Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,057 adverse event reports that list this exact device (DI 09321502036580), received between Sep 18, 2019 and Sep 25, 2026 — classified as 1,984 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Expulsion” (352 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 2,057 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Signal Artifact/Noise; Circuit Failure

  Per the clinic, the patient experienced static sound with the device. Open circuits were noted on all electrodes. Hardware exchange and 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: Headache; Numbness

  MAUDE report 50893232 ↗
• MalfunctionSep 25, 2026Signal Artifact/Noise; Circuit Failure

  Per the clinic, the patient experienced static sound with the device. Open circuits were noted on all electrodes. Hardware exchange and 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: Headache; Numbness

  MAUDE report 50893231 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted on (b)(6)2026, due to patient requiring serial MRIs. 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 50878482 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted on (b)(6)2026, due to patient requiring serial MRIs. 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 50878479 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient developed drainage and a infection at the implant site after the implant surgery in 2025. The patient was subsequently treated with oral antibiotics (specific date and duration not reported) and the issue resolved.

  Patient problems: Fluid Discharge; Medical device site infection

  MAUDE report 50877666 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient developed drainage and a infection at the implant site after the implant surgery in 2025. The patient was subsequently treated with oral antibiotics (specific date and duration not reported) and the issue resolved.

  Patient problems: Fluid Discharge; Medical device site infection

  MAUDE report 50877665 ↗
• InjurySep 22, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection and oozing at the incision site. The device is subsequently explanted on (b)(6) 2026. The infected site was cleaned during the explant surgery. Re-implantation is planned but had not taken place at the time of this report.

  Patient problems: Fluid Discharge; Medical device site infection

  MAUDE report 50850354 ↗
• InjurySep 22, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection and oozing at the incision site. The device is subsequently explanted on (b)(6) 2026. The infected site was cleaned during the explant surgery. Reimplantation is planned but had not taken place at the time of this report.

  Patient problems: Fluid Discharge; Medical device site infection

  MAUDE report 50850348 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted (date not reported) due to unknown reason. The patient was re-implanted with another cochlear device on (b)(6)2026. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Insufficient Information

  MAUDE report 50836191 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Per the clinic, the device was explanted (date not reported) due to unknown reason. The patient was reimplanted with another cochlear device on (b)(6) 2026. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Insufficient Information

  MAUDE report 50836190 ↗
• InjurySep 21, 2026Expulsion

  Per the clinic, the patient experienced skin breakdown at the magnet site, exposing the receiver/stimulator (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: Tissue Breakdown

  MAUDE report 50835047 ↗
• InjurySep 21, 2026Expulsion

  Per the clinic, the patient experienced skin breakdown at the magnet site, exposing the receiver/stimulator (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: Tissue Breakdown

  MAUDE report 50835046 ↗
• InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6) 2026; due to pain. It is unknown if there are plans to reimplant the patient as of the date of this report.

  Patient problems: Pain

  MAUDE report 50813093 ↗
• InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was explanted on (b)(6), 2026; due to pain. It is unknown if there are plans to reimplant the patient as of the date of this report.

  Patient problems: Pain

  MAUDE report 50813092 ↗
• InjurySep 15, 2026Contamination; Expulsion

  Per the clinic, the patient experienced a skin breakdown and skin lesion at the implant site, implant extrusion, and contamination of the implant (specific date not reported), following a head trauma. Subsequently, the device was explanted on(b)(6) 2026, and there are no plans to reimplant the patient with a new device as of the date of this report.

  Patient problems: Head Injury; Tissue Breakdown

  MAUDE report 50766861 ↗
• MalfunctionSep 11, 2026Circuit Failure; Failure to Deliver Shock/Stimulation

  Per the clinic, the patient experienced a loss of sound with the device use and open circuits were noted on all electrodes. The device remains implanted. 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 50727328 ↗
• 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 of infection 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 50726119 ↗
• 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 of infection 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 50726117 ↗
• MalfunctionSep 10, 2026Circuit Failure; Failure to Deliver Shock/Stimulation; Output Problem; Therapeutic or Diagnostic Output Failure

  Patient problems: Head Injury

  MAUDE report 50706359 ↗
• MalfunctionSep 10, 2026Circuit Failure; Failure to Deliver Shock/Stimulation; Output Problem; Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient sustained a head impact on (b)(6) 2026. Subsequently, the patient experienced no sound and poor performance with the device use. An open circuit was noted on 19 electrodes. Hardware exchange 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: Head Injury

  MAUDE report 50706358 ↗
• InjurySep 8, 2026Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced minimal benefit with the device. 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 a transcutaneous Osia Implant System during the same surgery.

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

  MAUDE report 50662310 ↗
• InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available

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

  MAUDE report 50563659 ↗
• InjurySep 2, 2026Circuit Failure; Decreased Sensitivity; Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient developed progressive cholesteatoma in (b)(6) 2025 (specific date not reported), resulting in a markedly enlarged mastoid cavity with the electrode lead visibly exposed within the cavity. Hearing performance was initially stable; however, the patient reported sudden hearing loss in approximately early (b)(6) 2026. Reprogramming attempts were made; however, the issue could not be resolved. Subsequently, the device was explanted on (b)(6) 2026. During surgery, the electrode placement site was cleansed, and pus was observed within the cochlea. Postoperative antibiotics (specific type, date and duration not reported) were administered to treat the infection. The patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Cholesteatoma; Mastoiditis; Purulent Discharge

  MAUDE report 50558992 ↗
• InjurySep 2, 2026Expulsion

  Per the clinic, the patient developed an infection with an open wound and device exposure. The patient also developed a postauricular abscess. The patient was treated with antibiotics (specific type, date and duration not reported). 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: Abscess; Medical device site infection; Tissue Breakdown

  MAUDE report 50558990 ↗
• InjuryAug 27, 2026Expulsion

  Per the clinic, the device was explanted on (b)(6) 2026, due to the implant extruding through the skin with surrounding infection.

  Patient problems: Medical device site infection; Tissue Breakdown

  MAUDE report 50466924 ↗

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.