Level 1 SWU-2013Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Level 1 (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586043413), received between Aug 10, 2022 and Sep 6, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inadequate User Interface” (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 16, 2026.
Most reported problems
Device problems
- Inadequate User Interface1
- Mechanical Problem1
Patient problems
- Burn(s)1
- Hemorrhage/Blood Loss/Bleeding1
- Low White Blood Cell Count1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A DEVICE MALFUNCTIONED [UNSPECIFIED] AND A PATIENT EXPERIENCED BURN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Burn(s)
MAUDE report 15360977 ↗InjuryAug 10, 2022Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT THE PATIENT WAS BLEEDING FROM NECK, ANESTHETIC HAD COVERED WITH A PRESSURE DRESSING. PATIENT'S HGB DROPPED FROM APPROXIMATELY 147 TO APPROXIMATELY 76. AT THE END OF THE CASE, AS DRAPES WERE REMOVED, IT WAS NOTED THAT THE BOTTOM CHAMBER OF THE UNDERBODY SNUGGLE WARMER ON THE PATIENTS RIGHT SIDE WAS FULL OF BLOOD, WAS JUST REACHING THE LEVEL WHERE IT WAS STARTING TO SPURT OUT OF THE AIR HOLES. IT WAS THEN NOTED THAT THE NECK HAD BEEN BLEEDING THROUGHOUT THE PROCEDURE-PRESSURE DRESSING SOPPING WET, BLOOD DRIPPED DOWN BLEEDING THE NECK AND INTO THE WARMING BLANKET. INTERVENTION REQUIRED TRANSFUSIONS OF BLOOD TO THE PATIENT TO COMBAT THE DROPPED HGB IN THE OR, BUT WAS FINE POST OP. REPORTER INDICATED THEY HAD DID NOT EXPECT THIS AS A POSSIBILITY AND WANTED TO MAKE THE REPORTING MANUFACTURER AWARE, ALTHOUGH THEY DO NOT ALLEGE THE DEVICE WORKED IMPROPERLY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low White Blood Cell Count
MAUDE report 15201856 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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