Arctic Sun Stat 60000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,613 adverse event reports that list this exact device (DI 00801741161513), received between Jan 12, 2021 and Sep 26, 2026 — classified as 35 injuries, 1,578 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (284 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 27, 2024Open, Classified

   If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

   Z-2457-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,613 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908452 ↗
• MalfunctionSep 26, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908450 ↗
• MalfunctionSep 25, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903549 ↗
• MalfunctionSep 25, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903548 ↗
• MalfunctionSep 25, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902835 ↗
• InjurySep 25, 2026Lack of Effect

  It was reported that patient was on therapy for a few days. The patient's temperature was high (38.2C). The water temperature was continuously cold (4-5 C). Now the patient's skin was turning red where the pads touch. Currently patient temperature was 38.2C, water temperature was 4.6C, Flow rate was 2.6lpm. There was a good pad coverage. Asked the nurse to treat generation per facility protocol. Discussed the benefits of counter warming and suggested speaking with the Health Care Professionals to determine if therapy should be paused or stopped after assessing skin.

  Patient problems: Skin Discoloration

  MAUDE report 50899373 ↗
• MalfunctionSep 18, 2026Insufficient Cooling; Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828917 ↗
• MalfunctionSep 11, 2026Insufficient Heating

  It was reported that the biomed stated the Arctic Sun device was not warming the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739295 ↗
• MalfunctionAug 6, 2026Insufficient Heating; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164210 ↗
• MalfunctionJul 27, 2026Circuit Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50026511 ↗
• MalfunctionJul 27, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022164 ↗
• MalfunctionJul 21, 2026Circuit Failure; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25895197 ↗
• MalfunctionJul 15, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25826317 ↗
• MalfunctionJul 14, 2026Insufficient Heating

  IT WAS REPORTED THAT NURSE WAS TRYING TO WARM THE PATIENT, BUT THE WATER TEMPERATURE WAS NOT RESPONDING IN ARCTIC SUN DEVICE. THE PATIENT TEMPERATURE WAS 36C, TARGET TEMPERATURE WAS 38C, WATER TEMPERATURE WAS 27.8C, FLOW RATE WAS 2.9LPM. CONFIRMED NORMOTHERMIA CASE, THE RATE SET TO 0.25C. DEVICE HAD ONLY BEEN RUNNING FOR ABOUT ONE HOUR, SO THE GRAPH DID NOT REVEAL VERY MUCH INFORMATION. THE NURSE ELECTED TO CHANGE THE RATE TO 0.5C. NO ALERTS OR ALARMS. THE NURSE WILL CALL BACK IF THE PATIENT TEMPERATURE DOES NOT RESPOND APPROPRIATELY, OR IF THERE ARE ANY ALERTS/ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820581 ↗
• MalfunctionJul 13, 2026Insufficient Cooling; Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807630 ↗
• MalfunctionJul 10, 2026Insufficient Heating; Overfill

  IT WAS REPORTED THAT THE NURSE STATED THEY WERE HAVING A LOT OF ISSUES WITH THE PATIENT GETTING TO TARGET, SO THEY ARE SWAPPING THE ARCTIC SUN DEVICE OUT. THE ORIGINAL TARGET WAS 36.5C, BUT PATIENT DROPPED TO 36C. THEY CHANGED THE TARGET TO 37C, AND PATIENT DROPPED EVEN FURTHER TO 35.5C. NOW THE PATIENT WAS VERY COLD (33C), AND THEY WERE SETTING UP A NEW DEVICE ((b)(6)). GUIDED TO HYPOTHERMIA SCREEN ON NEW DEVICE. CONFIRMED THIS DEVICE NOT BORROWED FROM AN ADULT UNIT. PATIENT WAS 32.8C AT THIS TIME. CHECKED REWARM SETTINGS TO CONFIRM FROM 33C, RATE 0.5C PER HOUR, TARGET WAS 37C. STARTED THERAPY ON REWARM SIDE AND FLOW RATE (FR) WAS SETTLED AT 1.1LPM. FOLLOW UP CALL FOR CASE (b)(4). PATIENT WAS NOW 34.1C (T1 RECTAL) AND DEVICE HAS STOPPED SEVERAL TIMES. WATER TEMPERATURE (WT) WAS 25.6C, FLOW RATE (FR) WAS 2.7LPM, TARGETED TEMPERATURE (TT) WAS 37C, T2 (FOLEY) READING 34.5C. REWARM TAB READS FROM 34.1C, RATE 0.5C PER HOUR, TO 37C. ADVISED THIS LOOKS GREAT BUT CLAIMED CHANGED THIS BECAUSE IT WAS READING 37C AND THEY THOUGHT THIS IS WHY THE DEVICE KEPT STOPPING. CHECKED EVENT LOG AND NOTED ALARM 14 (PROBE OUT OF RANGE), ALERT 113 (REDUCED WATER TEMPERATURE CONTROL), AND ALERT 114 (THERA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788710 ↗
• MalfunctionJul 10, 2026Inaccurate Flow Rate; Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788442 ↗
• MalfunctionJul 10, 2026Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE BIOMED STATED THEY RECENTLY GOT THE ARCTIC SUN DEVICE REPAIRED AND RETURNED TO FLOOR. IT WAS WITH THE PATIENT NOW AND ALERTING 113 (REDUCED WATER TEMPERATURE CONTROL) EVERY THIRTY MINUTES. THE PATIENT TEMPERATURE WAS 37.6C, TARGET TEMPERATURE WAS 37C, WATER TEMPERATURE WAS 33.3C, FLOW RATE WAS 2.9LPM, CHILLER TEMPERATURE WAS 4C, MIXING PUMP COMMAND WAS 100PERCENTAGE. CONFIRMED THEY HAVE BEEN GETTING ALERT 113 (REDUCED WATER TEMPERATURE CONTROL). EXPLAINED THAT THE DEVICE NEEDS TO BE SERVICED AND THEY SHOULD CHANGE TO ANOTHER DEVICE. TRANSFERRED BIOMED FOR FURTHER TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786727 ↗
• MalfunctionJul 10, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT REACHED THE 36C TARGET THAT MORNING BUT WENT ABOVE THE TARGET. THE ARCTIC SUN DEVICE DID NOT BRING THE TEMPERATURE DOWN, SO THE NURSE ADDED ICE PACKS. NOW THE TARGET WAS 37C AND SHE WAS UP TO 37.5C. SHE WAS DOING ROUNDS AND CALLED BACK AT 7PM WHEN SHE COULD BE IN THE ROOM. THE TARGET WAS 37C AND PATIENT WAS 37.9C. WATER TEMPERATURE WAS 5.4C. FLOW WAS 2.4LPM. EXPLAINED THE DEVICE WAS RESPONDING APPROPRIATELY AND SUGGESTED LOOKING INTO PATIENT FACTORS. NURSE CONFIRMED THERE WAS EXPOSED ABDOMEN. SUGGESTED ADDING A UNIVERSAL PAD. NURSE DENIES ANY INFECTION, SHIVERING OR SEIZURES. DISCUSSED BENEFITS OF COUNTER WARMING. ASKED NURSE TO PERFORM DILIGENT SKIN CHECKS AND TO TREAT HEAT GENERATION PER FACILITY PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786376 ↗
• MalfunctionJun 16, 2026Insufficient Heating

  IT WAS REPORTED THAT THE DURING REWARMING IN NORMOTHERMIA. PATIENT HAS BEEN ON THERAPY SINCE 9AM IN AN ARCTIC SUN DEVICE. CLINICAL STAFF ADVISING BIOMED THAT THE PATIENT TEMPERATURE (PT) AND WATER TEMPERATURE (WT) HAS NOT BEEN INCREASING THIS ENTIRE TIME. PATIENT TEMPERATURE (PT) WAS 35.5C, TARGETED TEMPERATURE (TT) WAS 37C, WATER TEMPERATURE (WT) WAS 29.5C, WATER FLOW RATE (WFR) WAS 3.1 L/M. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 29.8C, OUTLET CONTROL TEMPERATURE (T2) WAS 29.7C, INLET TEMPERATURE (T3) WAS 29.5C, CHILLER TEMPERATURE (T4) WAS 4C, WATER FLOW RATE (WFR) WAS 3.1 L/M, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 70 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER WAS 6 PERCENTAGE, WATER RESERVOIR LEVEL (WRL) WAS 3, SYSTEM HOURS WERE 104.3 AND PUMP HOURS WERE 60.8. WALKED THROUGH STOP THERAPY AND WALKED THROUGH SETTING UP REWARMING IN HYPOTHERMIA. REWARM FROM 35.5C AT 0.25C/HR TO 37C. RESTARTED THERAPY AND WATER FLOW RATE (WFR) WAS STABILIZED AT 3.2 L/M. ADVISED THEY WILL CALL BACK IN 30 MINUTES TO CHECK IN AND CONFIRM IF WATER TEMPERATURE (WT) HAS INCREASED INTO THE 30S. BIOMED ADVISED THAT WATER TEMPERATURE (WT) W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527326 ↗
• MalfunctionJun 16, 2026Failure to Pump

  IT WAS REPORTED THAT THE BIOMED HAD THE ARCTIC SUN DEVICE THAT WASN'T PASSING CALIBRATION FOR AN ERROR 5 INLET PRESSURE OUT OF RANGE. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 12MAY2026, BIOMED HAD DEVICE FAILING CALIBRATION. CALIBRATION ERROR 5 (GIVEN A VALUE OF NEGATIVE 192). SN: (B)(6). BIOMED STATED THEY WERE SPEAKING WITH THEM EARLIER ABOUT DEVICE FAILING CALIBRATION. WAS WAITING ON A RETURN CALL BUT HASN'T RECEIVED IT YET. PER REVIEW OF WO NOTES, AFTER RUNNING THE DEVICE WITH THE CTU IT APPEARS TO BE GETTING PROPER INLET PRESSURE NOW NEGATIVE 7.0 BUT EXPLAINED THAT THE ISSUE MIGHT BE A WEAK CIRCULATION PUMP WHEN IT FIRST STARTS UP SINCE THE DEVICE HAS 2904 SYSTEM HOURS AND NO RECORD OF THE 2000 HOUR PM EVER BEING DONE, WRITING THEM A QUOTE FOR THE 2000 HOUR PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523301 ↗
• MalfunctionJun 11, 2026Decreased Pump Speed

  IT WAS REPORTED THAT THE CUSTOMER STATED THE ARCTIC SUN DEVICE WOULD NOT FILL AND FEELS THIS WAS DUE TO A FAILED CIRCULATION PUMP. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 18MAY2026, IT WAS REPORTED THAT THE TWO TANK GASKETS WORN AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473316 ↗
• MalfunctionJun 8, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE BIOMED STATED THEY HAVE ARCTIC SUN DEVICE WITH A NOTE THAT SAYS, TEMPERATURE CARD WAS DEFECT. THE TEMPERATURE PROBES WERE NOT READING FOR THE NURSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437694 ↗
• MalfunctionJun 5, 2026Inaccurate Flow Rate; Failure to Pump

  IT WAS REPORTED THAT THEY JUST STARTED COOLING AND WERE GETTING A LOW FLOW ALARM (ALARM 02) IN AN ARCTIC SUN DEVICE. DIRECTED NURSE TO THE SYSTEM DIAGNOSTICS. FLOW RATE (FR) WAS 1LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 28 PERCENTAGE. EXPLAINED FLOW AND INLET PRESSURE (IP) ARE WITHIN SPECIFICATION NOW. THEY DEVICE MIGHT HAVE BEEN TAKING LONGER THAN NORMAL TO PRIME EARLIER. THERAPY CONTINUED. THEY WERE GETTING A LOW FLOW ALARM ON DEVICE AGAIN. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 5 PERCENTAGE. THEY HAVE CHECK FOR KINKS AND CONFIRMED THE PAD IS CONNECTED PROPERLY. ASKED NURSE TO EMPTY PADS. NURSE RECEIVED ALARM 07 (EMPTY PAD CYCLE NOT COMPLETE). DISCONNECTED PAD. PLACED DEVICE IN MANUAL MODE. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -6.7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE. CV 1. PUMP HOURS WERE 186.7 AND SYSTEM HOURS WERE 2676.3. ASKED NURSE TO SEND DEVICE TO BIOMED AND CHANGE TO ANOTHER DEVICE. DESCRIBED HOW TO ADJUST THE COOLING DURATION ON THE NEW DEVICE TO MATCH WHERE THEY ARE IN THERAPY. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 29MAY2026, SPOKE WITH BIOMED WHO C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410142 ↗
• MalfunctionJun 5, 2026Power Problem

  IT WAS REPORTED THAT THE BIOMED HAD AN ARCTIC SUN DEVICE THAT WAS ON A PATIENT. IT SUDDENLY LOST POWER AND THEY REPLACED IT WITH A NEW DEVICE. THEY WOULD NEED THIS DEVICE OVER THE WEEKEND. CONFIRMED THE DEVICE WAS PLUGGED INTO A MEDICAL GRADE WALL OUTLET. THEY ALREADY HAD THE DEVICE POWERED ON AND WAS TESTING IT IN MANUAL CONTROL AND WAS ABLE TO CONFIRM THE DEVICE REACHED 40C. SUGGESTED TESTING THE WATER AT 4C ALSO AND COULD ALSO CALIBRATE THE DEVICE AND CONFIRM IT PASSES IN CASE THEY NEED IT OVER THE WEEKEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408173 ↗