Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector 73552Recalls & reported problems
Medivance, Inc. · Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741080340), received between Aug 3, 2022 and Sep 4, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem2
- Fitting Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH TEMPERATURE TRANSMISSION FROM ARCTIC SUN DEVICE TO MONITOR. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 03SEP2025, DEVICE WOULD BE REPAIRED IN THE HOSPITAL BY CRS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965948 ↗MalfunctionSep 4, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE PROBLEMS WITH TEMPERATURE TRANSMISSION FROM ARCTIC SUN DEVICE TO MONITOR. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 03SEP2025, DEVICE WOULD BE REPAIRED IN THE HOSPITAL BY CRS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963529 ↗MalfunctionOct 28, 2022Fitting Problem; Fitting Problem
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE THERE WAS LOOSE CONTACT IN TEMPERATURE OUT CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15693012 ↗MalfunctionAug 3, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN SENSOR CALIBRATION WAS PERFORMED, THE DEVICE FAILED CALIBRATION FOR AN ERROR 105 (NON RECOVERABLE NAVIGATION ERROR). BIOMED STATED THAT THE EXPECTED VALUE WAS 128.1 BUT THE ACTUAL VALUE WAS 130. PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2022, THE TEMPERATURE OUT CABLE AND THE POWER CORD WERE FOUND TO HAVE PROTECTIVE INSULATION DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15155801 ↗
Other System, thermal regulating devices
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- 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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