Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line 73490Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741080289), received between Dec 30, 2022 and Sep 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THEY WERE TRYING TO INITIATE THERAPY USING ARCTIC SUN DEVICE BUT WERE GETTING ALERT 02 (LOW FLOW). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.4PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, PUMP HOURS WERE 5528, SYSTEM HOURS WERE 6456. HAD NURSE STOP THERAPY, EMPTY PADS, AND DISCONNECT PADS. PLACED DEVICE IN MANUAL MODE, WITH ONLY THE FLUID DELIVERY LINE (FDL) ATTACHED, FLOW RATE (FR) WAS 1.8LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 74 PERCENTAGE. CONNECTED LEFT THIGH PAD, FLOW RATE (FR) WAS 2.1LPM, INLET PRESSURE (IP) WAS -4.6PSI. MOVED LEFT THIGH PAD TO ANOTHER VALVE SET, FLOW RATE (FR) WAS 0.8LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 45 PERCENTAGE. CONNECTED LEFT CHEST PAD, NURSE MISTAKENLY ATTACHED IT TO THE FIRST VALVE SET LOCATION THEY CONNECTED THE LEFT THIGH PAD TO AT FIRST. 0.1LPM, -0.7PSI. MOVED TO THE OTHER VALVE SET ON THAT SIDE OF THE FLUID DELIVERY LINE (FDL), FLOW RATE (FR) WAS 1.8LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 68 PERCENTAGE. CONNECTED RIGHT THIGH PAD, 2.4LPM, -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 84 PERCENTAGE. CONNECTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148264 ↗
• MalfunctionJan 30, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT WHEN ARCTIC SUN DEVICE WAS CHECKED TO BE DELIVERED, THERE WAS A BURR LEFT IN THE BUTTON OF THE ATTACHED STRAP KIT AND THE FASTENER DID NOT FIT. PER ADDITIONAL INFORMATION RECEIVED VIA FOLLOW-UP ON 25-JAN-2023, IT WAS REPORTED THAT ISSUE WOULD BE RESOLVED BY REPLACING IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264310 ↗
• MalfunctionDec 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE STRAP KIT FOR THE FLUID DELIVERY LINE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077939 ↗