NIM® 8229308Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169789548), received between Oct 19, 2018 and May 20, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K925640); 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.

Recalls naming this device

1. Apr 29, 2022Open, Classified

   The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

   Z-1520-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THE THYROID PROCEDURE, THE NIM 3.0 WAS MAKING EXCESSIVE NOISE. TROUBLESHOOTING WAS PERFORMED BY ADJUSTING THE BED CONTROLLER NEXT TO THE PATIENT INTERFACE, WIRES WRAPPED AROUND THE PATIENT INTERFACE, CHANGED AND WENT TO A SECOND NIM SYSTEM BUT THE PROBLEM PERSISTED. THE SOUND OF THE NIM WAS IN A PATTERN AT THAT TIME AND IT WAS IMPOSSIBLE TO GET RID OF THE NOISE ON THE NIM. IT WAS REALIZED THAT EVERY TIME THE PATIENT EXHALED ON THE ANESTHESIA VENTILATOR, THE NOISE WOULD HAPPEN ON THE NIM. AT THAT TIME, IT WAS REALIZED THAT THE CONTACT EMG TUBE WAS OLD WHICH HAD EXPIRED. NORMAL MONITORING SEEMED TO BE CONTINUED WITH NO ISSUES EVEN IF THERE WAS NOISE, STIM WAS MOVED TO 2.0 MV TO TRIGGER A RESPONSE. THE ELECTROSURGICAL EQUIPMENT AND MUTING WAS IN USE DURING THE PROCEDURE. WHEN STIM PROBE WAS USED A BIPHASIC WAVEFORM WAS PRESENT. THE PROCEDURE WAS EXTENDED BY 30 MINUTES AND WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050106 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 21559991 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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; Unintended Extubation

  MAUDE report 21559730 ↗
• MalfunctionMar 5, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRIOR TO USE, CUFF WAS STICKING TO THE TUBE. NEW TUBE WAS OPENED AND USED. THERE IS NO PATIENT INVOLVED IN THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18834522 ↗
• MalfunctionOct 16, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT PRE-OP, THE ANESTHESIA TEAM EXPERIENCED A PROBLEM WITH THIS PRODUCT. THERE WAS A LEAK IN THE VALVE. THE BALLOON DID NOT HOLD PRESSURE AND DEFLATED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17937695 ↗
• MalfunctionMar 23, 2023Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT THE CUFF AND TUBE CHECKED PRIOR TO USE TO ENSURE PROPER FUNCTIONALITY, TUBE WAS EXTUBATED AND REINTUBATION. THE OBSTRUCTION CAUSE THE USER TO BE UNABLE TO ESTABLISH THE AIRWAY DURING THE INTUBATION PROCESS. THE LOSS OF ETCO2 OCCURRED JUST PRIOR TO BEING UNABLE TO VENTILATE, THE PATIENT AND/OR TUBE REPOSITIONED, AND THE CUFF OF THE TUBE DEFLATED PRIOR TO REPOSITIONING, THEN RE-INFLATED ONCE THE PATIENT/TUBE WAS SETTLED. THE INTRACUFF PRESSURE WAS NOT MONITORED. AS PER CT SCAN OF NECK THERE WAS NO ANY DIFFICULTIES, SUCH AS UNEXPECTED ANATOMY OR DIFFICULT INTUBATION, NOTED THAT MAY HAVE AFFECTED THE USE OF THE DEVICE. AIR WAS USED TO INFLATE THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 16598655 ↗
• 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 16111605 ↗
• InjuryMay 19, 2022Partial Blockage; Use of Device Problem; Improper or Incorrect Procedure or Method; Partial Blockage; Use of Device Problem; Improper or Incorrect Procedure or Method

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE EXTERNAL BULB OF ENDOTRACHEAL TUBE THAT WOULD NORMALLY INDICATE CUFF INFLATION FAILED AND THIS CAUSED MORE AIR TO BE PLACED INTO THE CUFF. THE CUFF WAS SO COMPLIANT THAT IT OVERINFLATED AND OBSTRUCTED THE ETT CAUSING A FAILED VENTILATION SITUATION. THE PATIENT DESATURATED AND WE WERE NOT ABLE TO VENTILATE. THEY ENDED UP HAVING TO REMOVE THE NIMS TUBE AND REPLACING IT WITH A TRADITIONAL ETT. THE PATIENT DID WELL AT THAT POINT. THE PROBLEM THEY ENCOUNTERED WAS TWOFOLD. FIRST THE CUFF ON THE NIMS TUBE IS TOO COMPLIANT AND CAN EASILY BE OVERINFLATED AND HERNIATE FORWARD TO OCCLUDE THE TUBE OPENINGS. SECOND, THE PILOT BULB IS TOO STIFF AND DOES NOT INFLATE APPROPRIATELY TO INDICATE CUFF INFLATION. THIS IS A SERIOUS PATIENT CARE ISSUE THAT COULD HAVE RESULTED IN PATIENT HARM OR DEATH. ON FOLLOW-UP, IT WAS REPORTED THAT THE ISSUE WAS NOT EVIDENT PRIOR TO INTUBATION; THE CUFF WAS BRIEFLY INFLATED WITH 10ML AIR TO CONFIRM CUFF INFLATION. THE EVENT OCCURRED DURING A C5-C6 ARTHROPLASTY. THERE WAS A SURGICAL DELAY FOR ABOUT 30 MINUTES AS THEY HAD TO TROUBLE SHOOT FAILED VENTILATION THROUGH THE NIMS TUBE. THE PATIENT SUFFERED NO LONG TERM CONSEQ

  Patient problems: Airway Obstruction; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 14438523 ↗
• MalfunctionFeb 1, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT ONE OF THE WIRES WERE COMING OFF THE TUBE AND WAS NOTICED DURING INTUBATION DURING A TOTAL W/ CENTRAL NECK DISSECTION PROCEDURE. IT WAS REPLACED WITH A DIFFERENT TUBE. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE TUBE WAS INTUBATED AND EXTUBATED AFTER NOTICING THE ISSUE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. A BACK-UP DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 13411288 ↗
• InjuryMar 26, 2021Deflation Problem; Use of Device Problem; Obstruction of Flow; Deformation Due to Compressive Stress; Deflation Problem; Use of Device Problem; Obstruction of Flow; Deformation Due to Compressive Stress

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE CUFF ON THE TUBE ITSELF HERNIATED OVER THE MURPHYS EYE ON THE TUBE, SUBSEQUENTLY PUSHING THE END OF THE TUBE ONTO THE TRACHEA RESULTING IN A COMPLETE OCCLUSION AND BEING UNABLE TO VENTILATE OUR PATIENT AFTER SEVERAL REINSERTIONS. THIS WAS VISIBLE WITH THE USE OF A FIBRE-OPTIC SCOPE DOWN THE TUBE. ALSO, THE PILOT CUFF ON THE TUBE DOESN'T PRESSURIZE WITH THE CUFF ITSELF. THIS SEEMED TO BE FAIRLY INCONSISTENT. ON FOLLOW UP, IT WAS STATED THAT THERE WERE 2 EMG TUBES USED IN THIS EVENT. THE FIRST COULD HAVE BEEN OVER INFLATED, THE SECOND WAS NOT, THE HCP WAS CONFIDENT LESS THAN 20ML USED BUT CANNOT BE CERTAIN. AFTER INFLATING THE CUFF, THE PATIENT OR TUBE WAS NOT RE-POSITIONED. WHEN THE HERNIATION WAS SEEN, AIR WAS REMOVED FROM THE CUFF TO ALLOW IT TO RETURN TO ITS NORMAL POSITION AND THEN REINFLATED TO SECURE IN THE PATIENT¿S AIRWAY BUT TUBE POSITION DID NOT ALTER SIGNIFICANTLY. BECAUSE OF EXPERIENCE AND AGILITY OF TEAM OBSTRUCTION WAS DIAGNOSED QUICKLY, PREVENTING LIFE THREATENING INJURY. REPEATED REINTUBATION WAS PERFORMED WHICH MAY HAVE CAUSED DIRECT LARYNGEAL TRAUMA. THE EMG TUBES COULD NOT BE USED DUE TO THIS

  Patient problems: Airway Obstruction; Obstruction/Occlusion; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 11574350 ↗
• InjuryMar 26, 2021Deflation Problem; Use of Device Problem; Obstruction of Flow; Deformation Due to Compressive Stress; Deflation Problem; Use of Device Problem; Obstruction of Flow; Deformation Due to Compressive Stress

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE CUFF ON THE TUBE ITSELF HERNIATED OVER THE MURPHYS EYE ON THE TUBE, SUBSEQUENTLY PUSHING THE END OF THE TUBE ONTO THE TRACHEA RESULTING IN A COMPLETE OCCLUSION AND BEING UNABLE TO VENTILATE OUR PATIENT AFTER SEVERAL REINSERTIONS. THIS WAS VISIBLE WITH THE USE OF A FIBRE-OPTIC SCOPE DOWN THE TUBE. ALSO, THE PILOT CUFF ON THE TUBE DOESN'T PRESSURIZE WITH THE CUFF ITSELF. THIS SEEMED TO BE FAIRLY INCONSISTENT. ON FOLLOW UP, IT WAS STATED THAT THERE WERE 2 EMG TUBES USED IN THIS EVENT. THE FIRST COULD HAVE BEEN OVER INFLATED, THE SECOND WAS NOT, THE HCP WAS CONFIDENT LESS THAN 20ML USED BUT CANNOT BE CERTAIN. AFTER INFLATING THE CUFF, THE PATIENT OR TUBE WAS NOT RE-POSITIONED. WHEN THE HERNIATION WAS SEEN, AIR WAS REMOVED FROM THE CUFF TO ALLOW IT TO RETURN TO ITS NORMAL POSITION AND THEN REINFLATED TO SECURE IN THE PATIENT¿S AIRWAY BUT TUBE POSITION DID NOT ALTER SIGNIFICANTLY. BECAUSE OF EXPERIENCE AND AGILITY OF TEAM OBSTRUCTION WAS DIAGNOSED QUICKLY, PREVENTING LIFE THREATENING INJURY. REPEATED REINTUBATION WAS PERFORMED WHICH MAY HAVE CAUSED DIRECT LARYNGEAL TRAUMA. THE EMG TUBES COULD NOT BE USED DUE TO THIS

  Patient problems: Airway Obstruction; Obstruction/Occlusion; Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 11574326 ↗
• MalfunctionJan 11, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DEVICE'S WIRE WERE EXPOSED. UPON FOLLOW UP IT WAS STATED THAT THE EVENT OCCURRED JUST BEFORE SURGERY BEGAN. THERE IS NO RECORD OF IMPACT WITH PATIENT OR STAFF. THERE WAS A BRIEF DELAY IN THE BEGINNING OF THE SURGERY BECAUSE ANOTHER TUBE HAD TO BE OBTAINED IN ORDER TO BEGIN. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146702 ↗
• MalfunctionOct 19, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE DEVICE DID NOT WORK WHEN THEY WENT TO USE IT DURING THYROIDECTOMY. THERE WAS A PROBLEM WITH THE TUBE AND MONITOR NOT SYNCHING TOGETHER. ONCE THE TUBE WAS CHANGED, THE MONITOR WORKED FINE. THEY HAD TO OPEN A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7983605 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K925640. One submission often covers many models, so check the product and lot details in each record.

• Z-0901-2017 · Jun 28, 2016 · Terminated
  NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
• Z-0310-05 · Oct 29, 2004 · Terminated
  Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-