NIMRecalls & reported problems across all models
Medtronic Xomed, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one NIM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 410
- Deaths reported
- 1
- Injuries reported
- 94
- Recalls
- 2
We found 15 models of NIM by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 410 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2017 and Sep 11, 2026 — classified as 1 death, 94 injuries, 315 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (185 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NIM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 9 of these models · Recall details · FDA record ↗
- 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-1519-2022 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
Most reported NIM problems
Device problems
- Unintended Deflation185
- Incorrect, Inadequate or Imprecise Result or Readings54
- Leak/Splash34
- Obstruction of Flow31
- Use of Device Problem18
- Material Protrusion/Extrusion15
- Break14
- Failure to Unfold or Unwrap12
Patient problems
- No Clinical Signs, Symptoms or Conditions315
- Unintended Extubation120
- Airway Obstruction33
- Low Oxygen Saturation24
- No Consequences Or Impact To Patient20
- Extubate9
- Hypoventilation6
- Obstruction/Occlusion5
NIM models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIM® 8229306STIMULATOR, NERVE1 recall1 death167 reports
- NIM® 8229307STIMULATOR, NERVE1 recall138 reports
- NIM 8229306STIMULATOR, NERVE1 recall29 reports
- NIM® 8229308STIMULATOR, NERVE1 recall13 reports
- NIM 8229307STIMULATOR, NERVE1 recall11 reports
- NIM 8229307STIMULATOR, NERVE1 recall7 reports
- NIM 8229507STIMULATOR, NERVE1 recall3 reports
- NIM 8229308STIMULATOR, NERVE1 recall2 reports
- NIM 8229306STIMULATOR, NERVE1 recall2 reports
- NIM 8229308STIMULATOR, NERVE1 recall0 reports
- NIM 8229506STIMULATOR, NERVE1 recall0 reports
- NIM 8229508STIMULATOR, NERVE1 recall0 reports
- NIM® 8253402STIMULATOR, NERVE31 reports
- NIM 8225825XSTIMULATOR, NERVE5 reports
- NIM® 8229307STIMULATOR, NERVE2 reports
Recent NIM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726075 ↗MalfunctionAug 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that intra-op, the NIM 3.0 device was not working - any signal from stimulation; not even negative; they tried to use a lot of different probes. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266288 ↗MalfunctionJun 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, MAINFRAME WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25605738 ↗MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE MAINFRAME WAS NOT WORKING PROPERLY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25274727 ↗MalfunctionMay 25, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING PRE-OP, THE NIM HAD NO STIM RESPONSE. SOMETIMES THE CHANNEL FUNCTION DOESN'T WORK PROPERLY AND THERE IS NO RESPONSE TO STIMULATION. ONE CHANNEL'S STIMULATION FEEDBACK IS 0, WHILE THE OTHERS ARE NORMAL. CHANNEL 1 HAS NO WAVEFORM AND NO STIMULATION FEEDBACK SOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273445 ↗MalfunctionMay 19, 2026False Negative Result
IT WAS REPORTED THAT PRE-OP, THERE WAS NO STIMULATION RESPONSE. PROCEDURE WAS COMPLETED USING OTHER EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212443 ↗MalfunctionMay 7, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PRE-OP, THE MAINFRAME WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108387 ↗MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE MAINFRAME WAS NOT WORKING PROPERLY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25030402 ↗MalfunctionApr 13, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT INTRA OPERATIVELY, THAT THE INCREMENTING PROBE IS NOT FUNCTIONING. THE PROBE WAS STILL STIMULATING AND THEY WERE STILL RECEIVING POSITIVE NERVE CONFIRMATION HOWEVER, THE INCREMENTING PORTION WAS NOT FUNCTIONING. THE PROBE GAVE READINGS OF 1.0. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859783 ↗MalfunctionApr 13, 2026Signal Artifact/Noise; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT DURING INTRA-OP, THE NIM 3.0 HAD INTERFERENCE LEVELS EXCESSIVELY HIGH, TO THE POINT THAT STIMULUS DETECTION WAS NOT POSSIBLE. THE SIGNAL WAS COMPARABLE TO A MONOPOLAR ELECTRODE WITHOUT A SILENCER, PRESENTING CONSTANT HIGH-AMPLITUDE OSCILLATIONS AND A CONTINUOUSLY REPETITIVE PATTERN, ALONG WITH A PERSISTENT STIMULATION ALERT TONE. THIS CONDITION REMAINED CONSTANT THROUGHOUT THE ENTIRE PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24854680 ↗MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT DURING USE, NIM CONSOLE HAD INTERMITTENT SYSTEM FAILURES STARTUP ERRORS, EXCESSIVE INTERFERENCE, AND DISABLED EMG MONITORING DESPITE CONSISTENTLY PASSING ALL TESTS AND CHECKS. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO DETECT ANY TYPE OF SIGNAL, NEITHER NEURAL ACTIVITY NOR INTERFERENCE, INCLUDING NO SIGNAL FROM THE UNSILENCED ELECTRODE. A FULL SYSTEM CHECK WAS PERFORMED MULTIPLE TIMES, INCLUDING REPEATED TEST FUNCTION VERIFICATION, CONSISTENTLY CONFIRMING PROPER SYSTEM PERFORMANCE. CONNECTIONS, CONFIGURATIONS, AND OTHER PARAMETERS WERE REVIEWED WITHOUT SUCCESS. DURING THE FINAL 15 MINUTES OF THE PROCEDURE, THE PHYSICIAN DECIDED TO USE A PERSONAL PORTABLE DEVICE. UPON STIMULATION WITH THAT DEVICE, A SIGNAL WAS DETECTED ON OUR SYSTEM (WITHOUT ANY CHANGES MADE SINCE THE LAST TEST, DURING WHICH NO SIGNALS HAD BEEN DETECTED). AT THAT POINT, I SUGGESTED THAT THE PHYSICIAN ATTEMPT NERVE STIMULATION AGAIN, RESULTING IN A POSITIVE RESPONSE, ALTHOUGH WITH LOW AMPLITUDE (100 V). THIS EVENT WAS RECORDED AND SUBSEQUENTLY SAVED TO A USB DRIVE. THE SYSTEM HAD PASSED THE TEST FUNCTION SUCCESSFULLY. FOLLOWING THE ISSUE, STANDARD TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24842395 ↗MalfunctionMar 30, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT AFTER THE OPERATION, THE NIM SYSTEM CRASHED EVERY TIME. THE PROTOCOL WAS SAVED TO A USB STICK. NO LOG COULD BE SAVED. SINCE THERE WAS NO INTERNAL MEMORY ON THE DEVICE, THE DATA COULD NO LONGER BE SAVED EITHER.THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24725700 ↗MalfunctionMar 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION RECEIVED STATING THAT THE DEVICE WAS UNABLE TO START/OPERATE NORMALLY, WHICH LED TO INTERRUPTION IN INTENDED USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24542619 ↗MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Unintended Deflation
IT WAS REPORTED THAT DURING INTRA-OP, AFTER CONNECTION, THE MAIN UNIT DISPLAYED A SELF-TEST FAILURE. RECONNECTION WAS PERFORMED, BUT THE DEVICE REMAINED UNRESPONSIVE. REPLACING THE TUBE WITH THE NEW ONE RESOLVED THE ISSUE, LEADING TO THE CONCLUSION THAT THE TUBE HAD POOR CONTACT AND WAS UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438688 ↗MalfunctionFeb 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED DURING SETUP THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288689 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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