NIM-ECLIPSERecalls & reported problems across all models
Medtronic Xomed, Inc. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 145
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 7 models of NIM-ECLIPSE by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 145 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2017 and Aug 25, 2026 — classified as 2 injuries, 143 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (91 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-ECLIPSE problems
Device problems
- Use of Device Problem91
- Unable to Obtain Readings20
- Incorrect, Inadequate or Imprecise Result or Readings15
- Break7
- Display or Visual Feedback Problem7
- Failure to Sense6
- Connection Problem5
- Device Sensing Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions108
- No Consequences Or Impact To Patient31
- No Known Impact Or Consequence To Patient5
- Insufficient Information2
- No Patient Involvement2
- Death1
- No Code Available1
- Numbness1
NIM-ECLIPSE models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIM-ECLIPSE® ECLCFull-montage Standard Electroencephalograph53 reports
- NIM-ECLIPSE® ECLCTransducer, ultrasonic, diagnostic51 reports
- NIM-ECLIPSE® ECLCSTIMULATOR, ELECTRICAL, EVOKED RESPONSE35 reports
- NIM-Eclipse® NCCPUSTIMULATOR, AUDITORY, EVOKED RESPONSE2 reports
- NIM-ECLIPSE® NCCPUSystem, imaging, pulsed doppler, ultrasonic2 reports
- NIM-Eclipse® NWCPUSystem, imaging, pulsed doppler, ultrasonic1 report
- NIM-ECLIPSE® NCCPUSTIMULATOR, ELECTRICAL, EVOKED RESPONSE1 report
Recent NIM-ECLIPSE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50424717 ↗MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, ECLC NOT WORKING AND EXTERNAL TRIGGER OUT PORT 2 WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24976844 ↗MalfunctionApr 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE DEVICE WAS NOT SHOWING GRAPH PROPERLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24869300 ↗MalfunctionMar 13, 2026Unable to Obtain Readings
IT WAS REPORTED THAT DEVICE WAS NOT STIMULATING AND HAS BROKEN PINS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24596780 ↗MalfunctionMar 6, 2026Unable to Obtain Readings
IT WAS REPORTED THAT PRE-OP, THE ECLC HAD A ERROR MESSAGE STATING THE CONTROL STATION NOT CONNECTED. THE PROCEDURE WAS COMPLETED WITHOUT THE ECLC. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24527978 ↗MalfunctionMar 2, 2026Use of Device Problem
IT WAS REPORTED THAT THE COMPUTER HAD FAILURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481294 ↗MalfunctionMar 2, 2026Use of Device Problem
IT WAS REPORTED THAT PRE-OP, THE CONTROLLER DOESN'T WORK PROPERLY SOMETIMES. THE ISSUE WAS NOT RESOLVED WITH REPOSITIONING OR TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480822 ↗MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED INTRA-OP, THAT THE SYSTEM WAS SENDING IMPULSES WHEN NO INPUT WAS MADE AND NO RESPONSES WERE NOTED ON THE SYSTEM BUT THE PATIENT VISIBILITY SHOOK. THE ISSUED WAS RESOLVED BY SWAPPING THE BASE UNIT. THE ISSUE WAS NOT RESOLVED, TRIED MULTIPLE CABLES AND DAQS. ALL DAQS AND CABLES WORK ON EITHER BASE UNITS. MULTIPLE PROTOCOLS WERE USED INTERCHANGEABLY, THERE WAS NO ISSUE WITH THE DAQS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453570 ↗MalfunctionJan 23, 2026Connection Problem
IT WAS REPORTED THAT DURING PRE-OP, THE NIM ECLIPSE MODULE WAS NOT COMMUNICATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159221 ↗MalfunctionJan 13, 2026Use of Device Problem
IT WAS REPORTED THAT DEVICE NOT WORKING PROPERLY AND REQUESTED PM. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050422 ↗MalfunctionJan 5, 2026Use of Device Problem
IT WAS REPORTED THAT DURING USE OF THE SYSTEM WITH A SINGLE DAQ UNDER HIGH INPUT LOAD, ONE OR TWO INPUT CHANNELS BECAME GREYED OUT AND THOSE INPUTS OCCASIONALLY MOVE AS TO WHICH IT IS. WHEN OPERATING A LOADED BOX AND A TEMPLATE IS BUILT THEN A 2ND SET IS ALSO USED TO BUILD A TEMPLATE AND IT HAS EMG, EEG, SEP IN DIFFERENT SETS, WHEN SWITCHED BETWEEN THE SETS ANY INPUTS THAT WERE ALLOCATED TO MORE THAN ONE TEST WAS PAUSED. FOR EXAMPLE, IN SET 1 IF IT HAD 16 CHANNELS OF EMG AND IN SET 2 IT HAD MULTIPLE SEP CHANNELS, IF ANY OF THOSE WERE OVERLAPPING USED CHANNELS IN SET 1 THAT CHANNEL WAS PAUSED WHILST BEING USED BY THE OTHER SET. THE DAQ AND CABLES WERE CHECKED AND IT WAS WORKING FINE, SO THE ISSUE WAS SUSPECTED TO BE WITH THE ECLC CONTROLLER. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23955351 ↗MalfunctionDec 31, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE DEVICE HAD THE BLACK SCREEN, AFTER WHICH THE ECLC CONTROLLER RESTARTS ITSELF, AS IF IT HAD COME OUT OF SLEEP MODE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933864 ↗MalfunctionDec 19, 2025Use of Device Problem; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED THAT DURING THE CASE, THE CONTROLLER WAS NOT ABLE TO CONNECT EVEN AFTER CHANGING THE USB CABLE. SYSTEM WAS FAILING SELF TEST. STIMULUS WAS TO 200-300 MICRO VOLTS AND EVENTUALLY USED TO SET ACCORDING TO THE CASE WITH A THRESHOLD TO 50-60A.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846992 ↗MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED, THERE WAS NO OTHER ISSUE FROM NIM APART FROM THE ERROR MESSAGE. AND ONLY ONE STIMULATOR EXTENDER WAS USED IN THIS EVENT, DID NOT TRY WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566411 ↗MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT NIM ECLIPSE WAS FAULTY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23507787 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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