N/A 945ECLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169071872), received between Aug 3, 2017 and Nov 17, 2025 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED THAT THE NIM ECLIPSE CONTROLLER GETS DISCONNECTED WHEN PLUGGED IN. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23569168 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT NIM ECLIPSE HAD NON-SPECIFIC DAMAGED ISSUE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567053 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CONTROLLER WAS NOT RECOGNIZING STIM BOX. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22892157 ↗
• MalfunctionAug 18, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT ECLC CONTROLLER WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22836308 ↗
• MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICE WAS NOT WORKING DAQ A DEFECTIVE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22824912 ↗
• MalfunctionAug 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE STIM BOX WAS NOT DETECTED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22824718 ↗
• MalfunctionAug 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CONTROLLER HAD BAD STIM BOARD WITH NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22824714 ↗
• MalfunctionAug 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE HAD DAQ BOARD OUT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22824662 ↗
• MalfunctionAug 17, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE NIM ECLIPSE HAD CONNECTION FAILURE. THERE WAS NO KNOWN PATIENT IMPACT IN THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22824572 ↗
• MalfunctionMar 6, 2025Device Displays Incorrect Message; Device Sensing Problem; Device Displays Incorrect Message; Device Sensing Problem

  IT WAS REPORTED THAT DAQ B DOES NOT APPEAR TO BE RECOGNIZED. AN ERROR MESSAGE WAS DISPLAYED ABOUT DAQ B WHEN MODALITIES RECORDING FROM THAT BOX ARE TURNED ON. ADDITIONALLY, THE IMPEDANCE CHECK ONLY SHOWED GREY BOXES FOR PROGRAMMED INPUTS. THIS ISSUE WAS CONFIRMED WITH DIFFERENT CABLES, DAQ BOXES, AND CONTROLLERS. THE CONTROLLER WAS SWAPPED OUT TO COMPLETE THE CASE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21539636 ↗
• MalfunctionDec 30, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT ECLC CONTROLLER HAD NO STIM RETURN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034559 ↗
• MalfunctionSep 9, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED DURING INTRA-OP THAT THE SYSTEM WAS NOT RECOGNIZE THE EEX 901S. CABLES AND BOXES WERE SWAPPED, HOWEVER THE ONLY THING THAT RESOLVED IT WAS TO CHANGE THE BASE UNIT. NO ISSUES AROSE WITH THE SAME BOXES AND CABLES WITH A NEW BASE. ADDITIONALLY, THE TECHNOLOGIST HAS REPORTED ONGOING ISSUE WITH 60HZ OUTSIDE OF NORMAL AND WITHOUT A IDENTIFIABLE SOURCE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167320 ↗
• MalfunctionAug 22, 2024Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED THAT DAW B INTERMITTENTLY DROPS OUT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028559 ↗
• MalfunctionMay 24, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE NIM HAD RECUURENT STIM OUTPUT FAILURE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990487 ↗
• MalfunctionMar 6, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A PROCEDURE PERFORMED IN THE OPERATING ROOM DURING WHICH ONE OF THE TECHS WAS USING A MEDTRONIC E4 MACHINE. THE PATIENT REPORTEDLY HAD A POOR OUTCOME, AND THE HOSPITAL HAS REQUESTED THAT A CERTIFIED MEDTRONIC REPRESENTATIVE TEST THE EQUIPMENT TO ENSURE IT IS IN PROPER WORKING CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485228 ↗
• MalfunctionMay 25, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE PREAMP B IS NOT WORKING .NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495651 ↗
• MalfunctionApr 29, 2022Device Sensing Problem; Device Sensing Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CONTROLLER DELIVERS NO MOTOR STIM AND INCONSISTENT SENSORY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253158 ↗
• InjuryMar 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HCP REPORTED THAT WHILE MONITORING A LUMBER FUSION CASE, AND HAD PLACED AN ANODE NEEDLE ELECTRODE TO USE WITH PROBE FOR SCREW TESTING. WHEN PATIENT WOKE UP, THERE WAS A THIRD DEGREE BURN AT THE SITE OF THE ANODE NEEDLE. ELECTROCAUTERY WAS ALSO USED BY SURGEON DURING PROCEDURE. AFTER THE INTERNAL TESTING RESULTS CAME BACK AS THE MACHINE TESTING NORMAL, THE USER SUSPECT THAT THE ELECTROCAUTERY MACHINE WAS NOT PROPERLY GROUNDED AND FOUND A PATH THROUGH THE IOM PLACED NEEDLE.

  Patient problems: Burn(s)

  MAUDE report 13884725 ↗
• MalfunctionMar 1, 2021Device Sensing Problem; Device Sensing Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CONNECTOR FAILED WHEN CONNECTED TO PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391813 ↗
• MalfunctionDec 28, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE CONTROLLER WAS HAVING ISSUES WITH ACQUIRING MOTOR EVOKED POTENTIALS (MEP). NO RESPONSE WAS ACHIEVED AFTER HAVING A VOLTAGE UP UNTIL 700 VOLTS. THE PATIENT WOULD SOMETIMES REACT TO THE STIMULUS AND SOMETIMES THERE IS NO REACTION. NO BACK-UP DEVICE WAS USED AND THERE WERE NO ISSUES DURING THE PROCEDURE BUT MEP WAS NOT RUN AT THE TIME. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8204017 ↗
• MalfunctionDec 14, 2018Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PREAMPLIFIER B PORT NEEDED REPAIR AND THAT THE DEVICE WAS NOT WORKING PROPERLY DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8164326 ↗
• MalfunctionNov 20, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS NOT PRODUCING A HIGH STIMULUS; WHEN BOTH STIMULATORS WERE PLUGGED IN THEY WERE GETTING AN ELECTRICAL STIM FAILURE; TRIED WITH TWO OTHER STIMULATORS ON THE SAME DEVICE AND HAD THE SAME ISSUE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090442 ↗
• MalfunctionAug 2, 2018Intermittent Continuity; Loss of Power; Use of Device Problem; Intermittent Continuity; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CONTROLLER WAS INTERMITTENTLY NOT WORKING AND SHUTS DOWN IN THE MIDDLE OF CASES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7741995 ↗
• MalfunctionAug 3, 2017Sensing Intermittently; Sensing Intermittently

  THE FACILITY REPORTED THAT PRE-OPERATIVE THE DEVICE HAD AN INTERMITTENT STIM OUTPUT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765279 ↗