N/A 8228052Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000034085), received between Apr 5, 2024 and Aug 5, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

3 other recalls cover devices cleared under the same FDA submission (K083124); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT PACKAGE. A NEW UNIT OF APS ELECTRODE WAS OPENED. ONCE THE SURGEON ATTACHED THE APS TO THE VAGUS, THERE WAS NO BASELINE READING AS THE MACHINE COULDN¿T DETECT THE ELECTRODE. CHECKED THE APS AND THERE WAS NO VISIBLE ELECTRODE IN APS CLIP. SURGEON OPEN NEW APS AND EVERYTHING WORKED FINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711180 ↗
• MalfunctionJul 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, APS ELECTRODE WAS NOT IN CORRECT LOCATION. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403735 ↗
• MalfunctionMay 30, 2025Break; Incorrect, Inadequate or Imprecise Result or Readings; Break; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING NECK TUMOR REMOVAL SURGERY, AFTER ATTACHING THE APS ELECTRODE TO THE VAGUS NERVE WHILE ATTEMPTING TO TAKE A BASELINE THE LEAD-OFF DISPLAY APPEARED, AND STIMULATION WAS NOT POSSIBLE. WHEN CHECKING THE APS ELECTRODE, FOUND THAT THE ELECTRODE PART WAS NOT EXPOSED AND HAD COME OUT. A SPARE NEW PRODUCT WAS OPENED AND USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112739 ↗
• MalfunctionNov 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID SURGERY WITH APS 2MM, THE FIRST APS HAD SIGNAL LOST. CHANGED TO ANOTHER 2MM APS BUT THERE WAS NO VISIBLE METAL ELECTRODE. CHANGED TO 3MM AND IT WAS WORKING FINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708263 ↗
• MalfunctionOct 25, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT INTRA-OP, THE APS ELECTRODE WAS WORKING WELL FOR THE FIRST HALF OF THE SURGERY BUT THEN HAD A LOSS OF SIGNAL. CHANGED THE APS ELECTRODE AND IT WORKED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20530775 ↗
• MalfunctionSep 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Difficult to Open or Close; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THYROID SURGERY, THE CUSTOMER PLACED THE ELECTRODE OVER THE VAGUS NERVE, BUT IT DID NOT STIMULATE. SO THE CUSTOMER REMOVED THE ELECTRODE, INSPECTED IT AND REALIZED, THAT THE METAL PIN FOR GETTING IN CONTACT WITH THE VAGUS NERVE WAS NOT EXISTENT. SO IT WAS NOT POSSIBLE TO USE THIS ELECTRODE AND A NEW ONE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116586 ↗
• MalfunctionJul 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INTRA-OPERATIVE ELECTRODES PLACED ON THE NERVE BUT THERE WERE NO STIMULATION. THE STIM RETURNED DID NOT SHOW 0 AND THE USER CONFIRMED THAT NOTHING CAUSED A LACK OF RESPONSE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768511 ↗
• MalfunctionMay 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE THYROIDECTOMY PROCEDURE, THE ELECTRODE WAS PLACED IN PATIENT, NO SIGNAL COULD BE OBTAINED, I.E. THE NERVE WAS NOT STIMULATED. THERE WAS A LONGER DURATION OF THE SURGERY AND TIMELY INTERVENTION WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH A ANOTHER ELECTRODE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391875 ↗
• MalfunctionMay 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DRING PROCEDURE, THE APS ELECTRODE WAS PLACED ON PATIENT NERVE BUT THERE WAS NO STIMULATION. PROCEDURE WAS COMPLETED WITH BACK UP PRODUCT. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352337 ↗
• MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECIEVED AFTER FOLLOW UP THAT THE STIM RETURNED DID NOT SHOW 0 AND THE USER CONFIRMED THAT NOTHING CAUSED A LACK OF RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049152 ↗
• MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECIEVED AFTER FOLLOW UP THAT THE STIM RETURNED DID NOT SHOW 0 AND THE USER CONFIRMED THAT NOTHING CAUSED A LACK OF RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049097 ↗
• MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT THE STIM RETURNED DID NOT SHOW 0 AND THE USER CONFIRMED THAT NOTHING CAUSED A LACK OF RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048940 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083124. One submission often covers many models, so check the product and lot details in each record.

• Z-2343-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patie
• Z-2342-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient
• Z-2344-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patie