Cochlear® Nucleus® CI512 cochlear ImplantRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,771 adverse event reports that list this exact device (DI 09321502014564), received between Jan 7, 2013 and Sep 29, 2026 — classified as 2,075 injuries, 695 malfunctions.

The most frequently reported specific device problem is “No Device Output” (487 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,771 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Read Input Signal; Intermittent Shock/Stimulation

  Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Hardware exchange 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 50927650 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Correction: The correct product is CP1000 Magnet (6M,Brown), not Nucleus CI512 Cochlear Implant with Contour Advance Electrode as previously reported.

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

  MAUDE report 50894390 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Per the clinic, the patient underwent a skin flap reduction surgery (specific date not reported) due to thick skin which resulted in the issue of maintaining connection with the processor coil, despite increasing to the strongest magnet strength and attempting multiple retention options. The implanted device remains.

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

  MAUDE report 50894388 ↗
• MalfunctionSep 22, 2026Failure to Deliver Shock/Stimulation; Loose or Intermittent Connection; Failure to Read Input Signal; Intermittent Shock/Stimulation; Output Problem

  Per the clinic, the patient experienced intermittencies while driving over cobblestones with car and subsequent loss of hearing and loss of connection to the internal device. Troubleshooting attempts were made; however, the issue could not be resolved. It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.

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

  MAUDE report 50851006 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated; Device Handling Problem

  Per the clinic, the patient experienced edema and magnet dislodgement during an MRI (1.5 Tesla); However, the clinician did not follow the manufacturer's instructions for use of MRI. Subsequently, a revision surgery on (b)(6) 2026, is done to reposition the existing magnet into place and the implanted device remains.

  Patient problems: Swelling/ Edema

  MAUDE report 50835355 ↗
• InjurySep 19, 2026Failure to Deliver Shock/Stimulation; Therapy Delivered to Incorrect Body Area

  Patient problems: Twitching; Undesired Nerve Stimulation

  MAUDE report 50832640 ↗
• InjurySep 19, 2026Failure to Deliver Shock/Stimulation; Therapy Delivered to Incorrect Body Area

  Patient problems: Twitching; Undesired Nerve Stimulation

  MAUDE report 50832639 ↗
• MalfunctionSep 18, 2026Failure to Read Input Signal

  Per the clinic, the patient experienced a loss of connection to the internal device (specific date not reported). Troubleshooting and hardware exchange 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 50813548 ↗
• MalfunctionSep 18, 2026Failure to Read Input Signal

  Per the clinic, the patient experienced a loss of connection to the internal device (specific date not reported). Troubleshooting and hardware exchange 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 50813547 ↗
• InjurySep 17, 2026Biofilm coating in Device

  Per the clinic, the patient experienced recurrent swelling, pain and infection at the implant site and was treated with antibiotics (specific type, date and duration not reported); however, the issue could not be resolved. The swelling around the implant reported to be consistent with infection or inflammation and most likely related to the formation of a biofilm. 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: Implant Pain; Inflammation; Medical device site infection; Swelling/ Edema

  MAUDE report 50804218 ↗
• InjurySep 9, 2026Circuit Failure; Unexpected Therapeutic Results

  Per the clinic, the patient experienced poor performance with the device and open circuits were noted on EC1 electrodes. Re-programming 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 50683006 ↗
• InjurySep 9, 2026Circuit Failure; Unexpected Therapeutic Results

  Per the clinic, the patient experienced poor performance with the device and open circuits were noted on EC1 electrodes. Re-programming 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 50683005 ↗
• InjurySep 9, 2026Therapy Delivered to Incorrect Body Area

  Per the clinic, the device was explanted on (b)(6) 2026 due to facial nerve stimulation. The patient was re-implanted with another device during the same surgery.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50682761 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Per the clinic, the device was electively explanted as per the patient's request on (b)(6) 2025. The patient was reimplanted with another cochlear device during the same surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449823 ↗
• InjuryAug 24, 2026Failure to Deliver Shock/Stimulation; Unexpected Therapeutic Results; Expulsion

  Per the clinic, the patient had occluding earwax in the ear canal and was seen for earwax removal. During the procedure, an extrusion of the electrode array into the ear canal was discovered. The patient reportedly experienced sounds like rushing water and subsequently lost all sound perception from the implanted device. The device was explanted on (b)(6) 2026, and the patient was reimplanted with a new device during the same surgery.

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

  MAUDE report 50399729 ↗
• InjuryAug 24, 2026Failure to Deliver Shock/Stimulation; Unexpected Therapeutic Results; Expulsion

  Per the clinic, the patient had occluding earwax in the ear canal and was seen for earwax removal. During the procedure, an extrusion of the electrode array into the ear canal was discovered. The patient reportedly experienced sounds like rushing water and subsequently lost all sound perception from the implanted device. The device was explanted on (b)(6) 2026, and the patient was reimplanted with a new device during the same surgery.

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

  MAUDE report 50399728 ↗
• InjuryAug 18, 2026Failure to Deliver Shock/Stimulation

  Per the clinic, the patient became a non-user as the patient not receiving benefit from the implant since activation. The patient also experienced pain during an MRI procedure despite the use of a head wrap. Reprogramming attempts were made; however the issue could not be resolved. Subsequently, the device was electively explanted on (b)(6) 2026. The patient was reimplanted with another device on the contralateral ear during the same surgery.

  Patient problems: Pain

  MAUDE report 50295679 ↗
• MalfunctionJul 27, 2026Failure to Deliver Shock/Stimulation; Failure to Read Input Signal

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

  MAUDE report 50011514 ↗
• MalfunctionJul 27, 2026Failure to Deliver Shock/Stimulation; Failure to Read Input Signal

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

  MAUDE report 50011513 ↗
• InjuryJul 27, 2026Failure to Deliver Shock/Stimulation; Loose or Intermittent Connection; Failure to Read Input Signal

  Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Hardware exchanges and reprogramming attempts were made; however, the issue could not be resolved. 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 50002998 ↗
• InjuryJul 27, 2026Failure to Deliver Shock/Stimulation; Loose or Intermittent Connection; Failure to Read Input Signal

  Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Hardware exchanges and reprogramming attempts were made; however, the issue could not be resolved. 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 50002997 ↗
• InjuryJun 25, 2026Insufficient Device Problem Information

  PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) DUE TO UNKNOWN REASON. 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: Insufficient Information

  MAUDE report 25618428 ↗
• InjuryJun 22, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED MIDDLE EAR INFLAMMATION AND DURING THE EXAMINATION AND MEDICAL PROCEDURES, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Inflammation

  MAUDE report 25573800 ↗
• MalfunctionJun 16, 2026Failure to Deliver Shock/Stimulation; Loose or Intermittent Connection; Intermittent Shock/Stimulation

  PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES, NO SOUND AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. 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: Failure of Implant

  MAUDE report 25513926 ↗
• InjuryJun 14, 2026Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE MAGNET SITE WHICH STARTED AFTER MAGNET REPALCEMENT SURGERY FOR MRI IN (B)(6) 2022. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED FOR TREATMENT WITH IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Medical device site infection

  MAUDE report 25497825 ↗

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.