Arctic Sun® 5000 50000000ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4,413 adverse event reports that list this exact device (DI 00801741127755), received between Jun 29, 2017 and Sep 29, 2026 — classified as 2 deaths, 271 injuries, 4,140 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (705 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 4,413 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Insufficient Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940858 ↗
• MalfunctionSep 29, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940519 ↗
• MalfunctionSep 28, 2026Restricted Flow rate

  It was reported that biomed stated Arctic Sun device would not fill and had no suction.Per WO notes, failed circulation pumps no suction at left port during filling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916291 ↗
• MalfunctionSep 25, 2026Insufficient Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904197 ↗
• MalfunctionSep 25, 2026No Display/Image

  It was reported that the biomed called to state that the Arctic Sun device was not able to get a reading from Patient Outlet Monitor Temperature with the temperature simulator. They stated they had tried different temperature in cables and felt confident it was not an issue with the temperature in cable.Per WO Notes, they discussed this was indicative of an issue with the isolation circuit card and provided part number and price.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900322 ↗
• MalfunctionSep 25, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899371 ↗
• MalfunctionSep 23, 2026Inaccurate Flow Rate

  It was reported that IQVIA technician was onsite and the Arctic Sun device was not cooling. Per sample evaluation, it was reported that in Arctic Sun device the tank seals were found to not be sealing properly. The lower bearing of the circulation pump was dried out. The flow meter was found to have low readings during post repair functional testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873288 ↗
• MalfunctionSep 17, 2026Failure to Pump; Calibration Problem

  It was reported that biomed requested a new quote for 2000-hour service and calibration error 80.Per WO notes circulation pump was failed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802957 ↗
• MalfunctionJul 28, 2026Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059472 ↗
• MalfunctionJul 21, 2026Failure to Pump; Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884695 ↗
• MalfunctionJul 19, 2026Inaccurate Flow Rate; Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25867783 ↗
• MalfunctionJul 19, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25867756 ↗
• MalfunctionJul 14, 2026Failure to Pump; Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820582 ↗
• MalfunctionJul 13, 2026Restricted Flow rate; Failure to Pump

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25795804 ↗
• MalfunctionJul 10, 2026Failure to Pump; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787517 ↗
• MalfunctionJun 26, 2026Failure to Pump

  IT WAS REPORTED THAT THE NURSES SENT THE ARCTIC SUN DEVICE DUE TO PADS NOT FILLING, BIOMED WAS NOT SURE IF THEY WERE HAVING ANY OTHER ISSUES SUCH AS LOW FLOW. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 14APR2026, SPOKE WITH BIOMED WHO STATED THEY HAD ALREADY SPOKEN WITH TECHNICAL SUPPORT REGARDING THIS ISSUE. THEY DENIED ANY ISSUES WITH DETECTING WATER LEVEL, BUT THE DEVICE WAS HAVING ISSUES WITH THE WATER FLOW RATE LEVEL. THE DEVICE WILL BE REPAIRED BY BD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641983 ↗
• MalfunctionJun 19, 2026Failure to Pump

  IT WAS REPORTED THAT THE BIOMED HAD AN ARCTIC SUN DEVICE THAT WAS NOT FILLING, THEY COULD HEAR THE PUMP BUT NO SUCTION ON THE LEFT PORT. PER ADDITIONAL INFORMATION RECEIVED VIA TTM ON 17APR2026, BIOMED STATED DEVICE WAS NOT FILLING. HAD REMOVE SHUNT TUBE FROM FLUID DELIVERY LINE (FDL) AND TRY AGAIN. STILL NOT TAKING WATER AND DID NOT HEAR THE PUMP ENGAGE. BIOMED WANTED A QUOTE FOR SENDING IN S/N (B)(6) FOR REPAIR, DEVICE WOULD NOT FILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566056 ↗
• MalfunctionJun 17, 2026Failure to Pump

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS SHOWING -5.5-6.2. PER ADDITIONAL INFORMATION RECEIVED VIA TTM ON 28MAY2026, BIOMED WAS DOING PREVENTIVE MAINTENANCE PROCEDURE. CHECKING FLUID DELIVERY LINE (FDL) AND INLET PRESSURE (IP) WAS REGISTERING AT -5.5 TO -6.7PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540994 ↗
• MalfunctionJun 10, 2026Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT NURSE STATES THEY ARE UNABLE TO START THERAPY AS THE PROBE IS NOT READING A PATIENT TEMPERATURE. THERE ARE DASHES WHERE THIS INFORMATION SHOULD BE. MOVED THE RECTAL PROBE TO THE BEDSIDE AND CONFIRMED IT IS READING PROPERLY. THE NURSE TURNED THE DEVICE OFF THINKING THIS WOULD HELP AND WHEN IT POWERED BACK ON THE SCREEN WAS BLACK. CONFIRMED THE DEVICE IS PLUGGED INTO A MEDICAL GRADE WALL OUTLET AND THE BUTTON ON THE BACK IS ILLUMINATED. ADVISED THIS DEVICE WILL NEED TO GO TO BIOMED. PER FOLLOW UP INFORMATION RECEIVED ON 04JUN2026, THE BIOMED CONNECTED A NEW CABLE, THEY DID NOT SEE ANY OBVIOUS DEFECTS WITH THE FIRST CABLE BUT STATED THAT SWAPPING THEM RESOLVED THE ISSUE. THEY HAD REBOOTED THE DEVICE TWICE AND DEVICE POWERED ON. THEY RAN A VERIFICATION CHECK, AND IT SEEMED TO WORK FINE. THEY WILL BE RETURNING IT TO SERVICE. ADDITIONAL INFORMATION WILL BE ADDED TO THE RECORD IF AND WHEN ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25463749 ↗
• MalfunctionJun 9, 2026Inaccurate Flow Rate; Failure to Pump

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS SENT TO THE BIOMED SHOP FOR LOW FLOW. IN BYPASS MODE, THE CIRCULATION PUMP COMMAND (CPC) WAS AT 63 PERCENTAGE. PER WO NOTES, THEY DISCUSSED THIS WAS INDICATIVE OF A FAILED CIRCULATION PUMP AND REQUESTED AN EMAIL WITH PRICING OPTIONS TO DISCUSS WITH MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446094 ↗
• MalfunctionJun 5, 2026Failure to Pump; Calibration Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FAILED CALIBRATION FOR ERROR 3 (PRE WARM NOMINAL FLOW ERROR) AND WOULD NOT FILL AFTER BEING DRAINED. PER WO NOTES, THE CIRCULATION PUMP HAS FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411072 ↗
• MalfunctionJun 4, 2026Failure to Pump; Calibration Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FAILED CALIBRATION ERROR 80 (WATER CHECK TIME OUT - UNABLE TO REACH CALIBRATION TEMPERATURE). EXPECTED VALUE WAS 6, ACTUAL VALUE WAS 30. PER WO NOTES, DURING TESTING THE DEVICE WOULD NOT COOL. CHILLER TEMPERATURE (T4) WAS 3.9, MIXING PUMP COMMAND (MPC) WAS 100 PERCENTAGE. FAILED MIXING PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399146 ↗
• MalfunctionJun 4, 2026Nonstandard Device

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ISSUED A RED SCREEN UPON STARTUP AND A MESSAGE TO REBOOT THE DEVICE. PER REVIEW OF WO NOTES, BIOMED WILL CHECK THE CONNECTION BETWEEN CONTROL PANEL AND PROCESSOR CARDS AND CALL BACK IF THE ISSUE REMAINS. BIOMED CALLED BACK AND WALKED THEM THROUGH CHECKING THE COMMUNICATION CONNECTOR AND THEY SAID THEY HAD ALREADY RESEATED THE CIRCUIT BOARDS AND ISSUE WAS STILL OCCURRING, THEY EXPLAINED IT WOULD NEED TO COME IN TO GET THE ROOT CAUSE FIGURED OUT BECAUSE IT COULD BE ONE OF MULTIPLE PARTS, THEY ASKED WHAT PARTS AND HUNG UP AFTER THEY WENT OVER THE PARTS, THEY DECLINED THE QUOTE. PER ADDITIONAL INFORMATION RECEIVED VIA TTM ON 16MAR2026, NURSE STATED THEY WERE GETTING A RED SCREEN WITH MESSAGE. SYSTEM FAILED TO START. POWER DOWN THEN POWERS UP TO RETRY. CONTACT MEDIVANCE. NURSE CONFIRMED THEY HAVE ALREADY TRIED REBOOTING A COUPLE OF TIMES AND THE MESSAGE KEPT RETURNING. ADVISED TO SEND TO BIOMED SO THAT THEY COULD CALL BACK AND SPEAK WITH ENGINEERS FOR ADDITIONAL SUPPORT. PER SAMPLE EVALUATION RESULTS ON 12MAY2026, POWER CIRCUIT CARD CONTRIBUTED TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392315 ↗
• MalfunctionJun 1, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE IQVIA TECHNICIAN WAS ONSITE TO PERFORM THE FIELD ACTION. THIS ARCTIC SUN DEVICE HAD NO FLOW, AND THE CIRCULATION PUMP WAS UNABLE TO GENERATE PRESSURE GREATER THAN NEGATIVE 0.1 PSI. PER WO NOTES, VERIFIED FLUID DELIVERY LINE (FDL) CONNECTION WITH NO DAMAGE. DISCUSSED WOULD SEND QUOTE FOR 2000 HOUR SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352607 ↗
• MalfunctionMay 28, 2026Failure to Pump; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED DOING A FUNCTIONAL CHECK IN AN ARCTIC SUN DEVICE, WATER FLOW RATE (WFR) WAS 2.7 L/MIN, INLET PRESSURE (IP) WAS -3PSI WITH ONE SHUNT LOOP CONNECTED. BIOMED WAS GETTING A CALIBRATION ERROR 1 (PRE-WARM BYPASS FLOW ERROR) WITH ACTUAL VALUE OF 2995. BIOMED PROVIDED S/N (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321959 ↗