NIM-NeuroRecalls & reported problems across all models
Medtronic Xomed, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 186
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 9 models of NIM-Neuro by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 186 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Sep 28, 2026 — classified as 4 injuries, 182 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (75 reports).
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
Most reported NIM-Neuro problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings75
- Use of Device Problem42
- False Negative Result18
- Break14
- Inappropriate Audible Prompt/Feedback11
- Failure to Sense10
- Device Sensing Problem9
- Device Operates Differently Than Expected7
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- No Consequences Or Impact To Patient31
- No Known Impact Or Consequence To Patient7
- No Patient Involvement5
- Nerve Damage2
- Complaint, Ill-Defined1
- Facial Nerve Paralysis1
- Unspecified Tissue Injury1
NIM-Neuro models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIM-Neuro® 8253402STIMULATOR, ELECTRICAL, EVOKED RESPONSE53 reports
- NIM-Neuro® 8253410STIMULATOR, NERVE48 reports
- NIM-Neuro® 8253410STIMULATOR, ELECTRICAL, EVOKED RESPONSE29 reports
- NIM-Neuro® 8253402STIMULATOR, ELECTRICAL, EVOKED RESPONSE27 reports
- NIM-Neuro® 8253410STIMULATOR, ELECTRICAL, EVOKED RESPONSE13 reports
- NIM-Neuro® 8253401STIMULATOR, ELECTRICAL, EVOKED RESPONSE11 reports
- NIM-Neuro® 8253401STIMULATOR, ELECTRICAL, EVOKED RESPONSE3 reports
- NIM-Neuro® 8253401STIMULATOR, ELECTRICAL, EVOKED RESPONSE1 report
- NIM-Neuro® 8253401STIMULATOR, ELECTRICAL, EVOKED RESPONSE1 report
Recent NIM-Neuro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that pre op, the patient interface was not delivering current on both stim port. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911742 ↗MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50050619 ↗MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE PATIENT INTERFACE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280541 ↗MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION RECEIVED STATING NIM SYSTEM FAILED SELF TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244572 ↗MalfunctionApr 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, NIM PATIENT INTERFACE HAD NO STIMULATION CURRENT. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24882307 ↗MalfunctionApr 13, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PREOPERATIVELY, THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854602 ↗MalfunctionApr 8, 2026Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT INTRA-OP DURING THYROID PROCEDURE, THE PATIENT INTERFACE HAD A LOT OF INTERFERENCE. THEY USED ANOTHER INTERFACE AND IT WORKED PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24812802 ↗MalfunctionApr 7, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NOT WORKING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796553 ↗MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT, THE NIM MAINFRAME WAS LOOSING SIGNAL. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566208 ↗MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE NIM WAS NOT WORKING, "INADEQUATE ABLATION, NO OUTPUT OR ERROR MESSAGE". BASIC TROUBLESHOOTING WAS PERFORMED, INCLUDING CHECKING CONNECTIONS, VERIFYING SETTINGS, AND REPLACING THE DISPOSABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING AN ALTERNATE UNIT, THE NIM MAINFRAME WAS FUNCTIONING PROPERLY WITH NO ERROR MESSAGES OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531530 ↗MalfunctionFeb 5, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SET-UP THE NIM 3.0 PATIENT INTERFACE PROVIDED THE NO STIMULATION RESPONSE. THE STIM RETURN ON THE MONITOR SHOW (0) WHEN ATTEMPTING TO DELIVER STIMULUS. THERE WAS NO STIMULUS DELIVERY TONE HEARD AND NO WAVEFORM DISPLAYED, WHEN ATTEMPTING TO STIMULATE THE NERVE THE PROCEDURE WAS COMPLETED WITH ANOTHER EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24275209 ↗MalfunctionJan 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT DURING THYROIDECTOMY SURGERY, THERE WAS NO PROPER TRANSMISSION OF THE ELECTRICAL SIGNAL. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING AT THE TIME OF THE EVENT. THERE WAS NO PATIENT IMPACT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24127937 ↗MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE NIM MAINFRAME SENOR CONTACT WAS NOT GOOD. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096456 ↗MalfunctionJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NOT WORKING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24033207 ↗MalfunctionDec 22, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
ADDITIONAL INFORMATION RECEIVED AS THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861552 ↗
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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