NIM-Response® 8253001RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169871014), received between Dec 8, 2017 and Feb 3, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026False Negative Result

  IT WAS REPORTED THAT THE DEVICE HAD PRASS PROBE IS NOT PRODUCING A SIGNAL. TROUBLESHOOTING WAS PERFORMED UPDATED FROM TECH SERVICE READ INSTRUCTIONS FOR USE TO BIOMED AND SENT MANUALS TO BIOMED. SYSTEM IS CURRENTLY IN USE SO TROUBLESHOOTING COULD NOT OCCUR DURING CALL. BIOMED ALSO ASKED ABOUT SOFTWARE UPDATES BUT TECH SERVICE DID NOT HAVE VISIBILITY ON SOFTWARE. TECH SERVICE INFORMED BIOMED THAT CURRENT AND RESPONSE THRESHOLD SETTINGS COULD BE ADJUSTED IF NEEDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255168 ↗
• MalfunctionFeb 3, 2026False Negative Result

  IT WAS REPORTED THAT DURING THE INTRAOPERATIVE, THE SURGEON WAS INITIALLY UNABLE TO GENERATE A STIMULATION RESPONSE WITH NIM VITAL ((B)(6)) FROM ELECTRODE 1 OR 2, EVEN THOUGH THE ELECTRODE INTEGRITY CHECK PASSED. THE CLINICAL STAFF THEN SWITCHED TO A MEDTRONIC NIM RESPONSE 3.0 (S/N (B)(6)), BUT NO STIMULATION RESPONSE WAS OBTAINED WITH THAT UNIT EITHER. CHANGING THE PROBES DID NOT IMPROVE THE SITUATION. THE SURGEON DETERMINED THAT THE ELECTRODES WERE NOT PLACED ON THE TRUNK OF THE NERVE, WHICH IS WHY NO MUSCLE RESPONSE WAS ELICITED. DESPITE THE LACK OF STIMULATION RESPONSE, THE PROCEDURE WAS COMPLETED SAFELY BASED ON THE SURGEON¿S CLINICAL KNOWLEDGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244235 ↗
• MalfunctionAug 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT WHILE IN SURGERY, THE SYSTEM WAS GIVING NO RESPONSE WHEN THE SURGEON USED THE STIM PROBE. THE SYSTEM PASSED ELECTRODE CHECK. PLUGGED A PATIENT SIMULATOR INTO THE SYSTEM AND CONFIRMED THAT ALL CHANNELS WERE GIVING A RESPONSE. BIOMED RECOMMENDED TO SURGEON TO SWAP OUT PROBES. HOWEVER, ANOTHER HOUR INTO THE CASE, THE SURGEON CALLED THE BIOMED TO INFORM THAT THE SYSTEM WAS STILL GIVING NO RESPONSE ON ANY CHANNELS. TROUBLSEHOOTING WAS PERFORMED HOWEVER THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808258 ↗
• MalfunctionMar 10, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE IN THYROID MASS SURGERY, THE SITE WAS NOT RECEIVING ANY RESPONSE FROM THE EMG TUBE. REP FACETIMED THE SITE AND SAW THAT WHEN THUMPING THE NECK TO GET MECHANICAL RESPONSE, THE WAVEFORM WAS FLAT. THE ELECTRODE CHECK SHOWED NO ISSUES. THE SITE HAD TRIED INCREASING THE STIM AND DECREASING THE THRESHOLD WITH NO RESOLUTION. SWAPPED EMG TUBE WITH NO CHANGE. UNABLE TO STIMULATE THE NERVE, HOWEVER WAS ABLE TO GET A STIM RESPONSE WITH PROBE, CONFIRMING THE PROBE WAS WORKING. DOCTOR WAS CONCERNED FOR THE PRESERVATION OF THE NERVE, THE NIM GAVE NO NERVE RESPONSE TONE DURING CASE. REP SHOWED UP AT THE END OF THE PROCEDURE AND TRIED A SECOND PATIENT BOX. THERE WAS NO CHANGE IN OUTCOME OF RESPONSE. THERE WAS A SURGICAL DELAY OF MORE THAN AN HOUR. THYROID WAS CLOSED AND PATIENT MOVED TO PACU. THEY USED THE PRASS PROBE TO STIMULATE THE NERVE. THE PROCEDURE WAS COMPLETED WITH NIM, WITHOUT NIM/NERVE CONFIRMATION. NO THERAPY WAS GIVEN IN PACU, PATIENT WAS ABLE TO SPEAK AND SWALLOW AS PER DOCTOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559419 ↗
• MalfunctionFeb 12, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PROCEDURE, THE OUTPUT AUDIO FROM THE NIM WAS NOT NORMAL. SOUND WAS SCRATCHY AND HAD A LOT OF STATIC, WE CHECKED AROUND THE OR AND COULDN¿T FIND A SOURCE OF INTERFERENCE. WE SWAPPED THE MUTE CABLE, NO CHANGE. WE THEN SWAPPED INTERFACE MODULE, STILL NO CHANGE. FINALLY SWAPPED THE NIM MONITOR OUT FOR A DIFFERENT NIM AND THE SOUND WAS NORMAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362307 ↗
• MalfunctionSep 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING FESS PROCEDURE, PRIOR TO INCISION BUT AFTER INTUBATION, STEMMED THE PATIENT'S NECK AND GOT A NORMAL RESPONSE. DURING THE PROCEDURE, A TRIVANTAGE TUBE WAS UTILIZED. HOWEVER, WHEN THE SURGEON ATTEMPTED STIMULATION, THE MACHINE MADE A TWEEDLE NOISE, INDICATING NO STIM. STIMMED THE VAGUS NERVE INSIDE THE CAROTID SHEATH WITH 3 MILLIAMPS AND GOT NO VISUAL MOVEMENT IN THE MUSCLE. PROCEDURE WAS EXTENDED BY LESS THAN A HOUR AND ABORTED THE CASE ON THE CONTRALATERAL SIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338292 ↗
• MalfunctionSep 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, PRIOR TO INCISION BUT AFTER INTUBATION, THE SURGEON STIMMED THE PATIENTS NECK AND GOT A NORMAL RESPONSE. DURING THE PROCEDURE, A TRIVANTAGE 2 WAS UTILIZED. HOWEVER, WHEN THE SURGEON ATTEMPTED STIMULATION, THE MACHINE MADE A TWEEDLED NOISE, INDICATING NO STIM. SURGEON STIMMED THE VAGUS NERVE INSIDE THE CAROTID SHEATH WITH 3 MILLIAMPS AND GOT NO VISUAL MOVEMENT IN THE MUSCLE. THERE WAS AROUND 1 HOUR DELAY IN THE PROCEDURE. THE SURGERY WAS ABORTED ON THE CONTRALATERAL SIDE. THE TUBE WAS WORKING PROPERLY DURING PRE-OP. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330962 ↗
• MalfunctionAug 6, 2024Inappropriate Audible Prompt/Feedback; Device Misassembled During Manufacturing /Shipping; Application Program Freezes or Fails to Launch; Inappropriate Audible Prompt/Feedback; Device Misassembled During Manufacturing /Shipping; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING ELECTRODE AND PROBE PLACEMENT PROCEDURE, NIM SYSTEM BECAME UNRESPONSIVE, FREEZING AND MADE EXCESSIVE NOISE. PROCEDURE WAS COMPLETED WITH REPORTED PRODUCTS. THERE WAS NO PATIENT INJURY OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916437 ↗
• MalfunctionJul 25, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DURING PRE-OP, NIM MAINFRAME WAS SHOWING ERROR, CANNOT FIND THE REQUIRED MAP NAME. ONCE THE UNIT WAS LEFT ON THE ERROR MESSAGE PAGE AND THE UNIT WAS WARMED UP, IT WILL BOOT UP PROPERLY. THE ERROR POPULATES AT BOOT UP WHEN NOT ALREADY WARMED UP. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THE BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834501 ↗
• MalfunctionApr 23, 2024Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE ISSUE WITH THE MAINFRAME WAS WHEN THEY TURN IT ON, THE ENTIRE SCREEN TURN COMPLETELY WHITE AND COMPLETELY FREEZES. ATTEMPTED TO TURN IT ON AND OFF, TRIED DIFFERENT OUTLETS AND GOT THE SAME ISSUE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161402 ↗
• MalfunctionNov 14, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED DURING THYROIDECTOMY PROCEDURE THAT THE DEVICE HAD NOT WORKING. PATIENT INTERFACE EMG TEST STAYS WITH QUESTION'S MARKS. THERE WAS NO PATIENT INVOLVED. CUSTOMER CONFIRMS MACHINE IS WORKING JUST FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130255 ↗
• MalfunctionNov 7, 2023Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING TESTING, THE MAINFRAME AUDIO OUTPUT DOES NOT SOUND NORMAL. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081468 ↗
• MalfunctionJan 6, 2023Device Sensing Problem; Device Sensing Problem

  THE SURGEON REPORTED THAT ONCE THE PATIENT WAS POSITIONED WITH A SHOULDER ROLL DURING A THYROIDECTOMY, LARYNGOSCOPY WAS USED TO CONFIRM THAT THE ENDOTRACHEAL TUBE WAS POSITIONED CORRECTLY. AN ELECTRODE CHECK WAS PERFORMED ON THE NIM MONITOR; AT FIRST, VOCALIS 1 HAD A RED X, BUT THEN IT TURNED TO A GREEN CHECK MARK. EVERYTHING ELSE HAD GREEN CHECKMARKS, AND ALL OF THE IMPEDANCES WERE WITHIN NORMAL LIMITS. THE RIGHT RECURRENT LARYNGEAL NERVE (RLN) WAS ENCASED IN AN AGGRESSIVE TUMOR; THE DIFFICULT DISSECTION MAY HAVE CAUSED NEUROPRAXIA, AND THAT IS WHY THE RIGHT RLN NEVER RESPONDED TO STIMULATION. THAT NERVE WAS SACRIFICED DUE TO THE LARGE, INVASIVE CANCER ON THAT SIDE. THE LEFT THYROID LOBE AND LEFT RECURRENT LARYNGEAL NERVE APPEARED NORMAL, AND THE DISSECTION WAS ROUTINE; HOWEVER, THE LEFT RECURRENT LARYNGEAL NERVE NEVER STIMULATED (RESPONDED) AT ANY POINT DURING THE CASE, EVEN THOUGH THE NIM SYSTEM WAS PROVIDING THE EXPECTED AUDIBLE FEEDBACK THAT INDICATED THAT STIMULUS WAS BEING DELIVERED. NO ERROR MESSAGE DISPLAYED ON MONITOR AT ANY TIME. THE STIMULUS WAS DELIVERED USING A RANGE OF 0.8 TO 1.2 MA, AND THE THRESHOLD WAS SET TO THE DEFAULT SETTING. AT THE COMPLETION OF THE CASE, ANO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111663 ↗
• MalfunctionNov 30, 2020Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  ADDITIONAL INFORMATION INDICATED THAT THE MAINFRAME WAS NOT PICKING UP ANY SIGNAL AND HAS GONE THROUGH TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10919022 ↗
• MalfunctionSep 6, 2019Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT NERVE MONITORING DEVICES WERE NOT STIMULATING DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8968849 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT WHEN THE SURGEON PLACED THE ELECTRODES IN THE MOUTH DURING A NEUROSTIMULATOR (INSPIRA) IMPLANTED PROCEDURE, THE BLUE LEAD DID NOT FUNCTION PROPERLY. THE BLUE LEAD WAS REMOVED. THE PATIENT SUSTAINED A MINOR BURN TO THE FLOOR OF THE MOUTH ON THE LEFT SIDE. THE BLUE LEAD WAS REPLACED AND THE SURGERY WAS PROCEEDED WITH NO FURTHER COMPLICATIONS. THE SURGEON DID NOT RECOMMEND ANY ADDITIONAL TREATMENTS.

  Patient problems: Burn(s)

  MAUDE report 8702135 ↗
• MalfunctionMar 7, 2019Device Sensing Problem; Device Sensing Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS NOT PICKING OR WORKING PROPERLY WHEN CLOSE TO A NERVE DURING A PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400124 ↗
• MalfunctionFeb 15, 2019Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICES WERE NOT SENSING NERVE.THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344386 ↗
• MalfunctionNov 21, 2018Use of Device Problem; Audible Prompt/Feedback Problem; Use of Device Problem; Audible Prompt/Feedback Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE MAINFRAME AND PATIENT INTERFACE HAD AN INTERFERENCE/INCREASED FEEDBACK DURING MONITORING AND WERE NOT FUNCTIONING PROPERLY DURING THE PROCEDURE. THE SURGEON DID NOT WANT TO TROUBLESHOOT TO RESOLVE THE FEEDBACK SINCE THE PROCEDURE WAS ALMOST FINISHED, INSTEAD THE SURGEON REQUESTED TO SWAP OUT THE DEVICES WHICH WOULD BE QUICKER THAN TRYING TO TROUBLESHOOT THE DEVICE ISSUE. THE HCP NOTED THAT THE CONTINUOUS FEEDBACK SOUND WAS MORE ANNOYING TO THE SURGEON THAN A PROBLEM WITH THE MONITORING. THERE WAS JUST A SHORT DELAY IN THE PROCEDURE WHILE SWAPPING OUT THE DEVICES. THE CASE WAS COMPLETED WITH NEW SYSTEM DEVICES (MAINFRAME AND PATIENT INTERFACE). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096406 ↗
• MalfunctionNov 5, 2018Computer Software Problem; Intermittent Continuity; Use of Device Problem; Computer Software Problem; Intermittent Continuity; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE MAINFRAME HAS SCREEN DISPLAY ISSUE AND WORKED INTERMITTENTLY. THE TOUCHSCREEN WAS FREEZING DURING BOOT-UP AND NERVE MONITORING DEVICE CRASHES DURING SURGERY. THIS HAS HAPPENED MULTIPLE TIMES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039383 ↗
• MalfunctionOct 11, 2018False Positive Result; False Positive Result

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING THE PAROTIDECTOMY THE MAINFRAME HAD AN EXCESSIVE ARTIFACT EVEN WHEN THE PROBE WAS NOT CLOSE TO THE NERVE MONITORING TUBE. FOR TROUBLESHOOTING, THE HCP TRIED TO TURN IT OFF AND ON TO RESET HOWEVER, THE SAME ISSUE OCCURRED. THERE WAS A SURGICAL DELAY AS THE HCP NEEDED TO STOP AND GET A HAND HELD NERVE STIMULATOR TO COMPLETE THE CASE AFTER TRYING TO TROUBLE SHOOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7956433 ↗
• MalfunctionOct 11, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICES WAS NOT WORKING PROPERLY DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7956210 ↗
• MalfunctionFeb 13, 2018Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THAT THE NIM SYSTEM WAS INTERMITTENTLY NOT WORKING. THE CASE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT. THIS IS REGULATORY REPORT 1 OF 2 (NIM MAINFRAME).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266026 ↗
• MalfunctionDec 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED DURING TESTING THE DEVICE IS NOT READING ESOPHAGEAL STIMULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100415 ↗

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-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-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-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