NIM-Neuro® 8253410 (UDI 00643169782464)Recalls & reported problems
Medtronic Xomed, Inc. · PATIENT INTFC 8253410 NIM NEURO 3.0 ROHS · Class 2
All models of NIM-Neuro (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic NIM-Neuro patient interface is used to monitor nerves during surgery. The 47 reports mostly describe the unit not working or giving unreliable readings before or during operations, with interference, error messages, and a few cases of broken parts; in most reports no patient was affected and procedures were finished using a different unit. No deaths or injuries are reported, and there are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00643169782464), received between Apr 11, 2019 and Sep 28, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings25
- Use of Device Problem11
- Break4
- Inappropriate Audible Prompt/Feedback4
- False Negative Result3
- Device Sensing Problem2
- Connection Problem1
- Intermittent Communication Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 48 reports, 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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionNov 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING PRE-OP, THE PATIENT INTERFACE AND MAINFRAME CHANNEL WAS NOT WORKING. IT DID NOT DISPLAY NERVE STIMULATION IN A CRANIOTOMY. THEY BROUGHT IN A SECOND SYSTEM; IT DID NOT WORK EITHER. DURING TROUBLESHOOTING THE CASE ENDED AND TESTED THE DEVICE WITH THE PATIENT SIMULATOR AND BOTH UNITS SEEMED TO OPERATE CORRECTLY. THE PROCEDURE WAS COMPLETED WITHOUT NERVE MONITORING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669355 ↗MalfunctionNov 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFORMATION RECEIVED THAT THERE IS NO ALLEGATION AGAINST THE DEVICE AND IT WAS CREATED BY AN ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23641438 ↗MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE PATIENT INTERFACE HAS NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012750 ↗MalfunctionAug 29, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback
IT WAS REPORTED THAT PRE-OP, THE NIM MAINFRAME WAS MAKING STRANGE NOISE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923483 ↗MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING INTRA-OP, NO STIM RESPONSE FROM PI BOX AND DEEMED NOT WORKING PROPERLY. USER USED A DIFFERENT PATIENT INTERFACE AND IT WORKED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22824782 ↗MalfunctionAug 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PATIENT INTERFACE BOX CHANNEL RED 2 WAS NOT WORKING AS WELL AS STIM 1 BOX ALSO NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22684998 ↗MalfunctionJun 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT POST-OP, NIM INTERFACE WAS NOT CONNECTION PROPERLY. THERE WAS NOISE WHEN CONNECTED WITH THE NIM MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202706 ↗MalfunctionApr 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE PATIENT INTERFACE WAS NOT PROVIDING ANY RESPONSE WHEN PLUGGED IN. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932682 ↗MalfunctionMar 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ADDITIONAL INFO INDICATED THAT THE OTHER PATIENT INTERFACE WAS A LOAN UNIT WHICH WAS SENT TO COVER THE REPAIR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21674761 ↗MalfunctionMar 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING TESTING, THE CABLES WERE NOT REGISTERING FROM NIM MODULAR FACE AND MONITOR AND IT WAS INTERMITTENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21603333 ↗MalfunctionMar 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501839 ↗MalfunctionOct 1, 2024False Negative Result; False Negative Result
ADDITIONAL INFORMATION RECEIVED STATING THE ISSUE HAPPENED PRIOR TO PROCEDURE AND TROUBLESHOOTING WAS PERFORMED BY CHANGING THE FUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20341289 ↗MalfunctionSep 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USAGE, THE PATIENT INTERFACE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20221900 ↗MalfunctionJul 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING MIDWAY OF THE CASE, THE PATIENT INTERFACE STOPPED RESPONDING. ATTEMPT TO REPLACE WITH OTHER PROBES AND IT WAS DETERMINED THAT THE PATIENT INTERFACE WAS NOT FUNCTIONING. ANOTHER PATIENT INTERFACE BOX WAS CHANGED OUT WITH THE MONITOR AND FUNCTIONED AGAIN PROPERLY. DELAY TIME DURING TROUBLESHOOTING WOULD HAVE BEEN ABOUT 5 MINUTES. VERISTIM USED DURING THE TROUBLESHOOTING TIMEFRAME UNTIL THE PI BOX WAS SWITCHED OUT. EVENT OCCURRED DURING PAROTID CASE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818128 ↗MalfunctionJun 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING OPERATION, THE PATIENT INTERFACE HAD NO STIMULATION RESPONSE. THE STIM RETURN DID NOT SHOW "0", INDICATING THAT CURRENT WAS BEING DELIVERED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19581420 ↗MalfunctionMay 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT BEFORE OPERATION, THE NIM 3.0 PATIENT INTERFACE HAD A TEST FAILED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19333011 ↗MalfunctionApr 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT IN NIM PATIENT INTERFACE THERE WAS NO SIGNAL. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19200033 ↗MalfunctionApr 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, PATIENT INTERFACE WAS NOT GIVING STIMULATION REPONSE BECUASE OF LOOSE JOINT SOLDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19010424 ↗MalfunctionFeb 4, 2024False Negative Result; False Negative Result
ADDITIONAL INFORMATION STATS THAT STIM RETURN SHOW 0, WHICH WOULD INDICATE THAT CURRENT WAS NOT BEING DELIVERED, THERE WAS VISUAL AND/OR AUDIBLE INDICATOR THAT ALERTED THE USER OF THE ISSUE, USER INDICATES THAT THE INTERMITTENT ISSUE WAS A CONNECTION ISSUE, AND THEY WERE ALERTED BY SOMETHING ON THE SCREEN THAT THE CONNECTION WAS INTERMITTENT AND ISSUE WAS RESOLVED BY REPOSITIONING OR TROUBLESHOOTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18637797 ↗
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-2343-2012 · Sep 27, 2010 · TerminatedInterfaces 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 · TerminatedInterfaces 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
- Z-2342-2012 · Sep 27, 2010 · TerminatedInterfaces 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
Other STIMULATOR, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page