Level 1 L1-CW-120VRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 15019517121551), received between Apr 28, 2021 and Jan 7, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Melted

  IT WAS REPORTED THAT THE DEVICE HAD EXPERIENCED AN EVENT WHERE IT HAD BEEN RUNNING DURING A FUNCTIONAL TEST, A POP HAD BEEN HEARD, AND IT HAD LOST ALL POWER. REPORTER STATED IT HAD SOUNDED LIKE A BLOWN FUSE. EVALUATION OF THE RETURNED DEVICE FOUND THERE WAS EVIDENCE OF BURNING/MELTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988871 ↗
• MalfunctionNov 10, 2025Melted; Smoking; Melted; Smoking

  IT WAS REPORTED THAT THE DEVICE EXHIBITED SMELL OF BURNING WHEN TURNED ON. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510859 ↗
• MalfunctionJul 22, 2025Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE HEATER WAS PRODUCING A TERRIBLE BURNING SMELL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565906 ↗
• MalfunctionMay 1, 2025Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  IT WAS REPORTED THAT THE DEVICES' TEMPERATURE LEVEL WAS EXCEEDING THE CUT OFF LIMITS FROM 37C DEGREES. THE SITE NOTICED A FLASHING ERROR ALARM AND IMMEDIATELY SENT THE DEVICE FOR TESTING. WHILE TESTING, IT WAS NOTICED THAT THE TEMPERATURE CONTINUALLY CLIMBED PAST THE SET TEMPERATURE AS IT EXCEEDED PAST 63C DEGREES AND OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944739 ↗
• MalfunctionFeb 25, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE OPERATOR OF THE DEVICE WAS UNABLE TO CLEAR THE OVER TEMP ALARM. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463427 ↗
• MalfunctionFeb 19, 2025Electrical /Electronic Property Problem; Insufficient Heating; Electrical /Electronic Property Problem; Insufficient Heating

  IT WAS REPORTED THAT THE DEVICE DID NOT WORK PROPERLY IN THE INSTANCE THAT IT WAS NOT WARMING UP. THERE WERE NO PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415391 ↗
• MalfunctionJan 27, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT THE EQUIPMENT STOPS, AND SERVICE INDICATOR LIT CONSTANT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240913 ↗
• MalfunctionNov 14, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS STATED THAT THE DEVICE SHUT DOWN DURING OPERATION ON SEVERAL OCCASIONS. THE MAINTENANCE LIGHT BLINKED, AND OCCLUSION INDICATOR STAYED LIT. THE MOTOR STOPPED, AND AN ALARM SOUNDED. IT MAY WORK FOR A WHILE AFTER RESTART, BUT THE ISSUE OCCURRED MULTIPLE TIME. THE HOSE AND COUPLING WERE PROPERLY ATTACHED. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689825 ↗
• MalfunctionNov 14, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS STATED THAT THE THERMISTOR CONNECTION FAILURE WAS SUSPECTED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685578 ↗
• MalfunctionNov 1, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE ¿ORANGE KEY BLINKS -CANNOT START DEVICE¿. THERE IS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592611 ↗
• MalfunctionOct 21, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE DEVICE DID NOT DELIVER HEAT AND ALL LIGHTS COME ON. THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501247 ↗
• MalfunctionSep 24, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE DOESN'T HEAT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296545 ↗
• MalfunctionSep 18, 2024Temperature Problem; Activation Problem; Temperature Problem; Activation Problem

  IT WAS REPORTED THAT THERE WAS AN INTERMITTENT ISSUE WHEN TURNING OFF THE UNIT. EVERYTHING IN INTERNAL STOPPED EXCEPT DISPLAY TEMPERATURE WHICH DECREASED SLOWLY INSTEAD OF AN IMMEDIATE STOP. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250595 ↗
• MalfunctionSep 16, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THEY ARE GETTING 50 DEGREES CELSIUS ON THEIR WARMER USING "FLUKE THERMOCOUPLER". THEY HAVE VERIFIED ALL TEMP CHECKS (37, 40 AND 43 DEGREE CELSIUS) AND CLEARED DUST FROM FILTER. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231145 ↗
• MalfunctionSep 5, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE ¿ORANGE KEY BLINKS -CANNOT START DEVICE.¿ THERE IS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148073 ↗
• MalfunctionSep 5, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE ¿ORANGE KEY BLINKS -CANNOT START DEVICE¿. THERE IS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148071 ↗
• MalfunctionAug 26, 2024Improper Flow or Infusion; Noise, Audible; Improper Flow or Infusion; Noise, Audible

  IT WAS REPORTED THAT THE PRODUCT MAKES STRANGE NOISES AND STOPS FREQUENTLY. EVENT OCCURRED WHILE PATIENT USE, DURING INFUSION. THERE WAS KNOWN PATIENT INVOLVEMENT AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070907 ↗
• MalfunctionAug 15, 2024Device Emits Odor; Unexpected Shutdown; Device Emits Odor; Unexpected Shutdown

  IT WAS REPORTED THAT THE WARMER STOPS RUNNING AFTER A FEW MINUTES AND SMELLS OF BURNING COMPONENTS/ELECTRONICS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995170 ↗
• MalfunctionJul 8, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT REGULATING TEMPERATURE CORRECTLY. THE WHOLE SYSTEM NEEDED TO BE CHECKED ENSURE IT WAS FUNCTIONING AND NO LEAKS. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697316 ↗
• MalfunctionJul 5, 2024Device Alarm System; Device Sensing Problem; Device Alarm System; Device Sensing Problem

  IT WAS REPORTED THAT WITH THE DEVICE THE ALARM STILL GOES OFF WHEN IT IS REPLACED WITH A SENSOR AND ALSO GOES OFF WHEN IT IS REPLACED WITH ANOTHER HOSE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684454 ↗
• MalfunctionJul 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE, THE TOOL MARK INDICATOR AND THE BLOCKAGE MARK INDICATOR WERE NOT WORKING. NO HEALTH CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651772 ↗
• MalfunctionJun 27, 2024Device Alarm System; Key or Button Unresponsive/not Working; Device Alarm System; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THERE WAS AN ERROR WAS REPRODUCED ON THE BENCH. IT WAS ALSO REPORTED THAT THE DEVICE SHUTS DOWN INTERMITTENTLY. THIS OCCURS FROM A FEW MINUTES TO 20-30 MINUTES, AND SOMETIMES OPERATES THE ENTIRE DAY WITHOUT ANY PROBLEMS. IT HAPPENED AFTER APPROXIMATELY 2-3 MINUTES AT 43 DEGREES. HOWEVER, IT WAS RUN AGAIN IMMEDIATELY AFTERWARDS WITHOUT ANY PROBLEMS FOR OVER 30 MINUTES. THE ISSUE WAS REPRODUCED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629639 ↗
• MalfunctionJun 27, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE DEVICE WAS NOT HEATING UP. FOUND WHILE STAFF WAS SETTING UP FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627949 ↗
• MalfunctionMar 2, 2023Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE DEVICE IS PRESENTING WITH INTERMITTENT HEATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475411 ↗
• MalfunctionSep 6, 2022Device Alarm System; Overheating of Device; Device Alarm System; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HAD OVER TEMP/AUDIO ALARM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361695 ↗