Arctic Sun® Temperature Management System, ArcticGel™ Pads 31801Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741080128), received between Dec 21, 2022 and Jul 30, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (5 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.

• MalfunctionJul 30, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085795 ↗
• MalfunctionFeb 27, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ALERTING 02 LOW FLOW. PATIENT TEMPERATURE (PT) WAS 98.2F, TARGETED TEMPERATURE (TT) WAS 98.6F, WATER TEMPERATURE (WT) WAS 66.6F, WATER FLOW RATE (WFR) WAS 0.9 L/M. 1 SMALL UNIVERSAL PAD CONNECTED TO 8 KILO PEDIATRIC PATIENT. NURSE STATED THEY ARE VERY SMALL AND THERE WAS NO ROOM FOR A SECOND PAD. HAD STOP THERAPY, EMPTY AND DISCONNECT PAD. RECONNECTED USING PROPER TECHNIQUE. RESTARTED THERAPY AND WATER FLOW RATE (WFR) WAS STABILIZED AT 0.2 L/M AND WOULD NOT INCREASE. HAD STOP THERAPY, EMPTY AND DISCONNECT. PLACED DEVICE IN MANUAL CONTROL AT 75F WITH NO PADS CONNECTED. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 64.2F, OUTLET CONTROL TEMPERATURE (T2) WAS 64.5F, INLET TEMPERATURE (T3) WAS 65.7F, CHILLER TEMPERATURE (T4) WAS 44.2F, WATER FLOW RATE (WFR) WAS 1.7 L/M, INLET PRESSURE (IP) WAS -7PSI CIRCULATION PUMP COMMAND (CPC) WAS 49 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER WAS 53, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 7439 AND PUMP HOURS WERE 4700.3. WALKED THROUGH DISABLING MANUAL CONTROL. RECONNECTED PADS AND AGAIN WATER FLOW RATE (WFR) WOULD NOT RISE ABOVE 0.2 L/M. ADVISED TO SWAP OUT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475128 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE REPORTING TWO EVENTS WITH ARCTIC SUN DEVICE 318-01. HYDROGEL PULLED FROM PAD WHEN ATTEMPTING TO REMOVE LINER DURING PREPARATION FOR PATIENT USE ON (B)(6) 2025. BOTH PADS AVAILABLE FOR RETURN. LOT NGJX2716 AND LOT NGHY1330.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771321 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE REPORTING TWO EVENTS WITH ARCTIC SUN DEVICE 318-01. HYDROGEL PULLED FROM PAD WHEN ATTEMPTING TO REMOVE LINER DURING PREPARATION FOR PATIENT USE ON (B)(6) 2025. BOTH PADS AVAILABLE FOR RETURN. LOT NGJX2716 AND LOT NGHY1330.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771017 ↗
• MalfunctionJul 8, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT ANOTHER COMPANY'S LABEL WAS AFFIXED TO THEIR LEGAL DISPLAY LABEL. THE HOSPITAL USED ONE SET OF LOT NUMBER: 31702 AND ONE SHEET OF LOT NUMBER: 3180104 ADDITIONAL GENERAL-PURPOSE S, BUT THERE WAS A DEFECT IN 3180104, SO THEY USED THE OTHER ONE. WHEN REPORTED THIS TO IMI, THE IMI SALES REPRESENTATIVE RECALLED ONE OF THE DEFECTIVE 3180104 SHEETS. IMI REPORTED A COMPLAINT TO BD ON 19MAY ABOUT 31801 AND DID NOT PROVIDE ANY DETAILED INFORMATION. IMI PURCHASING CONTACTED TO REQUEST A REVIEW OF THE RETURN OF 31801, AND THAT IF IT WAS NOT POSSIBLE TO RETURN IT, IMI WOULD TAKE APART 3180104 AND PROVIDE IT TO CUSTOMERS. ON 30MAY, IMI MARKETING CONTACTED THEM REGARDING THE RETURN OF 31801. ON (B)(6), THE IN CHARGE VISITED US TO CHECK WHETHER IT WAS REUSED AND TO SEE IF IT WAS DEFECTIVE. WHEN THEY CHECKED WITH THE HOSPITAL AND FOUND THAT THE PROBLEM WAS WITH ONE OF THE 3180104 PADS, AND IMI BROUGHT A DIFFERENT SIZE PAD AS A REPLACEMENT. THE HOSPITAL SENT ANOTHER PHOTO OF THE OVER LABEL ON 11JUN. IT WAS INITIALLY REPORTED AS A PROBLEM WITH THE PAD, BUT AN OVER LABEL WAS DISCOVERED. LEGAL, E&C, AND QA REPORTS COMPLETED. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 02JUL2025,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436482 ↗
• MalfunctionJun 16, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE TRYING TO COOL A BABY USING ARCTIC SUN DEVICE S/N (B)(6), BUT THE PATIENT WAS NOT COOLING. THEY GOT AN ALERT ABOUT THE BABY NOT GETTING TO TARGET. TARGETED TEMPERATURE (TT) WAS 33.5C. PATIENT TEMPERATURE (PT) WAS 34.5C. THE WATER WAS IN THE 20S. THEY CHANGED TO S/N (B)(6). THE WATER WAS GETTING COLDER (12C), BUT THEY WERE GETTING LOW FLOW. PATIENT TEMPERATURE (PT) WAS 34.6C, WATER TEMPERATURE (WT) WAS 11.9C, FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 13 PERCENTAGE, PUMP HOURS WERE 867.9 AND SYSTEM HOURS WERE 926.6. CV 0. EMPTIED AND DISCONNECTED PADS. MANUAL FLOW RATE (FR) WAS 1.2LPM, INLET PRESSURE (IP) WAS -6.8PSI, CIRCULATION PUMP COMMAND (CPC) WAS 36 PERCENTAGE. REMOVED FLUID DELIVERY LINE (FDL), COVERED PORTS. FLOW RATE (FR) WAS 1.1LPM, INLET PRESSURE (IP) WAS -7.2PSI. ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) IN (B)(6) EVENT LOG. CHANGED PAD LAST NIGHT BECAUSE BABY NOT COOLING. GOT (B)(6) FROM THE PICU. ADJUSTED SETTINGS TO MATCH PROTOCOL. CONNECTED PAD (NGJZ1088). FLOW RATE (FR) WAS 0.1LPM, INLET PRESSURE (IP) WAS -6.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 37 PERCENTAGE. PAD GOING THROUGH G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213191 ↗
• MalfunctionMay 19, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT WHEN TREATMENT WAS STARTED USING TWO ADDITIONAL GENERAL-PURPOSE SMALL ARCTIC GEL PADS, ALARMS 01 AND 02 OCCURRED FREQUENTLY. THE ARCTIC SUN DEVICE ITSELF WAS SUSPECTED AND REPLACED WITH ANOTHER DEVICE IN THE HOSPITAL, BUT THIS DID NOT CHANGE ANYTHING. THE ALARMS STOPPED WHEN THE PAD WAS REPLACED WITH ONE PAD. SINCE BLISTERS WERE FOUND ON THE TIP OF THE PAD, IT WAS DETERMINED THAT THE PAD WAS DEFECTIVE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Blister

  MAUDE report 22047776 ↗
• MalfunctionMay 19, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT WHEN TREATMENT WAS STARTED USING TWO ADDITIONAL GENERAL-PURPOSE SMALL ARCTIC GEL PADS, ALARMS 01 AND 02 OCCURRED FREQUENTLY. THE ARCTIC SUN DEVICE ITSELF WAS SUSPECTED AND REPLACED WITH ANOTHER DEVICE IN THE HOSPITAL, BUT THIS DID NOT CHANGE ANYTHING. THE ALARMS STOPPED WHEN THE PAD WAS REPLACED WITH ONE PAD. SINCE BLISTERS WERE FOUND ON THE TIP OF THE PAD, IT WAS DETERMINED THAT THE PAD WAS DEFECTIVE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047768 ↗
• MalfunctionMar 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LOW TEMPERATURE PATCH LEAKAGE HAD OCCURRED IN AN ARCTIC GEL PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607518 ↗
• MalfunctionDec 9, 2024Gas/Air Leak; Patient Device Interaction Problem; Gas/Air Leak; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE ARCTIC GEL PAD LEAK VELOCITY WAS LOW.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877862 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAKAGE IMMEDIATELY AFTER OPENING AND USE OF AN ARCTIC GEL PAD. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 09DEC2024, THE DEVICE WAS SENT IN FOR A BD-APPROVED FACILITY FOR EVALUATION. THE ISSUE WAS NOT RESOLVED. NEW ONE WAS USED. PATIENT COMPLETE THERAPY ON THE NEW DEVICE. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851860 ↗
• MalfunctionApr 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THEY NOTED THE PAD ISSUE BELOW. THE PATIENT WAS SET FOR A TEMPERATURE OF 33C FOR 24HRS AND WAS CURRENTLY BEING REWARMED, USING PAD SIZE SMALL UNIVERSAL; LOT # NGGZ1389.THEY DID NOT NOTE ANY GEL ON THE PATIENT¿S SKIN IN THIS INSTANCE AND THE PAD APPEARS TO BE FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095291 ↗
• MalfunctionDec 21, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT CURRENTLY ON ARCTIC SUN DEVICE WITH ONE SMALL UNIVERSAL PAD CONNECTED. WEIGHT OF PATIENT WAS TOO SMALL FOR XXS PADS WHICH WAS THE SMALLEST SIZE THEY CURRENTLY HAVE. PATIENT HAS BEEN ON THERAPY FOR 5 DAYS NOW. IT WAS MAINTAINING TEMPERATURE AND COOLING THE PATIENT, BUT THE LAST 2 DAYS PATIENT DID NOT SEEM TO BE COOLING. PATIENT WEIGHT 12 KILOGRAMS. BEEN ALERTING LOW FLOW. MIS EXPLAINED FOR PATIENT WEIGHT RECOMMENDED PAD APPLICATION WOULD BE 3 SMALL UNIVERSAL PADS. WRAP 2 PADS LOOSELY AROUND CHEST AND ABDOMEN. ADD A THIRD PAD AROUND THE LEGS. NURSE STATED THEY HAVE NO MORE UNIVERSAL SMALL PADS. FLOW RATE WAS 0.4 LPM. MIS DISCUSSED IMPORTANCE OF FLOW RATE FOR FUNCTIONALITY. NURSE HAS A SET OF XXS ARCTIC GEL PADS NURSE WOULD CONNECT TO BOOST FLOW RATE. EMAILED PEDIATRIC PAD SIZE QRGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16029274 ↗