Arctic Sun® Temperature Management System, ArcticGel™ Pads 31703Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741080043), received between Nov 9, 2021 and Jan 13, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE STATED THEY HAS BEEN TRYING TO START THERAPY, BUT THE ARCTIC SUN DEVICES JUST PRIME AND STOP. THEY HAD TRIED THREE DIFFERENT DEVICES ALREADY (SN# (B)(6). HAD THEM PROPERLY CONNECT THE PADS TO THE FIRST DEVICE (B)(6). PRESSED START AND GUIDED TO DIAGNOSTICS: SYSTEM HOURS 6256, PUMP HOURS 4904, INLET PRESSURE -0.2, CIRCULATION PUMP COMMAND 100%, FLOW RATE WAS 0LPM (STOPPED). TRIED SECOND DEVICE (B)(6): SYSTEM HOURS 4838, PUMP HOURS 3939, INLET PRESSURE WAS -0.5PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, FLOW RATE WAS 0LPM. THEY HAD ALREADY BEEN TROUBLESHOOTING FOR OVER AN HOUR AT THIS POINT, SO THEY OPTED TO TRY A NEW SET OF PADS (OLD PADS (B)(6). CALLED BACK 30 MINUTES LATER AND CONFIRMED NEW PADS WORKING WITH FLOW RATE OF 3LPM. QUALITY CAN CALL THEM TOMORROW AT THE NUMBER LISTED TO ARRANGE RETURN AS THEY WERE WORKING CHARGE DURING THE DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063333 ↗
• MalfunctionNov 3, 2025Inaccurate Flow Rate; Material Split, Cut or Torn; Inaccurate Flow Rate; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER STARTING USE ON THE PATIENT, THE ARCTIC SUN'S WATER FLOW WAS LOW, AND AN ALARM WAS TRIGGERED. UPON CHECKING, A CRACK IN THE UPPER BODY PAD WAS FOUND, REVEALING A LARGE NUMBER OF AIR BUBBLES, SO AN ARCTIC GEL PAD FROM STOCK WAS USED TO RESOLVE THE ISSUE. THE INCIDENT OCCURRED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453442 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE ULCER ON THE SIDE OF THE ABDOMEN, WOULD CAUSE RELATED TO ARCTIC GEL PADS. DURING USE AFTER A FEW HOURS USING THE THERAPY, THEY REALIZED THE PATIENT HAD A FEW BLISTERS ON THE SIDE OF THE ABDOMEN. IT HAS DEVELOPED OVER THE NEXT 2 WEEKS TO BE A GRADE III ULCER. IT WAS BELIEVED TO BE INFECTED AS THE PATIENT'S ABDOMEN WAS STILL OPEN AND FLUIDS COMING OUT OF THE ABDOMEN WOUND AND INTO THIS SMALLER ONE. THEY TOLD ME THEY USED ONLY ONE PAD IN THE THORACIC AREA, COVERING MOST OF THE BACK AND ONE SIDE WHERE THE BLISTERS APPEARED. THEY ALSO USED BOTH LEG PADS WITH NO ADVERSE REACTIONS THERE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 03APR2025, IT WAS SUSPECTED THAT THE ULCER WAS CAUSED BY THE GEL PADS. SILVER HYDROFIBRE (AQUACEL AG) MEDICATION WAS PROVIDED. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 14JUL2025, IT WAS REPORTED THAT THE HYDROGEL WAS PEELED BACK FROM THE CORNER OF THE RIGHT CHEST PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512843 ↗
• InjuryMar 27, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ULCER ON THE SIDE OF THE ABDOMEN CAUSE RELATED TO PADS DURING USE. AFTER A FEW HOURS USING THE THERAPY, THEY REALIZED THE PATIENT HAD A FEW BLISTERS ON THE SIDE OF THE ABDOMEN. IT HAS DEVELOPED OVER THE NEXT 2 WEEKS TO BE A GRADE III ULCER. IT IS BELIEVED TO BE INFECTED AS THE PATIENT'S ABDOMEN IS STILL OPEN AND FLUIDS COMING OUT OF THE ABDOMEN WOUND AND INTO THIS SMALLER ONE. THEY TOLD ME THEY USED ONLY ONE PAD IN THE THORACIC AREA, COVERING MOST OF THE BACK AND ONE SIDE (WHERE THE BLISTERS APPEARED. THEY ALSO USED BOTH LEG PADS WITH NO ADVERSE REACTIONS THERE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blister; Pressure Sore/Ulcer

  MAUDE report 21712810 ↗
• MalfunctionJan 2, 2025Deformation Due to Compressive Stress; Gas/Air Leak; Deformation Due to Compressive Stress; Gas/Air Leak

  IT WAS REPORTED THAT ALARM 01 (PATIENT LINE OPEN) OCCURRED THAT THE ARCTIC SUN GEL PAD LINE WAS EXPOSED TO THE AIR, SO AFTER CHECKING WITH SERVICE, CUSTOMER REPLACED THE ARCTIC SUN GEL PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054392 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DURING USE, THE AREA AROUND THE BACK ARCTIC GEL PAD WAS WET AND WATER LEAKAGE FROM THE PAD WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846810 ↗
• MalfunctionSep 11, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE DURING THE REWARMING PHASE, ARCTIC SUN DEVICE FLOW RATE WAS DECREASED BELOW 0.2-0.3 L/MIN. CUSTOMER DID EMPTY PADS SEVERAL TIMES, RECONNECTED ALL FOUR PADS AND CHECKED ANY LEAKAGE FROM PADS. BUT THE FLOW RATE DID NOT GO UP AND THE ALARM NUMBER 01 WENT OFF. AFTER ALL THE CUSTOMER'S EFFORT, THEY CHANGED ARCTIC GEL PADS, AND THE FLOW RATE WAS MAINTAINED AS 1.8-1.9L/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191356 ↗
• MalfunctionSep 5, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING THE REWARMING PHASE, ARCTIC SUN DEVICE FLOW RATE WAS DECREASED BELOW 0.2-0.3L/MIN. CUSTOMER DID EMPTY PADS SEVERAL TIMES, RECONNECTED ALL FOUR PADS AND CHECKED ANY LEAKAGE FROM PADS. BUT THE FLOW RATE DID NOT GO UP AND THE ALARM NUMBER 01 (PATIENT LINE OPEN) WENT OFF. AFTER ALL THE CUSTOMER'S EFFORT, THEY CHANGED GEL PADS AND THE FLOW RATE WAS MAINTAINED AS 1.8-1.9L/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147642 ↗
• MalfunctionNov 22, 2023Fitting Problem; Defective Component; Fitting Problem; Defective Component

  IT WAS REPORTED THAT THE GEL PAD COULD NOT BE CONNECTED TO THE MAIN UNIT ON THE ARCTIC SUN DEVICE. IT WAS HARD AND DID NOT FIT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194236 ↗
• MalfunctionOct 21, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE USER STARTED USING THE AS5000 IN THE NORMAL TEMPERATURE MAINTENANCE MODE, BUT THE FLOW RATE WAS 0 AND THE CIRCULATING WATER WAS NOT FLOWING. THEY CHECKED THE STATUS OF THE INDICATIONS THROUGH ON-SITE VISITS. THE USER SUSPECTED SOMETHING WAS WRONG WITH THE AS5000 MAIN UNIT, SO THEY SWITCHED TO THE REPLACEMENT AS5000 THAT THEY BROUGHT JUST IN CASE, BUT THE SYMPTOMS DID NOT IMPROVE. SINCE THE ISSUE WAS NOT CAUSED BY THE MAIN UNIT, THE USER CHECKED THE GEL PADS AND THE HOSE WAS FOUND TO BE BROKEN ON ONE OF THE GEL PADS. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 12SEP2022, STATED THAT THE DEVICE WAS USED TO THE PATIENT AND COMPLETED THERAPY. PER SAMPLE EVALUATION RESULTS RECEIVED ON 12OCT2022, STATED THAT KINKED TUBING WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650891 ↗
• MalfunctionAug 30, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE USER STARTED USING THE AS5000 IN THE NORMAL TEMPERATURE MAINTENANCE MODE, BUT THE FLOW RATE WAS 0 AND THE CIRCULATING WATER WAS NOT FLOWING. THEY CHECKED THE STATUS OF THE INDICATIONS THROUGH ON-SITE VISITS. THE USER SUSPECTED SOMETHING WAS WRONG WITH THE AS5000 MAIN UNIT, SO THEY SWITCHED TO THE REPLACEMENT AS5000 THAT THEY BROUGHT JUST IN CASE, BUT THE SYMPTOMS DID NOT IMPROVE. SINCE THE ISSUE WAS NOT CAUSED BY THE MAIN UNIT, THE USER CHECKED THE GEL PADS AND THE HOSE WAS FOUND TO BE BROKEN ON ONE OF THE GEL PADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321681 ↗
• MalfunctionJul 5, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO USE THE ARCTIC GEL PAD ON THE PATIENT, IT DID NOT CIRCULATE WATER. IT WAS STATED THAT NO PROBLEM WAS FOUND ON THE ARTIC SUN DEVICE (AS5000) AND WHEN THE GEL PAD WAS REPLACED, NORMAL OPERATION WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917213 ↗
• MalfunctionNov 9, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT WENT BACK FROM A FOLLOW-UP MRI CHECK, AND THEN HCP RESTARTED AND RECONNECTED THE ARCTIC GEL PADS TO THE ARCTICSUN5000 DEVICE. THEN SUDDENLY AS5000'S FLOW RATE WAS DISPLAYED AT 0.0 L/MIN WITH LOW FLOW ALARMS. THE CUSTOMER EMPTIED THE PADS SEVERAL TIMES, RECONNECTED ALL FOUR PADS, AND CHECKED FOR ANY BREAKAGES FROM THE PADS. THE CUSTOMER ALSO CONFIRMED THAT THE ARCTIC GEL PADS WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779753 ↗