Arctic Sun 5000Recalls & reported problems across all models
Medivance, Inc. · 3 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 5000 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11,704
- Deaths reported
- 5
- Injuries reported
- 680
- Recalls
- 1
We found 3 models of Arctic Sun 5000 by Medivance, Inc. in the FDA's device registry (GUDID). Together they are named in 11,704 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Sep 29, 2026 — classified as 5 deaths, 680 injuries, 11,019 malfunctions.
The most frequently reported specific device problem is “Insufficient Cooling” (2,047 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 5000 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 3 of these models · Recall details · FDA record ↗
Most reported Arctic Sun 5000 problems
Device problems
- Insufficient Cooling2,047
- Defective Component1,976
- Failure to Pump1,591
- Device Sensing Problem1,380
- Insufficient Heating1,065
- Gas/Air Leak873
- Temperature Problem862
- Restricted Flow rate859
Patient problems
- No Clinical Signs, Symptoms or Conditions7,438
- No Known Impact Or Consequence To Patient2,311
- No Consequences Or Impact To Patient2,119
- No Patient Involvement1,275
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available788
- Alteration In Body Temperature481
- Patient Problem/Medical Problem329
- Chills160
Arctic Sun 5000 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arctic Sun® 5000 50000000System, thermal regulating1 recall3 deaths6,903 reports
- Arctic Sun® 5000 50000000ESystem, thermal regulating1 recall2 deaths4,413 reports
- Arctic Sun® 5000 50000000LSystem, thermal regulating1 recall388 reports
Recent Arctic Sun 5000 adverse event reports
The 15 most recent reports across all models, 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 28, 2026Failure to Pump
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916262 ↗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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873291 ↗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 ↗MalfunctionSep 17, 2026Failure to Pump; Calibration Problem
It was reported biomed stated that Arctic Sun device was failed calibration error 1.Per WO notes circulation pump was failing (CPC- 66 percentage).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802950 ↗MalfunctionJul 30, 2026Insufficient Cooling
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084497 ↗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 ↗
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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