Level 1 H-1100-ES-115VRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Level 1 (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50695085828264), received between Aug 12, 2020 and Feb 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Alarm” (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.
Reports received per month
Most reported problems
Device problems
- False Alarm1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2024False Alarm; False Alarm
IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY ALARMED FOR THE DISPOSABLES. AFTER TRYING DIFFERENT SETS, THE ALARM WAS MANUALLY ENGAGED BUT WOULD NOT CLEAR. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18703006 ↗MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS POLE DID NOT GO DOWN AND THE DEVICE HAD CORRODED BOARD. NO REPORTED ADVERSE EFFECTS.
Patient problems: No Information
MAUDE report 10396744 ↗
Other Warmer, thermal, infusion fluid devices
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
- 3-Spike Disposable Set (1 Piece) 903-00006PBelmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall1 death97 reports
- Rapid Infuser RI-2, 120V, 750 ml/min 903-00039Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid132 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Rapid Infuser RI-2, 120V, 1000ml/min 903-00037Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 death76 reports
- Hyperthermia Pump Procedure Kit 902-00045Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall4 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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