NIM Vital NIM4CM01RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000002992), received between Apr 1, 2024 and Sep 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K200759); 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.

Recalls naming this device

1. Mar 10, 2025Class IIOpen, Classified

   Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

   Z-1623-2025 · Root cause: Software change control · Recall details · FDA record ↗

2. Jun 24, 2024Class IOpen, Classified

   Potential for false negative response on the NIM Vital Nerve Monitoring System

   Z-2409-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that intra-op, the NIM Console had not stimulation properly, switched from brief tone to continuous, at first there was no stimulation response but when probe was removed and put back on the nerve it gave an overwhelming response. No patient impact or injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877735 ↗
• MalfunctionFeb 3, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING A CASE WHEN SURGEON WAS ATTEMPTING TO MONITOR, RECEIVED EXCESSIVE NOISE FROM THE SYSTEM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255123 ↗
• MalfunctionOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED, THE EVENT OCCURRED PRIOR TO USE. TROUBLESHOOTING DONE, REMOVED BATTERY AND POWERED BACK UP AND STILL BEEPING. REP REPORTED SWAPPING TO AN OUTLET BUT STILL IN THE HALLWAY AREA. ISSUE STILL NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345437 ↗
• MalfunctionJun 24, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT NIM VITAL WAS GIVING LOUD FEEDBACKS. ALSO THE BLUE POWER LIGHT TURNING YELLOW INSTEAD BLUE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22313135 ↗
• MalfunctionMay 16, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING TESTING, WHEN USING THE PROB TO DELIVERY ENERGY, NOTHING HAPPENS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036797 ↗
• MalfunctionFeb 3, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WERE UNUSUAL SIGNALS, LOOKING LIKE DIRECT STIMULATION OF THE MUSCLE, THAT ENABLED TO SEE THE REAL SIGNAL. THE HARDWARE SET-UP WAS VERIFIED BEFORE THE USE AND THE SURGEON OBSERVED THE WAVEFORM RESPONSE ON THE SCREEN. THE ACTIVITY OCCUR ONLY DURING THE STIMULATION. THERE WAS NO TONE WHEN USING ELECTROCAUTERY. AFTER CHANGING THE REJECTION PERIOD TO 3.5 MS, IT WAS A BIT BETTER BUT NOT COMPLETELY. THE SOFTWARE VERSION 1.6.4 WAS PRESENT DURING THE EVENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291458 ↗
• MalfunctionDec 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SYSTEM'S PATIENT INTERFACE HAS PHYSICAL DAMAGE AND  INTERMITTENT PAIRING CONNECTIVITY TO THE CONSOLE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815944 ↗
• MalfunctionApr 1, 2024False Negative Result; Inappropriate Audible Prompt/Feedback; False Negative Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PAROTID CASE, THE SURGEON HAD A NEGATIVE TONE (TWEEDLE) WHEN TOUCHING A NERVE. PHYSICIAN EXPECTED TO HEAR THE POSITIVE ¿BUMP BUMP BUMP¿ BIPHASIC WAVE SOUND INDICATING THE NERVE WAS BEING STIMULATED. INSTEAD, THE TWEEDLE INDICATING THAT THEY WERE NOT TOUCHING NERVE RESPONDED. PHYSICIAN WAS CONFIDENT HE WAS ON NERVE. OLDER PHYSICIAN THAT WAS TRAINED WITHOUT THE NIM AND VERY STRONG ANATOMY KNOWLEDGE. FELT STRONGLY THAT THE SYSTEM WAS INCORRECT. THE PROCEDURE WAS EXTENDED FOR LESS THAN 1 HOUR. THERE WAS NO PATIENT IMPACT. EVENT COULD NOT BE REPLICATED BY REP OR BIOMED. USED SUBSEQUENTLY WITH DIFFERENT PI BOX AND WORKED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200759. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2022 · May 3, 2022 · Open, Classified
  NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
• Z-1223-2022 · May 3, 2022 · Open, Classified
  NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2