NIM-ECLIPSE® ECLC (UDI 00643169378469)Recalls & reported problems
Medtronic Xomed, Inc. · CONTROLLER ECLC ECLIPSE ROHS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic NIM-ECLIPSE controller, the screen unit used to monitor nerve signals during surgery. Most of the 51 reports describe the unit not working before an operation — failing to power on, losing its connection to the control station, showing error messages, or not displaying signals properly, with procedures sometimes completed without it. There are no deaths and 2 injuries, and no recalls name 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
- 51
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00643169378469), received between Feb 20, 2018 and Apr 24, 2026 — classified as 2 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (33 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem33
- Unable to Obtain Readings7
- Incorrect, Inadequate or Imprecise Result or Readings5
- Break3
- Connection Problem3
- Display or Visual Feedback Problem3
- Loose or Intermittent Connection2
- Activation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient16
- Death1
- Insufficient Information1
- No Code Available1
- No Patient Involvement1
- Paraplegia1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
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 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 ↗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 ↗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 ↗MalfunctionOct 17, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE NIM CONTROLLER WAS NOT FUNCTIONAL. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320622 ↗MalfunctionSep 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT INTRA-OP, WHEN THE ORTHOPEDIC TEAM USED ECLC DEVICE THE SIGNAL-RECEIVING AMPLIFIER ON THE LEFT SIDE MALFUNCTIONED AND FAILED TO DISPLAY ON THE SCREEN, PREVENTING THE DOCTOR FROM FULLY MONITORING SPINAL CORD ELECTRICAL SIGNALS, WHICH SIGNIFICANTLY INCREASED THE RISK OF THE SURGERY. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23081613 ↗MalfunctionAug 25, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT BEFORE THE OPERATION, THE ECLC CONTROLLER WAS NOT WORKING PROPERLY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883791 ↗MalfunctionJul 18, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT BEFORE OPERATION NIM ECLIPSE SYSTEMS WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540734 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT DEVICE HAD NON SPECIFIC DAMAGE ISSUE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505683 ↗MalfunctionJul 11, 2025No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478111 ↗MalfunctionMar 14, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT BEFORE OPERATION DEVICE HAD NO STIMULATION RESPONSE. CURRENT STIM RETURN SHOWED "0", INDICATING THAT CURRENT IS NOT BEING DELIVERED. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605755 ↗MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SET-UP, THE PREAMPLIFIER WAS NOT RECOGNIZED BY THE MAIN SYSTEM OF ECLC. THE HEAD REGISTERS BUT DOES NOT DELIVER AND THERE WAS A VISUAL INDICATOR OF ERROR MESSAGE PRESENT INDICATING THE ISSUE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21566753 ↗MalfunctionMar 7, 2025Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem
IT WAS REPORTED THAT THE STIMULATION CONTROLLER WAS NOT WORKING PROPERLY AND WILL NOT STIMULATE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543624 ↗MalfunctionMar 3, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT BEFORE THE OPERATION, THE CONTROLLER ECLIPSE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21502195 ↗MalfunctionFeb 26, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT DURING PROCEDURE, WHEN RUNNING A TCEMEP THE PROGRAM ON THE COMPUTER READ THAT THE VOLTAGE WAS DELIVERED BUT THE CURRENT WAS MUCH LOWER AND NO RESPONSES SEEN OVER MUSCLES. AFTER THIS, A STIMULATION NO LONGER DELIVERED ANY CURRENT AT ALL (READ OUT 0 ON THE MACHINE). A NEW STIMULATOR BOX AND CORD WERE BOTH USED, AND THE PROBLEM WAS NOT RESOLVED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21466325 ↗MalfunctionDec 30, 2024Use of Device Problem; Use of Device Problem
INFORMATION RECEIVED BY MEDTRONIC THAT THE NIM ECLIPSE WAS RETURNED WITH ALLEGED DEFECT WITH NO CUSTOMER COMMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036707 ↗MalfunctionOct 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT NIM CONTROLLER WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502553 ↗MalfunctionOct 16, 2024Use of Device Problem; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT DEVICE HAD LOW SOFTWARE VERSION. THE OPERATING SOFTWARE VERSION WAS 4.2.423, AND THE FILES IN THE SOFTWARE WERE DELETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20458441 ↗MalfunctionSep 17, 2024Loose or Intermittent Connection; Intermittent Loss of Power; Loose or Intermittent Connection; Intermittent Loss of Power
IT WAS REPORTED THAT DURING TESTING, ECLIPSE DISCONNECTS INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238495 ↗MalfunctionSep 3, 2024Unable to Obtain Readings; Unable to Obtain Readings
ADDITIONAL INFORMATION RECEIVED STATED THAT IT WAS NOT POSSIBLE TO ENTER THE PATIENT'S NAME IN THE SYSTEM. THE ISSUE WAS NOT RESOLVED WITH REPOSITIONING OR TROUBLESHOOTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126176 ↗MalfunctionAug 23, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING USE, THE ECLC CONTROLLER WOULD MAKE A LOUD POPPING SOUND (NOT FROM THE LAPTOP) AT WHICH TIME THE COMPUTER PROGRAM WOULD CEASE TO RUN FOR 5-10 MINUTES. THE ECLC WOULD MAKE ANOTHER POP SOUND BEFORE THE PROGRAM WOULD RESTART RANDOMLY. THE USER ATTEMPTED TO CHANGE THE USB INTERFACE CABLE AND RESTART THE PROGRAM, HOWEVER THIS DID NOT WORKED. ULTIMATELY, SWAPPED THE BROKEN ECLC WITH ANOTHER AND EVERYTHING WORKED FINE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20051434 ↗MalfunctionAug 13, 2024Loose or Intermittent Connection; Use of Device Problem; Loose or Intermittent Connection; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED: DAQ PORT OF CONTROLLER FAILURE, DAQ UNIT DISCONNECTED ERROR POPUP SHOWN ON LAPTOP SCREEN. DAQ916 UNIT DISCONNECTS INTERMITTENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970194 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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