Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode CI1032Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 09321502053099), received between Nov 12, 2025 and Sep 29, 2026 — classified as 83 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (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 87 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, a lesion was observed at the surgical scar site. The patient was subsequently hospitalized in (b)(6) 2026 (specific date not reported) due to an infection at the implant site and was treated with antibiotics (specific type, date and duration not reported).

  Patient problems: Fistula; Localized Skin Lesion; Medical device site infection

  MAUDE report 50934214 ↗
• InjurySep 25, 2026Malposition of Device

  Per the clinic, the patient experienced electrode lead displacement during the initial implantation surgery, with the electrode array partially inserted and positioned in the mastoid cavity. Subsequently, the patient underwent repositioning surgery on (b)(6) 2026 during which the device was inserted into a new sheath and reimplanted into the cochlea.The implanted device remains.

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

  MAUDE report 50897574 ↗
• InjurySep 25, 2026Malposition of Device

  Per the clinic, the patient experienced electrode lead displacement during the initial implantation surgery, with the electrode array partially inserted and positioned in the mastoid cavity. Subsequently, the patient underwent repositioning surgery on(b)(6) 2026 during which the device was inserted into a new sheath and reimplanted into the cochlea.The implanted device remains.

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

  MAUDE report 50897573 ↗
• MalfunctionSep 23, 2026Circuit Failure; Failure to Deliver Shock/Stimulation

  Per the clinic, open circuits were noted on all electrodes during initial surgery and activation. The device could not be programmed, hence, the patient received no sound with the device. Troubleshooting attempts were made; however, the issue could not be resolved. The implanted device remains. There are plans to explant the device and to reimplant the patient with a new 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 50863899 ↗
• MalfunctionSep 23, 2026Circuit Failure; Failure to Deliver Shock/Stimulation

  Per the clinic, open circuits were noted on all electrodes during initial surgery and activation. The device could not be programmed, hence, the patient received no sound with the device. Troubleshooting attempts were made; however, the issue could not be resolved. The implanted device remains. There are plans to explant the device and to reimplant the patient with a new 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 50863895 ↗
• InjurySep 21, 2026Circuit Failure; Electrical Shorting

  Patient problems: Failure of Implant

  MAUDE report 50847551 ↗
• InjurySep 21, 2026Circuit Failure; Electrical Shorting

  Patient problems: Failure of Implant

  MAUDE report 50847550 ↗
• InjurySep 21, 2026Failure to Deliver Shock/Stimulation

  Per the clinic, the patient experienced no benefit from 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50835426 ↗
• InjurySep 21, 2026Failure to Deliver Shock/Stimulation

  Per the clinic, the patient experienced no benefit from 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50835425 ↗
• InjurySep 17, 2026Failure to Deliver Shock/Stimulation; Positioning Failure

  Per the clinic, the patient experienced no sound perception during activation due to electrode that was left in cochlea from previous implant had migrated out of cochlear. Hardware exchange, troubleshooting and reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6)2026. 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 50801381 ↗
• InjurySep 17, 2026Failure to Deliver Shock/Stimulation; Positioning Failure

  Per the clinic, the patient experienced no sound perception during activation due to electrode that was left in cochlea from previous implant had migrated out of cochlear. Hardware exchange, troubleshooting and reprogramming attempts were made; however, the issue could not be resolved. The device was explanted on (b)(6) 2026. 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 50801380 ↗
• InjurySep 15, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted (date not reported) 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. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Unspecified Infection

  MAUDE report 50768532 ↗
• InjurySep 15, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted (date not reported) 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. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Unspecified Infection

  MAUDE report 50768530 ↗
• InjurySep 14, 2026Failure to Deliver Shock/Stimulation

  Per the clinic, the device was explanted on (b)(6) 2026 due to no response to stimulation after activation. The patient was not reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748056 ↗
• InjurySep 14, 2026Failure to Deliver Shock/Stimulation

  Per the clinic, the device was explanted on (b)(6), 2026 due to no response to stimulation after activation. The patient was not reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748055 ↗
• InjurySep 11, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6) 2026 due to an infection (site not confirmed). There are plans to re-implant the patient, however, it has not been performed as of this date of report.

  Patient problems: Unspecified Infection

  MAUDE report 50727991 ↗
• MalfunctionSep 11, 2026Circuit Failure; Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced a performance decrement and open circuits were noted on multiple electrodes. Troubleshooting and reprogramming attempts were made; however, the issue could not be resolved. The implanted device remains.There are no plans to explant and reimplant the patient as of this date of report.

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

  MAUDE report 50727989 ↗
• MalfunctionSep 11, 2026Circuit Failure; Therapeutic or Diagnostic Output Failure

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

  MAUDE report 50727984 ↗
• InjurySep 2, 2026Circuit Failure; Failure to Deliver Shock/Stimulation

  Patient problems: Swelling/ Edema

  MAUDE report 50557693 ↗
• InjurySep 2, 2026Circuit Failure; Failure to Deliver Shock/Stimulation

  Patient problems: Swelling/ Edema

  MAUDE report 50557692 ↗
• InjurySep 2, 2026Expulsion

  Patient problems: Necrosis; Tissue Breakdown

  MAUDE report 50555206 ↗
• InjurySep 2, 2026Expulsion

  Per the clinic, the patient experienced a pressure necrosis of the skin under the magnet site, exposing the receiver/stimulator. 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: Necrosis; Tissue Breakdown

  MAUDE report 50555202 ↗
• InjuryAug 27, 2026Expulsion

  Per the clinic, the device was explanted on (b)(6) 2026 due to extrusion of receiver/stimulator. 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: Tissue Breakdown

  MAUDE report 50468629 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection (site of infection not confirmed) and was treated with two rounds of IV antibiotics (specific date not reported). Subsequently, the device was explanted on (b)(6) 2026. Reimplantation is planned once the infection has resolved, but had not taken place at the time 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 50404153 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection (location and date not reported). Subsequently, the device was explanted (date not reported). Re-implantation is planned but had not taken place at the time 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 50402146 ↗

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.