Arctic Sun® Temperature Management System, Temperature Cable Nellcor 73502Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741080296), received between Sep 4, 2020 and May 29, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (32 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS NO FLOW ENOUGH IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 28APR2026, THERE WAS NO PATIENT INVOLVEMENT. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 19MAY2026, IT WAS REPORTED THAT THE LEVEL SENSOR WAS FOUND TO BE BROKEN. THE INPUT/OUTPUT CARD WAS NOT COMMUNICATING CORRECTLY AND WAS GIVING INCORRECT VALUES DURING THE CTU CALIBRATION. THERE WERE CRACKS IN THE FLUID DELIVERY LINE (FDL). TEMPERATURE CABLE WAS NOT DISPLAYING CORRECT TEMPERATURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339998 ↗
• MalfunctionMar 13, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE DID NOT DETECT THE PATIENT'S TEMPERATURE. PER REVIEW OF WO, NO CONSEQUENCE FOR PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 12MAR2026, THE CLIENT REPORTED THAT THIS CONSOLE WAS NO LONGER REACHING THE REQUIRED TEMPERATURE TARGET. THEY HAVE TWO CONSOLES IN THEIR DEPARTMENT. THEY SIMPLY SWITCHED DEVICES TO CONTINUE THE THERAPY. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 20MAR2026, IT WAS REPORTED THAT THERE WERE CRACKS ON THE LEVEL SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594585 ↗
• MalfunctionMar 3, 2026Insufficient Cooling; Device Sensing Problem

  IT WAS REPORTED THAT THE TEMPERATURE SENSOR WAS NOT WORKING PROPERLY AND GIVING INCORRECT MEASUREMENTS. THE DEVICE HAD ALARM 15 UNABLE TO OBTAIN A STABLE PATIENT TEMPERATURE. PER REVIEW OF WO ON 03MAR2026, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 03MAR2026, THIS WO IS AN ONSITE ORDER. SCHEDULED FOR TOMORROW. DEVICE DID NOT COOL PROPERLY. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 06MAR2026, FOR THIS DEVICE, THEIR DELEGATE DETECTED THAT THE MACHINE DID NOT COOL PROPERLY, BUT IT WAS DUE TO A DEFECTIVE TEMPERATURE SENSOR CABLE. THE TECHNICIAN REPLACED THE CABLE, AND THE DEVICE WAS WORKING FINE NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502115 ↗
• MalfunctionFeb 25, 2026Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS AN EXCESSIVE TEMPERATURE VARIABILITY IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 20FEB2026, NO PATIENT IMPACT REPORTED, NO PATIENT IDENTIFIER AVAILABLE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 20FEB2026, THERE WILL A FIELD SERVICE VISIT EARLY NEXT WEEK TO INVESTIGATE THE ISSUE AND POSSIBLY SOLVE THE ISSUE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444981 ↗
• MalfunctionFeb 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE COULD NOT POWER ON. PER REVIEW OF WORK ORDER ON 25DEC2025, THERE WAS NO PATIENT INVOLVEMENT. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 27JAN2026, IT WAS REPORTED THAT THE TEMPERATURE IN CABLE-NELLCOR WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264583 ↗
• MalfunctionNov 21, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT PER WO EVALUATION, THERE WERE UNRELIABLE CONNECTIONS FOR PCN 73502 IN AN ARCTIC SUN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616738 ↗
• MalfunctionOct 20, 2025Erratic or Intermittent Display; Failure to Sense; Erratic or Intermittent Display; Failure to Sense

  IT WAS REPORTED THAT THE WATER TEMPERATURE WAS NOT REACHING TARGET DUE TO AIR LEAK AT FLUID DELIVERY LINE CONNECTOR TEMPERATURE PROBE SHOWING INTERMITTENT CONNECTION IN AN ARCTIC SUN DEVICE. TESTS SHOWED THE DELIVERY HOSE WAS LEAKING AIR INTO THE SYSTEM THROUGH ONE OF THE CONNECTORS. ADDITIONALLY, THE TEMPERATURE PROBE WAS GIVING INTERMITTENT READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336384 ↗
• MalfunctionSep 16, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE SOUNDED AN ALARM EVERY 10 MINUTES DUE TO LOSS OF CONTROL, IT WAS UNABLE TO MONITOR THE TEMPERATURE. PER REVIEW OF WO ON 15SEP2025, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064612 ↗
• MalfunctionAug 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS LOW FLOW IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 05AUG2025, THERE WAS NO PATIENT INVOLVEMENT. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 19AUG2025, IT WAS REPORTED THAT THE TEMPERATURE IN CABLE-NELLCOR WAS DAMAGED. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 18NOV2025, IT WAS REPORTED THAT THEY NOTED THE HEATER AND MIXING PUMP) HAVE ALSO MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893662 ↗
• MalfunctionAug 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE SCREEN HAD NO DISPLAY. PER SAMPLE EVALUATION RESULTS ON 19AUG2025, TEMPERATURE IN CABLE-NELLCOR WAS DAMAGED. FILL TUBE WAS CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885175 ↗
• MalfunctionJul 17, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT'S TEMPERATURE DID NOT APPEAR ON LCD WINDOW, EVEN THOUGH A NEW TEMPERATURE PROBE CABLE WAS CONNECTED IN AN ARCTIC SUN DEVICE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 16JUL2025, THEY WILL CHECK THE DEVICE ON SITE. TEMPERATURE IN CABLE WAS EXPECTED TO BE A PROBLEM. NOT CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530643 ↗
• MalfunctionJun 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DISPLAY STAYED BLACK IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON 05JUN2025, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 05JUN2025, DEVICE WOULD BE REPAIRED IN THE HOSPITAL BY CRS. THEY WOULD JUST CHANGE THE CONTROL PANEL. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 18JUN2025, IT WAS REPORTED THAT THE TEMPERATURE IN CABLE NELLCOR WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302001 ↗
• MalfunctionJun 11, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT TEMPERATURE WAS NOT REGISTERING CORRECTLY ON ARCTIC SUN DEVICE. AXILLARY & ORAL 36.8C ESOPHAGEAL READING 36.9C ON MONITOR, BUT 33.5C ON THE ARCTIC SUN DEVICE. HAD THEM CHECK CABLE CONNECTIONS AND NO CHANGE NOTED. WHEN FLEX CABLE THE TEMPERATURE JUMPED 2+ DEGREES. ADVISED TO SWAP OUT TEMPERATURE IN CABLE. CONTACT BIOMED IF THEY DON'T HAVE ANOTHER ONE ON THE FLOOR. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 30JUN2025, SPOKE WITH NURSE WHO CONFIRMED THEY EXCHANGED THE CABLE FOR ANOTHER NELLCOR CABLE. THE ORIGINAL CABLE WAS DISPOSED OF WITHOUT EVALUATION. NO FURTHER ISSUES AFTER CABLE EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187002 ↗
• MalfunctionJun 10, 2025Defective Component; Device Sensing Problem; Defective Component; Device Sensing Problem

  IT WAS REPORTED THAT THE ALARM CODE 113 (REDUCED WATER TEMPERATURE CONTROL) AND 64 (NON-RECOVERABLE SYSTEM ERROR) MESSAGES APPEARED ON THE SCREEN DURING THERAPY TODAY. PER REVIEW OF WO ON 29JAN2025, DEVICE WAS USED ON PATIENT. NO PATIENT IDENTIFIERS AVAILABLE, NO PATIENT IMPACT REPORTED. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 10MAR2025, ISSUE RESOLVED ONSITE. PREVENTIVE MAINTENANCE WAS PERFORMED CORRECTLY AND THE DEVICE WORKED CORRECTLY. ALSO, THE TEMPERATURE CABLE NELLCOR HAD TO BE REPLACED. PER ADDITIONAL INFORMATION UPDATED IN WO ON 20MAY2025, IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE, BUT IF MOVED IT, THE TEMPERATURE WOULD INCREASE AND DECREASE A LOT, THEN IT WAS REPLACED, BECAUSE THE MEASURE WAS NOT CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180026 ↗
• MalfunctionMay 12, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT'S TEMPERATURE DID NOT APPEAR ON LCD WINDOW, EVEN THOUGH A NEW TEMPERATURE PROBE CABLE WAS CONNECTED TO ARCTIC SUN DEVICE. AT FIRST, A FOLEY CATHETER WITH TEMPERATURE SENSING CABLE WAS SUSPECTED TO BE DEFECTIVE AND REPLACED WITH A NEW ONE. BUT THE ISSUE WAS NOT RESOLVED. AFTERWARDS, WHEN THEY TRIED TO USE ANOTHER TEMPERATURE CABLE WAS CONNECTED TO THE SAME DEVICE, THE PATIENT'S TEMPERATURE WAS DISPLAYED NORMALLY. THUS, THE TEMPERATURE CABLE THEY USED FIRST MIGHT BE ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003920 ↗
• MalfunctionMar 4, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE TEMPERATURE PROBE WAS NOT READING ACCURATELY AND ARCTIC SUN DEVICE REWARMING VERY SLOWLY. PER REVIEW OF WO ON 03MAR2025, DEVICE WAS USED ON PATIENT AND MOVED TO ANOTHER UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514781 ↗
• MalfunctionFeb 25, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE FSS STATED THAT THEY HAD THE ARCTIC SUN DEVICE WITH A BAD TEMPERATURE CABLE 735-02, GAVE PART NUMBER AND PRICE FOR A NEW ONE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 02APR2025, PER REVIEW OF EVENT AND WORK ORDER, BD REPRESENTATIVE SUCCESSFULLY TROUBLESHOT THE MALFUNCTION DURING THE CALL. THE EVENT CONCLUDED WITH THE DEVICE SUCCESSFULLY TROUBLESHOT WITH TECHNICAL SUPPORT AND APPROPRIATE REPAIR HAS BEEN DISCUSSED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459973 ↗
• MalfunctionFeb 24, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE DISPLAYED AN ERROR CODE DURING OPERATION, IMAGE OF THE CONSOLE CROSSED OUT IN RED. TODAY, THE DEVICE TURNED ON CORRECTLY BUT NO LONGER DETECTS THE PATIENT'S TEMPERATURE. PER REVIEW OF WO ON 19FEB2025, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 19FEB2025, THIS WOULD BE SENT TO S-INTER FOR REPAIR. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 14APR2025, IT WAS REPORTED THAT THERE WAS A DIRTY FILL TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445976 ↗
• MalfunctionApr 1, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TEMPERATURE TARGET DID NOT REACH TO COOL AND TO HEAT . THERE WAS A TEMPERATURE PROBLEM IN COOLING AND REHEATING. PER REVIEW OF WO ON (B)(6) 2024, DEVICE WAS USED ON PATIENT AND THERAPY ENDED MANUALLY. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2024, THE DEVICE WAS SENT IN FOR A BD-APPROVED FACILITY FOR EVALUATION. IN TRANSIT WITH THE CARRIER. REPAIR WAS NOT YET STARTED. WITH ORIGINAL DEVICE USING MANUAL MODE TO REACH TARGETED TEMPERATURE. NO IMPACT TO THE PATIENT. PER INVESTIGATOR NOTIFICATION RECEIVED VIA TASK ON (B)(6) 2024, IT WAS REPORTED THAT THE DURING DEPOT REPAIR FINDINGS, LEVEL SENSOR WAS FOUND CRACKED AND COMPLAINT AGAINST THE TEMPERATURE CABLE (735-02) THAT THE TEMPERATURE CABLE WAS DAMAGED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011677 ↗
• MalfunctionApr 1, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD FLOW ISSUE, PREVENTIVE MAINTENANCE NEEDED. PER SAMPLE EVALUATION RESULTS ON 19MAR2024, IT WAS REPORTED THAT THERE WERE CRACKS ON THE LEVEL SENSOR AND THE TEMPERATURE IN CABLE WAS DAMAGED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010598 ↗
• MalfunctionApr 1, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT POST SUDDEN CARDIAC ARREST PATIENT IN NORMOTHERMIA PROTOCOL. ARCTIC SUN STARTED DIRECTLY WITH MINIMUM WATER TEMPERATURE 22 DEGREE CELSIUS THEN 25 DEGREE CELSIUS , TEMPERATURE TAKEN FROM RELIABLE BLADDER. PATIENT'S TEMPERATURE SET AT 36.5 DEGREE CELSIUS BUT DESPITE THIS, PATIENT LOWERED TO 34.8-35DEGREE CELSIUS BY ARTIC SUN DESPITE GOOD SETTING. MAIN CONNECTION WAS CRACKED AND SENSOR CALIBRATION WAS NEEDED. AS PER INVESTIGATOR NOTIFICATION ON 20MAR2024, IT WAS REPORTED THAT THE TEMPERATURE CABLE ISSUE PER THE DEPOT REPAIR FINDINGS (735-02). DURING THE MAINTENANCE HOSPITEC FIND OUT, THAT THE CABLE DID NOT WORK CORRECTLY, SO THEY REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010597 ↗
• MalfunctionMar 26, 2024Material Fragmentation; Device Sensing Problem; Material Fragmentation; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN TEMPERATURE CABLE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978335 ↗
• MalfunctionMar 11, 2024Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT TEMPERATURE CABLE WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874480 ↗
• MalfunctionMar 5, 2024Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE DID NOT DETECT THE TEMPERATURE PROBE. PER REVIEW OF WO ON 23FEB2024, DEVICE WAS USED ON PATIENT AND NO PATIENT INJURY WAS DETECTED. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 23FEB2024, THE DEVICE WOULD BE REPAIRED ONSITE BY CHANGING THE NELCOR 73502 CABLE. THE ISSUE WAS NOT RESOLVED YET. PER SAMPLE EVALUATION RESULTS ON 06MAR2024, IT WAS REPORTED THAT THE FILL TUBE WAS NOT WORKING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837128 ↗
• MalfunctionFeb 5, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT EMPTYING PADS AND NOT "MEASURING PATIENT TEMPERATURE CORRECTLY ". USER WAS UNINTERESTED IN TROUBLESHOOTING AND REQUESTED A FIELD SERVICE PERSON TO COME ON SITE TO CHECK THE DEVICE OUT. THEY DID POINT OUT IT APPEARED TO HAVE BEEN SERVICED RECENTLY IN OCTOBER 2023 (ABOUT 3 MONTHS AGO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640571 ↗