINAGE WERE POSITIVE FOR MRSA, AND TREATMENT WITH ANTIBIOTICS WAS INITIATED ON (B)(6) 2026 (TYPE AND DURATION NOT REPORTED). BY (B)(6) 2026, THE DRAINAGE APPEARED TO BE IMPROVING WITH NO SIGNS OF ACTIVE INFECTION. HOWEVER, WORSENING SWELLING AT THE IMPLANT SITE AND ERYTHEMA OF THE POSTAURICULAR INCISION WERE OBSERVED. THE PATIENT UNDERWENT SURGICAL WASHOUT (DATE NOT REPORTED), WHICH REVEALED COPIOUS PURULENT MATERIAL CONSISTENT WITH INFECTION AT THE INCISION SITE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Cerebrospinal Fluid Leakage; Drug Resistant Bacterial Infection; Erythema; Fever; Purulent Discharge; Swelling/ Edema

  MAUDE report 25388000 ↗
• InjuryJun 4, 2026Expulsion

  PER THE CLINIC, THE PATIENT SUSTAINED A FALL FOLLOWING THE IMPLANTATION AND WAS REPORTED TO HAVE POOR WOUND HEALING. APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT DEVELOPED GRANULATION TISSUE AT THE POST-AURICULAR INCISION SITE. ONE MONTH LATER, THE PATIENT EXPERIENCED WOUND DEHISCENCE RESULTING IN EXPOSURE OF THE IMPLANT. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A WOUND WASHOUT PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, INFECTION WAS OBSERVED LEADING TO THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection; Fall; Impaired Healing; Wound Dehiscence

  MAUDE report 25387386 ↗
• InjuryMay 22, 2026Positioning Failure

  PER THE REPORTING CLINIC, THE PATIENT EXPERIENCED INCORRECT IMPLANT POSITIONING DURING THE INITIAL IMPLANTATION ON (B)(6) 2026, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253341 ↗
• InjuryMay 22, 2026Positioning Failure

  PER THE REPORTING CLINIC, THE PATIENT EXPERIENCED INCORRECT IMPLANT POSITIONING DURING THE INITIAL IMPLANTATION ON (B)(6) 2026, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253338 ↗

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.