Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,115 adverse event reports that list this exact device (DI 09321502036573), received between Nov 4, 2019 and Sep 29, 2026 — classified as 2,012 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Expulsion” (353 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 2,115 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Unexpected Therapeutic Results

  Per the clinic, the device was explanted on (b)(6) 2026 due to the poor sound quality. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50928074 ↗
• InjurySep 29, 2026Unexpected Therapeutic Results

  Per the clinic, the device was explanted on (b)(6) 2026 due to the poor sound quality. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50928069 ↗
• MalfunctionSep 28, 2026Circuit Failure; Failure to Read Input Signal; Output Problem

  Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Troubleshooting attempts were made; however, the issue could not be resolved. The implanted device remains. Open circuit was noted on 1 electrode.

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

  MAUDE report 50910892 ↗
• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced tinnitus, burning sensation, swelling over the magnet area, facial nerve stimulation, discomfort, pain and a reactive retroauricular lymph node was noted. The patient underwent antibiotic therapy (specific date not reported), which resulted in a reduction in the size of the retroauricular lymph node. Hardware exchange and reprogramming attempts were made; however, the issue could not be resolved. The implanted device remains in situ.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Skin Burning Sensation; Swelling/ Edema; Swollen Lymph Nodes/Glands; Tinnitus

  MAUDE report 50910891 ↗
• MalfunctionSep 28, 2026Circuit Failure; Failure to Read Input Signal; Output Problem

  Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Troubleshooting attempts were made; however, the issue could not be resolved. The implanted device remains. Open circuit was noted on 1 electrode.

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

  MAUDE report 50910889 ↗
• InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced uncontrollable flap infection at the implant site (date not reported). Subsequently, the device was explanted (specific date not reported). 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: Medical device site infection; Skin Infection

  MAUDE report 50898229 ↗
• MalfunctionSep 25, 2026No Device Output; Failure to Read Input Signal; Intermittent Shock/Stimulation

  Per the clinic, the patient experienced non-auditory stimulation, intermittent sound, yellow light flashed slowly and subsequent loss of connection to the internal device. Hardware exchange attempts were made; however, the issue could not be resolved. 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 50894384 ↗
• InjurySep 25, 2026Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced poor performance with the device and facial nerve stimulation after initial activation. Reprogramming attempts were made; however, the issue could not be resolved. Subsequently, the device was explanted on (b)(6) 2026, under general anesthesia and the patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50893138 ↗
• InjurySep 25, 2026Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced poor performance with the device and facial nerve stimulation after initial activation. Reprogramming attempts were made; however, the issue could not be resolved. Subsequently, the device was explanted on (b)(6) 2026, under general anesthesia and the patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50893137 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was electively explanted (specific date not reported) because the patient experienced a noticeable air pocket beneath the receiver/stimulator. The patient was reimplanted with another cochlear device.

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

  MAUDE report 50876807 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the device was electively explanted (specific date not reported) because the patient experienced a noticeable air pocket beneath the receiver/stimulator. The patient was reimplanted with another cochlear device.

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

  MAUDE report 50876806 ↗
• InjurySep 23, 2026Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced an infection (site of infection not confirmed) and a performance decrement. Subsequently, the device was explanted on (b)(6) 2026. It is unknown if there are plans to re-implant 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 50865750 ↗
• InjurySep 23, 2026Therapeutic or Diagnostic Output Failure

  Per the clinic, the patient experienced an infection (site of infection not confirmed) and a performance decrement. 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. Additional information has been requested but has not been made available as of the date of this report.

  Patient problems: Unspecified Infection

  MAUDE report 50865749 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted on (b)(6) 2026 due to a cholesteatoma. The patient was re-implanted with another cochlear device during the same surgery.

  Patient problems: Cyst(s)

  MAUDE report 50865503 ↗
• InjurySep 23, 2026High impedance

  Per the clinic, the patient developed a hematoma which subsequently led to an infection at the implant site after a magnet replacement surgery for MRI. It was also reported that the patient experienced loss of electrode function, high impedance and bone growth over the package. The patient was treated with oral antibiotics (specific date and duration not reported) and the device was explanted on (b)(6) 2026. The patient was not reimplanted.

  Patient problems: Hematoma; Medical device site infection

  MAUDE report 50864910 ↗
• MalfunctionSep 22, 2026Circuit Failure

  Per the clinic, the patient had very unreliable behavioral responses and typically cried with the external processors on or off. During the clinical appointment on (b)(6) 2026, impedance testing showed that all electrodes were open across the array in all modes. 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 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 50851017 ↗
• MalfunctionSep 22, 2026Circuit Failure

  Per the clinic, the patient had very unreliable behavioral responses and typically cried with the external processors on or off. During the clinical appointment on (b)(6) 2026, impedance testing showed that all electrodes were open across the array in all modes. 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 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 50851016 ↗
• InjurySep 22, 2026Malposition of Device

  Per the clinic, the tip of the electrode array was found to be folded over in the cochlea, resulting in the decision to explant the device. 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 50850139 ↗
• MalfunctionSep 22, 2026Circuit Failure; Failure to Deliver Shock/Stimulation; Unexpected Therapeutic Results; Noise, Audible

  Per the clinic, the patient experienced a small amount of swelling on top of pinna, with bruising and a small cut after sustaining a head impact. The patient is reportedly able to hear; however, the sound is fuzzy and beeping which eventually leads to a complete loss of sound percept. Open circuits were noted on a few electrodes. Troubleshooting, hardware exchange and reprogramming 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: Bruise/Contusion; Head Injury; Swelling/ Edema

  MAUDE report 50850138 ↗
• InjurySep 22, 2026Malposition of Device

  Per the clinic, the tip of the electrode array was found to be folded over in the cochlea, 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 50850137 ↗
• InjurySep 22, 2026Therapeutic or Diagnostic Output Failure

  Per the clinic, the implant was not functioning according to specifications. 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 50849891 ↗
• InjurySep 21, 2026Malposition of Device; Migration

  Per the clinic, several electrodes had migrated out of the cochlea after being accidentally pulled during incision closure in a previous revision surgery. An electrode reinsertion procedure was attempted on (b)(6) 2026; however, the tip of the electrode array was found to be folded over in the cochlea. Subsequently, the device was explanted, and the patient was re-implanted with another cochlear device during the same surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837314 ↗
• InjurySep 21, 2026Malposition of Device; Migration

  Per the clinic, several electrodes had migrated out of the cochlea after being accidentally pulled during incision closure in a previous revision surgery. An electrode reinsertion procedure was attempted on August 26, 2026; however, the tip of the electrode array was found to be folded over in the cochlea. Subsequently, 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 50837313 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was explanted on (b)(6), 2026 due to skin cancer near the implant area. The patient was not reimplanted.

  Patient problems: Cancer

  MAUDE report 50814574 ↗
• InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced an infection with swelling at implant site and subsequently, was treated with oral antibiotic for a duration of 12 days. However, the issue could not be resolved, and 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: Medical device site infection; Swelling/ Edema

  MAUDE report 50799602 ↗

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.