Level 1 SWU-2003Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586043345), received between May 23, 2018 and Apr 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Gas/Air Leak1
- Material Split, Cut or Torn1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
- Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WAS A WRONG REFERENCE LABEL/ WRONG COMPONENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927391 ↗MalfunctionOct 11, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT A PATIENT WHO WAS TO UNDERGO SURGERY UNDER GENERAL ANESTHESIA AND WAS AT RISK OF HYPOTHERMIA HAD A WARMING BLANKET WITH ACTIVE HEATING USING A WARM AIR BLOWER. IT WAS DISCOVERED THAT THE WARMING BLANKET WAS TORN AT A WELDED SEAM, AND WARM AIR WAS LEAKING OUT. SINCE THE AREA WAS STERILE, IT WAS NOT POSSIBLE TO CHANGE AN ENTIRE BLANKET DURING AN ONGOING OPERATION. THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433202 ↗MalfunctionMay 23, 2018Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE PATIENT SUSTAINED BURNS AND BLISTERS (PHLYCTENE) FOLLOWING USE OF THE EQUATOR WARMING BLANKET. THE EQUATOR HEATED TO 48 DEGREES INSTEAD OF HEATING TO 44 DEGREES. THE DEVICE HAD TO BE CHANGED. WITH THE CURRENT INFORMATION AVAILABLE IT IS NOT CLEAR WHETHER ANY TREATMENT WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.
Patient problems: Burn(s); Injury
MAUDE report 7537115 ↗
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- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
- Arctic Sun Stat 60000000LMedivance, Inc. · System, thermal regulating1 recall104 reports
- Hillrom powered by Augustine Surgical HD 2083516Augustine 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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