Arctic Sun StatRecalls & reported problems across all models
Medivance, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Arctic Sun Stat model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,717
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls
- 1
We found 2 models of Arctic Sun Stat by Medivance, Inc. in the FDA's device registry (GUDID). Together they are named in 1,717 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2020 and Sep 26, 2026 — classified as 37 injuries, 1,680 malfunctions.
The most frequently reported specific device problem is “Insufficient Heating” (297 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 Stat 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.
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Arctic Sun Stat problems
Device problems
- Insufficient Heating297
- Device Sensing Problem217
- Inaccurate Flow Rate204
- Defective Component170
- Insufficient Cooling165
- Gas/Air Leak161
- Computer Operating System Problem146
- Circuit Failure116
Patient problems
- No Clinical Signs, Symptoms or Conditions1,580
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available117
- Chills33
- Convulsion/Seizure3
- No Code Available3
- Fever2
- Insufficient Information1
- No Consequences Or Impact To Patient1
Arctic Sun Stat models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arctic Sun Stat 60000000System, thermal regulating1 recall1,613 reports
- Arctic Sun Stat 60000000LSystem, thermal regulating1 recall104 reports
Recent Arctic Sun Stat adverse event reports
The 15 most recent reports across all models, 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 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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