Level 1 SW-2003Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30695085000031), received between Aug 29, 2017 and Aug 29, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 other recall cover devices cleared under the same FDA submission (K011907); they may or may not involve this specific model.
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
- Improper or Incorrect Procedure or Method1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A PATIENT SUSTAINED A FIRST DEGREE BURN ON THE LEFT FOREARM WITH THE USE OF A LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS. THIS WAS AFTER 4 HOURS AND 30 MINUTES OF USE OF THE DEVICE. THE PATIENT WAS POSITIONED IN A SUPINE POSITION WITH THE ARMS CROSSED. THE OPERATING TEMPERATURE WAS 40 DEGREES CELSIUS. CLINICIANS ENSURED THAT THE INSTALLATION WAS NON-COMPRESSIVE. NO OTHER ADVERSE HEALTH OUTCOMES WERE REPORTED.
Patient problems: Superficial (First Degree) Burn
MAUDE report 6828192 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K011907. One submission often covers many models, so check the product and lot details in each record.
- Z-0497-05 · Dec 15, 2004 · TerminatedEquator Forced Air Convective Warming System, Reference Number EQ 5000
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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