Arctic Sun Temperature Management System, ArcticGel PadsRecalls & reported problems across all models
Medivance, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Arctic Sun Temperature Management System, ArcticGel Pads model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 703
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 1
We found 8 models of Arctic Sun Temperature Management System, ArcticGel Pads by Medivance, Inc. in the FDA's device registry (GUDID). Together they are named in 703 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2020 and Sep 29, 2026 — classified as 25 injuries, 678 malfunctions.
The most frequently reported specific device problem is “Inaccurate Flow Rate” (291 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Arctic Sun Temperature Management System, ArcticGel Pads recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 16, 2024Class IIOpen, Classified
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
Z-1381-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Arctic Sun Temperature Management System, ArcticGel Pads problems
Device problems
- Inaccurate Flow Rate291
- Gas/Air Leak106
- Fluid/Blood Leak53
- Material Separation52
- Deformation Due to Compressive Stress48
- Restricted Flow rate41
- Patient Device Interaction Problem26
- Loss of or Failure to Bond19
Patient problems
- No Clinical Signs, Symptoms or Conditions651
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available26
- No Consequences Or Impact To Patient7
- Skin Discoloration6
- Pressure Sore/Ulcer5
- Blister4
- Burn(s)4
- Localized Skin Lesion4
Arctic Sun Temperature Management System, ArcticGel Pads models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31802System, thermal regulating1 recall385 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31705System, thermal regulating90 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31707System, thermal regulating90 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31709System, thermal regulating79 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31700System, thermal regulating24 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31703System, thermal regulating13 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31801System, thermal regulating13 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31702System, thermal regulating9 reports
Recent Arctic Sun Temperature Management System, ArcticGel Pads adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940522 ↗MalfunctionSep 26, 2026Inaccurate Flow Rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908457 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889816 ↗InjurySep 11, 2026Patient Device Interaction Problem
Patient problems: Localized Skin Lesion; Skin Discoloration
MAUDE report 50741618 ↗MalfunctionJul 31, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100485 ↗MalfunctionJul 30, 2026Inaccurate Flow Rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085795 ↗MalfunctionJul 27, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022353 ↗MalfunctionJul 27, 2026Inaccurate Flow Rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022125 ↗MalfunctionJul 7, 2026Device Sensing Problem
IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT A NURSE STATED THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM DID NOT SUCCESSFULLY CONTROL PATIENT TEMPERATURE BY ACHIEVING AND MAINTAINING PATIENT TO TARGET TEMPERATURE BECAUSE "FAULTY PAD, REPLACED AND TEMPERATURE CONTROL WAS ACHIEVED" IN RELATION TO "ARCTIC SUN 5000" AND PADS "NEONATAL". ADDITIONALLY, IN THE ONLINE SURVEY, IN CHART 6 A NURSE STATED THAT NO, THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM DID NOT SUCCESSFULLY MONITOR THE PATIENT'S TEMPERATURE THROUGHOUT THERAPY BECAUSE "FAULTY PAD" IN RELATION TO "ARCTIC SUN 5000" AND PADS "NEONATAL".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25739075 ↗InjuryJul 2, 2026Patient Device Interaction Problem
IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT A NURSE STATED THAT THE PATIENT EXPERIENCED OTHER ASSOCIATED ADVERSE EVENTS, LOCALIZED SKIN EFFECTS THERMAL DERMATITIS, HYDROGEL RELATED SKIN IRRITATION, PRESSURE RELATED INJURIES. SKIN IRRITATION, SKIN TEARS UNDER PADS. PATIENT SHIVERING, AND THE MEDICAL INTERVENTION WAS MEDICATION ADMINISTRATION INCREASED SEDATION, BAIR HUGGER PLACED ON TOP OF PATIENT WHILE COOLING, MAGNESIUM ADMINISTRATION. WHILE USING ARCTIC SUN 5000 WITH PADS SMALL (S). THE PATIENT DID HAVE DIABETES, PERIPHERAL VASCULAR DISEASE OR POOR NUTRITIONAL STATUS. THE PATIENT WAS ON STEROIDS OR HIGH DOSE VASOPRESSOR THERAPY.
Patient problems: Chills; Skin Tears
MAUDE report 25691306 ↗MalfunctionJul 2, 2026Patient Device Interaction Problem
IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT A NURSE STATED THAT AN ADVERSE EVENT WAS EXPERIENCED AS A RESULT OF THE CHAIR SESSION, THIS BEING, NONE WHILE USING ARCTIC SUN 5000 WITH PADS LARGE (L). ADDITIONALLY, A NURSE STATED THAT THE PATIENT EXPERIENCED OTHER ASSOCIATED ADVERSE EVENTS, PATIENT SHIVERING, AND THE MEDICAL INTERVENTION WAS COLD BATH. WHILE USING ARCTIC SUN 5000 WITH PADS NEONATAL. ADDITIONALLY, A NURSE STATED THAT THE PATIENT EXPERIENCED OTHER ASSOCIATED ADVERSE EVENTS, PATIENT SHIVERING, AND THE MEDICAL INTERVENTION WAS, COLD BATH. WHILE USING ARCTIC SUN 5000 WITH PADS LARGE (L). ADDITIONALLY, A NURSE STATED THAT AN ADVERSE EVENT WAS EXPERIENCED AS A RESULT OF THE CHAIR SESSION, THIS BEING, PRESSURE ULCER WHILE USING ARCTIC SUN 5000 WITH PADS SMALL (S).
Patient problems: Chills
MAUDE report 25689703 ↗MalfunctionJun 26, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT THE ARCTIC SUN DEVICE GETTING AN ALARM THAT THE PATIENT CANNOT REACH GOAL TEMPERATURE. THEY SHOULD BE AT TARGET AT 825PM, BUT THE BABY WAS STILL 35.3C. THE WATER TEMPERATURE HAS BEEN DECREASING, CURRENTLY 36C. THEY HAVE AN ALARM 113 (REDUCED WATER TEMPERATURE CONTROL) IN THE EVENT LOG. THE FLOW WAS 0.5LPM, INLET PRESSURE WAS -6.9PSI, CIRCULATION PUMP COMMAND WAS 39 PERCENTAGE. PUMP HOURS WERE 1182.5. SYSTEM HOURS WERE 3209. THE REWARM OCCURS FROM 36.3C AT 0.5C/HR TO 36.5C. ASKED NURSE TO FEEL/LOOK FOR ANY KINKS, TWIST, COMPRESSION OR OCCLUSION OF THE PAD TUBING. UNABLE TO IDENTIFY ANY. THE NURSE DISCONNECTED THE PAD, ROTATED THE CONNECTORS AND RECONNECTED THE PAD USING PROPER TECHNIQUE. FLOW REMAINED LOW AT 0.6LPM. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON (B)(6) 2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PAD HAD BEEN EXCHANGED FOR A NEW ONE, AND FLOW RATE WENT UP SIGNIFICANTLY. THE WATER TEMPERATURE ALSO ROSE SO THE PATIENT WAS ABLE TO REACH THE TARGET TEMPERATURE AND MAINTAIN UNTIL THERAPY COMPLETED. THE ORIGINAL PAD HAD BEEN DISCARDED WITH BIOHAZARDOUS WASTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641982 ↗MalfunctionJun 25, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT ARCTIC SUN DEVICE IS ALARMING LOW FLOW (ALARM 02) AND THERAPY HAS SHUT OFF. THEY CHANGED THE ORIENTATION OF THE TUBING. THE NURSE STATED THE FLOW DROPPED TO 0 LPM, SO GOING TO CHANGE THE PAD OUT. NURSE STATED THAT THE FLOW WAS 0 LPM, INLET PRESSURE WAS -7PSI, CIRCULATION PUMP COMMAND WAS 34 PERCENTAGE. THE FLOW WAS 1.8 LPM, -7.3PSI, 73 PERCENTAGE. PUMP HOURS WERE 1263. SYSTEM HOURS WERE 4480. FLOW DROPPED TO 1.1 LPM AND INLET PRESSURE WAS -7.8 PSI. THERE WAS ALARM 113 (REDUCED WATER TEMPERATURE CONTROL) IN THE EVENT LOG. NURSE CONFIRMED THAT PADS WERE CONNECTED PROPERLY AND MOVED THE TUBING AROUND. THE FLOW WAS 0.8LPM, -7.1PSI. IF THE FLOW DROPPED TO 0.5LPM, THE HEATER WOULD NOT BE ABLE TO WORK APPROPRIATELY, LEADING TO ALARM 113. WALKED THE NURSE THROUGH REPLACING THE PAD. THE FLOW WITH NEW PAD WAS 0.9 LPM, -7.3PSI, 33 PERCENTAGE. NURSE REMOVED THE FLUID DELIVERY LINE AND INLET PRESSURE DROPPED TO 0 LPM. REPLACED THE FLUID DELIVERY LINE 0.9 LPM, -7PSI, 36 PERCENTAGE. ASKED THE NURSE TO KEEP AN EYE OF FLOW RATE AND TO CALL BACK IF IT DROPS AGAIN. PER FOLLOW UP INFORMATION RECEIVED ON 22JUN2026, NURSE STATED THAT THE FLOW HAD DROPPED BACK DOWN TO ZERO AGAIN. THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630814 ↗InjuryJun 16, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT HARD MATERIAL IN THE ARCTIC GEL PAD THAT EASILY CAUSES PRESSURE SORES IN THE ARMPITS.
Patient problems: Pressure Sore/Ulcer; Ulcer
MAUDE report 25522333 ↗MalfunctionJun 1, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT THEY WERE TRYING TO INITIATE THERAPY BUT KEEP GETTING AIR LEAK AND NO FLOW IN AN ARCTIC SUN DEVICE. NURSE NOTED THAT THE ARCTIC GEL PAD LINE OR TUBING WAS NOT FULLY CONNECTED AT THE CLAMP. ADVISED SWAPPING OUT TO A NEW SET OF PADS. AIR OPENINGS IN THE LINE WOULD AFFECT THE FLOW RATE. PLACE THESE PADS ASIDE AND THE TM WILL FOLLOW UP AND ASSIST WITH HAVING THEM RETURNED FOR INVESTIGATION. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 28MAY2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PADS ARE IN OFFICE. THEY DID NOT HAVE ANY DETAILS REGARDING THE PATIENT EVENT AND NOTED THEY HAD SPOKEN WITH THEIR REPRESENTATIVE ABOUT THE PAD AND WAS TOLD TO KEEP IT UNTIL SOMEONE CALLS TO COLLECT IT OR THE REPRESENTATIVE PICKS IT UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356254 ↗
Other Medivance, Inc. products
All Medivance, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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