Arctic Sun® Temperature Management System, ArcticGel™ Pads 31702Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741080029), received between Nov 29, 2021 and Apr 23, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Disconnection

  IT WAS REPORTED THAT THE PICU NURSE STARTING NEW THERAPY AND WAS GETTING ALERT 02 (LOW FLOW). THE ARCTIC SUN DEVICE PRIMED AND STOPPED. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 4777, PUMP HOURS WERE 3058, INLET PRESSURE (IP) WAS -0.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0LPM. AS WE WERE DISCONNECTING THE PADS, THEY NOTICED DAMAGE TO ONE OF THE PAD CONNECTORS. THEY WOULD REPLACE THESE PADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973955 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT THE HYDROGEL LAYER HAD COME AWAY FROM THE ARCTIC GEL PAD, LEAVING THE GEL STUCK TO THE PATIENT'S SKIN. DURING USE, THE PATIENT WAS ROLLED TO CHECK SKIN. THE HYDROGEL LAYER HAD COME OFF AND CONGEALED TO THE PATIENT'S SKIN. THE PADS WERE REMOVED, ANOTHER SET OF PADS WERE OPENED AND NOTICED THAT THE HYDROGEL LAYER WAS COMING OFF THEM TOO. THESE WERE DISPOSED OF. THEY DO NOT YET KNOW IF THEY HAVE A SAMPLE TO RETURN. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 24JUL2025, LOT PROVIDED FOR 2ND SET OF PADS NGJZ2056. THE PADS WERE REMOVED FROM THE PATIENT, AND ANOTHER SET OF PADS WERE OPENED AND APPLIED TO THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036424 ↗
• MalfunctionNov 24, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE TRYING TO INITIATE THERAPY USING ARCTIC SUN DEVICE S/N (B)(6) BUT WERE GETTING A LOW FLOW ALERTALERT 02). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, SYSTEM HOURS 885.5, PUMP HOURS 705.2. HAD NURSE STOP THERAPY, DISCONNECT AND RECONNECT THE PADS, AND RESUME THERAPY. NO IMPROVEMENT. STOPPED THERAPY, EMPTIED AND DISCONNECTED THE PADS. STARTED MANUAL MODE. 1.8LPM, -7.0SPI, 51%. CONNECTED THE RIGHT THIGH PAD. 0.5LPM, -0.3PSI, 100%. DISCONNECTED RIGHT THIGH PAD AND CONNECTED OTHER PADS ONE AT A TIME. RIGHT CHEST 1.2LPM, -6.9LPM, 96%. LEFT CHEST 1.5LPM, -7.1PSI, 46%. LEFT THIGH 2.4LPM, -7.2PSI, 68%. RECONNECTED RIGHT THIGH PAD AND FLOW AND INLET PRESSURE (IP) WAS DROPPED AGAIN, 0.1LPM, -0.6PSI. REMOVED RIGHT THIGH PAD. PATIENT ALSO HAS A UNIVERSAL PAD IN PLACE. CONNECTED UNIVERSAL PAD. 3.4LPM, -7.2PSI, 83%. LOT NGKQ1967. ASKED NURSE TO PUT DAMAGED PAD BEHIND THE NURSE'S STATION. SUGGESTED REPLACING RIGHT THIGH PAD WITH A UNIVERSAL PAD, BUT THEY DO NOT HAVE ANY LEFT. THEY WILL OPEN ANOTHER SET OF PADS. DISABLED MANUAL MODE AND STARTED THERAPY. FLOW RATE WAS 3.3LPM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633399 ↗
• MalfunctionOct 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE GEL PEEL OFF FROM ARCTIC GEL PAD DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369510 ↗
• MalfunctionMay 28, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT WHEN USING NORMAL TEMPERATURE MAINTENANCE MODE, LOW FLOW RATE ALARMS OCCURRED FREQUENTLY IN AN ARCTIC SUN DEVICE. CONNECTED ONLY THE CONFIRMATION LINE TO THE AS5000 MAIN UNIT AND CONFIRMED THAT THERE WAS NO PROBLEM WITH THE FLOW RATE. WHEN A 3S ARCTIC GEL PAD WAS CONNECTED, IT WAS CONFIRMED THAT THE CONSTANT FLOW RATE WAS 1.0 L/MIN OR LESS. TOUCHING THE TUBING CONNECTED TO THE GEL PAD FURTHER REDUCED THE FLOW RATE. IT WAS DETERMINED THAT THE ISSUE WAS CAUSED BY THE PAD. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 03JUN2025, SAMPLE WILL BE SENT TO BD-APPROVED FACILITY FOR EVALUATION. A NEW GEL PAD WAS USED, AND TREATMENT WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095658 ↗
• MalfunctionMay 28, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE 1ST CALL ON MAY 07, NURSE STATED THAT THEY HAVE HAD A PATIENT ON THE ARCTIC SUN DEVICE FOR 9 DAYS. THEY WERE HAVING LOW FLOW ISSUES. WHEN THEY TRIED EMPTYING THE PADS, THE DEVICE WAS ALARMING THAT THE EMPTY PADS CYCLE WAS NOT COMPLETE. NURSE ASKED HOW MANY DAYS COULD THE PADS BE USED BEFORE NEEDING TO BE CHANGED OUT. INFORMED NURSE TO RECOMMEND CHANGING THE ARCTIC GEL PADS AFTER 5 DAYS OF USE, OR AS NEEDED IF SOILED OR DAMAGED. NURSE CONFIRMED THEY HAD EXCEEDED THE 5 DAYS, AND THIS WAS LIKELY WHY THEY WERE NOW SEEING LOW FLOW. NURSE WOULD CHANGE OUT THE PADS AND CALL BACK IF THIS DID NOT FIX THE ISSUE. NO FOLLOW UP PAGE FROM NURSE. 2ND CALL ON 09MAY, PATIENT HAS BEEN ON THERAPY FOR 9 DAYS. PADS HAVE BEEN CHANGED AS DIRECTED IN MANUAL, BUT DEVICE WAS ALERTING AND THERE WAS NO WATER FLOW RATE (WFR). SIZE XXS PADS CONNECTED. WATER FLOW RATE (WFR) WAS 0 L/M, NORMOTHERMIA TARGETED TEMPERATURE (TT) WAS 36C, PATIENT TEMPERATURE (PT) WAS 35.9C. HAD THEM PRESS STOP THERAPY AND EMPTY PADS. DEVICE ALERTED EMPTY PADS NOT COMPLETE X 2. HAD THEM DISCONNECT OVER TRASH CAN. NO WATER NOTED COMING FROM CONNECTORS. PLACED DEVICE IN MANUAL CONTROL AT 30C WITH NO PADS CONNECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404406 ↗
• MalfunctionMar 28, 2024Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE PEELING OF THE STICKY PORTION OF THE ARCTIC GEL PADS WERE NOTED TWICE ON TWO DIFFERENT PATIENTS MONTHS AGO BUT DID NOT AFFECT THERAPY AS NOTED ON THE ARCTIC SUN DEVICE FROM RECOLLECTION OF FEEDBACK. RECENTLY TODAY, A PATIENT USING AN XXS SMALL WAS NOTED TO HAVE A CHEST PAD THAT CONTINUOUSLY HAD THE AUDIBLE SOUND OF WATER RUSHING IN (SIMILAR TO WHEN PADS ARE FIRST CONNECTED AND FILL HOWEVER, THIS WAS CONTINUOUS). IT WAS NOT LEAKING, AND THE PATIENT WAS THERAPEUTIC PER REVIEW OF THE ARCTIC SUN. THEY TRIED DRAINING THE PADS, DISCONNECTING THIS PAD SPECIFICALLY, RECONNECTING AND RESTARTING THERAPY BUT IT DID NOT RESOLVE. THEN CHANGED OUT THE PAD AND THAT RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18992846 ↗
• MalfunctionFeb 8, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THEY TRIED TO MAINTAIN NORMOTHERMIA BUT FLOW RATE WAS 0LPM AND THEY DO NOT SEEN ANY WATER FLOWING THROUGH THE PADS. INLET PRESSURE (IP) WAS -0.8PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. PUMP HOURS WERE 3140. SYSTEM HOURS WERE 3942. ONE XXS PAD IN PLACE. THEY DO NOT TREAT MANY BABIES AND DO NOT HAVE NEONATAL OR SMALL UNIVERSAL PADS. STOPPED THERAPY. CONNECTED A SECOND PAD. RESUMED THERAPY. INLET PRESSURE REMAINED AT -0.6PSI. STOPPED THERAPY AND DISCONNECTED PADS. STARTED IN MANUAL MODE. 1.7LPM, -7.3PSI, 59 PERCENTAGE. CONNECTED THE PAD THAT WAS ON THE 5.5KG PATIENT. 0.3LPM, -7PSI, 26 PERCENTAGE. CONNECTED A SECOND PAD (NOT ON PATIENT). 2LPM, -7PSI, 63 PERCENTAGE. CONNECTED A THIRD PAD (NOT ON PATIENT). 3.2LPM, -7PSI, 71 PERCENTAGE. RESUMED THERAPY, DISABLED MANUAL CONTROL. CONFIRMED HIGH AND LOW WATER LIMITS (10C AND 40C). EXPLAINED HOW SMALL UNIVERSAL AND NEONATAL PADS HAVE A WHITE CLOTH BACKING ON THEM. NURSE TO BE DILIGENT WITH CHECKS AS THE HYDROGEL WAS IN DIRECT CONTACT WITH THE SKIN. NURSE WOULD LIKE TO HAVE NEONATAL AND SU PADS ON HAND FOR WHEN OTHER PEDIATRIC PATIENTS NEED THERAPY. ANSWERED OTHER QUESTIONS ABOUT THE DEVICE INCLUDING WHAT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667297 ↗
• MalfunctionNov 29, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ARCTIC GEL PADS HAD SLOW FLOW RATE AND THERE WERE MANY BUBBLES OBSERVED IN THE WATER FLOW. PER FOLLOW UP INFORMATION RECEIVED ON 12NOV2021, THERAPY WAS COMPLETED USING ANOTHER DEVICE. IT WAS UNKNOWN WHETHER IT WAS AN AIR LEAK ISSUE OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882740 ↗