Arctic Sun® Temperature Management System, Temperature Cable Phono 73505Recalls & reported problems
Medivance, Inc. · Arctic Sun® Temperature Management System, Temperature Cable Phono · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741080326), received between Jul 22, 2022 and Apr 4, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
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
Device problems
- Device Sensing Problem1
- Disconnection1
- Material Fragmentation1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2023Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE TEMPERATURE WAS FLUCTUATING ON THE ARCTIC SUN DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16673340 ↗MalfunctionJul 22, 2022Disconnection; Material Fragmentation; Disconnection; Material Fragmentation
IT WAS REPORTED THAT THE PATIENT'S TEMPERATURE SUDDENLY STOPPED BEING DISPLAYED WHILE USING ARCTIC SUN-5000 FOR COOLING. WHEN THE TEMPERATURE PROBE CONNECTION CABLE WAS SHAKEN, THE BODY TEMPERATURE WAS DISPLAYED. THEREFORE IT WAS DETERMINED THAT THE CONNECTION CABLE WAS DISCONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15083984 ↗
Other System, thermal regulating devices
- Arctic Sun® 5000 50000000Medivance, Inc. · System, thermal regulating1 recall3 deaths6,903 reports
- Arctic Sun® 5000 50000000EMedivance, Inc. · System, thermal regulating1 recall2 deaths4,413 reports
- Arctic Sun Stat 60000000Medivance, Inc. · System, thermal regulating1 recall1,613 reports
- Arctic Sun® 5000 50000000LMedivance, Inc. · System, thermal regulating1 recall388 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31802Medivance, Inc. · System, thermal regulating1 recall385 reports
- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
- Arctic Sun Stat 60000000LMedivance, Inc. · System, thermal regulating1 recall104 reports
- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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