NIM-ECLIPSE® ECLC (UDI 00643169786653)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169786653), received between Jul 31, 2020 and Aug 25, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (29 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionSep 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE NIM ECLIPSE CONTROLLER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23174703 ↗
• MalfunctionAug 18, 2025Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE RETURNED FOR PLANNED MAINTENANCE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824715 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DEVICE HAD NON-SPECIFIED ISSUE. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505627 ↗
• MalfunctionJun 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE NIM ECLIPSE WAS NOT WORKING PROPERLY. REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157154 ↗
• MalfunctionMay 12, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT PRE OP, THE CONTROLLER NOT COMMUNICATING WITH LAPTOP. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001322 ↗
• MalfunctionMay 5, 2025Computer Software Problem; Unable to Obtain Readings; Computer Software Problem; Unable to Obtain Readings

  IT WAS REPORTED THAT PRIOR TO USE, ELCIPSE HAD INTERMEDIATE CONNECTION LOSS AND RESPONSE NOT SHOWING AND HAD SOFTWARE-PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959144 ↗
• MalfunctionMar 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ECLC COMPUTER, DURING A SIMULATION, THE SIGNAL LABELS TURN RED WHILE THE IMPEDANCE MEASUREMENTS ARE CORRECT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705320 ↗
• MalfunctionMar 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE ECLIPSE WOULD NOT CONNECT. THE NIM SCREEN WAS FLASHING ¿NOT COMMUNICATING¿ AND NO LIGHTS ON THE ELECTRODE INTERFACE. THE ISSUE IDENTIFIED ON SET UP. AN ALTERNATIVE NIM WAS USED FOR THE EVENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606710 ↗
• MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER TURNING IT ON, THE HOST COULDN'T DETECT THE ELECTRICAL STIMULATION BOX. AFTER REPEATED TESTS, THE FAULT STILL COULDN'T BE RESOLVED, AND THE DEVICE WAS STOPPED USING. ALSO THE DEVICE COULD NOT RECOGNIZE THE STIMULATOR EXTENDER. THIS DEVICE WAS USED TO DIAGNOSE NERVES DURING BRAIN SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569701 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE ECLIPSE AND STIMULATOR HAD THE CONNECTION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562540 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED DURING PRE-OP FOR SCOLIOSIS PROCEDURE THAT THE DEVICE HAD NON-SPECIFIED. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504790 ↗
• MalfunctionMar 3, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT PRE-OP, NIM ECLIPSE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502589 ↗
• MalfunctionMar 3, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502249 ↗
• MalfunctionMar 3, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT PRE-OP, STIMULATION MODULE NOT DETECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501721 ↗
• MalfunctionFeb 20, 2025Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE OP MODULE THAT CONNECTS THE PATIENT ELECTRODES TO THE CONSOLE DOES NOT RECOGNIZE THE HEADREST AND IT IS A RECURRING PROBLEM. IT RESOLVES BY TURNING OFF AND ON BUT THE PROBLEM BECOMES MORE AND MORE PRESENT. ALSO, DURING USE, SETTINGS CHANGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429298 ↗
• MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  IT WAS REPORTED THAT CONNECTION FAILURE WITH THE APP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396228 ↗
• MalfunctionJan 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PRE-OP, ECLC PREAMP WAS BROKEN AND NO COMMUNICATION OF PREAMP-A. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21238530 ↗