Level 1 H-1129Recalls & 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
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 50695085812904), received between Jan 25, 2019 and Nov 20, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Defective Component2
- Infusion or Flow Problem2
- No Audible Alarm2
- Temperature Problem2
- Blocked Connection1
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Information5
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Insufficient Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025No Audible Alarm; No Audible Alarm
IT WAS STATED THAT THERE WAS NO AUDIBLE ALARM FOR OVER TEMP WHEN THEY FILLED THE SOLUTION TANK AND PUT ON TESTER AND THE EVENT OCCURRED DURING TESTING. THERE ARE NO PATIENT INVOLVEMENT AND ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23609871 ↗MalfunctionSep 9, 2025Break; Blocked Connection; Break; Blocked Connection
IT WAS REPORTED THAT THE FLUID DRAIN VALVE WAS BROKEN AT BOTTOM OF UNIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003825 ↗MalfunctionMay 1, 2025Temperature Problem; Noise, Audible; Temperature Problem; Noise, Audible
IT WAS REPORTED THAT THE DEVICE WAS INCONSISTENT, NEITHER INCREASING NOR DECREASING. IT ALSO MAKES A LOUD SOUND. THE EVENT OCCURRED DURING INFUSION. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942156 ↗MalfunctionDec 5, 2024Unexpected Shutdown; Key or Button Unresponsive/not Working; Unexpected Shutdown; Key or Button Unresponsive/not Working
IT WAS REPORTED, THAT THE SYSTEM SHUT OFF, WHILE RUNNING. AND COULD NOT BE TURNED BACK ON. THE ON/OFF BUTTONS ARE NOT WORKING PROPERLY. THERE WAS UNKNOWN, PATIENT INVOLVEMENT. AND UNKNOWN, PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20853956 ↗MalfunctionJun 19, 2024Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE DEVICE PRESSURE WAS NOT MATCHING THE GAUGE AND IT WAS GOING HIGH INTO THE RED; THE ELECTRICAL SAFETY WAS NOT PASSING. THE ISSUE WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566817 ↗MalfunctionJun 5, 2024Defective Alarm; Failure to Pump; Defective Alarm; Failure to Pump
IT WAS REPORTED THAT THE DEVICE WAS NOT RE-CIRCULATING THE FLUIDS AND THE ALARMS WERE NOT WORKING. THE EVENT OCCURRED DURING TESTING AND NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472694 ↗MalfunctionMay 9, 2023Leak/Splash; Power Conditioning Problem; Leak/Splash; Power Conditioning Problem
IT WAS REPORTED THAT THE UNIT WAS "TRIPPING" THE ELECTRICAL BOX IN THE OPERATING ROOM WHEN IT WAS POWERED ON AT THE START OF A PROCEDURE. IT WAS ALSO DISCOVERED THE UNIT HAD A "PUDDLE" UNDERNEATH IT WHEN THE PROBLEM WAS INVESTIGATED. NO ADVERSE EFFECTS REPORTED.
Patient problems: Insufficient Information
MAUDE report 16899307 ↗MalfunctionOct 20, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE DEVICE HAD A STICKY NEEDLE ON THE PRESSURE GAUGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638279 ↗MalfunctionOct 20, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE DEVICE HAD A BAD ACTUATOR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638193 ↗MalfunctionOct 20, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE POWER POLE WAS NOT RISING WITH WEIGHT ON IT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638137 ↗MalfunctionJun 27, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE POLE WILL NOT RAISE AND PHYSICAL DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14827795 ↗MalfunctionMay 26, 2022Power Problem; Power Problem
IT WAS REPORTED THAT THE BUTTON WAS NOT GOING UP AND DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14518989 ↗MalfunctionNov 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A SMITHS MEDICAL FLUID WARMER PORT LABELED ONE WAS SPOUTING OUT WATER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 10827000 ↗MalfunctionSep 18, 2020Electrical Power Problem; Electrical Power Problem
NO PATIENT INVOLVEMENT.
Patient problems: No Information; No Patient Involvement
MAUDE report 10552516 ↗MalfunctionMay 17, 2020Temperature Problem; Temperature Problem
INFORMATION WAS RECEIVED INDICATING THAT THE LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 SERIES WAS OVERHEATING. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Information
MAUDE report 10064064 ↗MalfunctionMar 11, 2020Device Alarm System; Crack; Leak/Splash; Device Alarm System; Crack; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT ERROR CODES WERE DISPLAYED TO A SMITHS MEDICAL LEVEL 1® NORMOFLO® IRRIGATING FLUID WARMING SYSTEM. IT WAS ALSO REPORTED THAT THERE WAS FLUID ON THE MAIN BOARDS. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Information
MAUDE report 9821036 ↗MalfunctionDec 31, 2019Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 WARMER REQUIRED ACTUATOR REPAIR. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information; No Patient Involvement
MAUDE report 9536241 ↗MalfunctionApr 20, 2019Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL NORMOFLO FLUID WARMING DEVICE, IRRIGATING SYSTEM WAS LEAKING WATER, CUSTOMER SUSPECTS BAD COMPRESSOR. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8534287 ↗MalfunctionJan 25, 2019No Audible Alarm; Infusion or Flow Problem; No Audible Alarm; Infusion or Flow Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL IRRIGATION FAST FLOW FLUID WARMER LEVEL 1 DEVICE HAD NO FLOW, AND NO ALARM FAILURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8278526 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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