Cleo 21-7220-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Cleo (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical CADD Cleo infusion set is tubing used to deliver medicine into the body. Its 2,021 adverse event reports mostly describe fluid or blood leaks, blocked flow, and bent tubing, and some mention high blood sugar. The reports include no deaths and 199 injuries. Reports in the last 12 months number 1,494, up from 59 in the previous 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,083
- Deaths reported
- 0
- Injuries reported
- 205
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,083 adverse event reports that list this exact device (DI 30610586028339), received between Sep 17, 2016 and Sep 30, 2026 — classified as 205 injuries, 1,876 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (508 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
- Obstruction of Flow508
- Fluid/Blood Leak439
- Material Twisted/Bent300
- Detachment of Device or Device Component240
- Complete Blockage165
- Patient Device Interaction Problem126
- Break43
- Leak/Splash42
Patient problems
- No Clinical Signs, Symptoms or Conditions1,624
- Hyperglycemia207
- Erythema49
- Elevated Ketones/ Diabetic Ketoacidosis28
- Skin Inflammation/ Irritation28
- Swelling/ Edema26
- No Consequences Or Impact To Patient24
- Vomiting18
Recent adverse event reports
The 25 most recent of 2,083 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953920 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50953688 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953663 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953625 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953583 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953544 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953522 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953497 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953467 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953048 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952859 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952848 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952838 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952836 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952598 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952452 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952366 ↗MalfunctionSep 30, 2026Obstruction of Flow; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50952040 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951922 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951912 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951762 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951726 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951509 ↗MalfunctionSep 30, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951402 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported that the patient experienced ¿Line Blocked¿ alarms due to bent cannulas in the Cleo 90 infusion set. The issue was resolved by replacing the infusion set and changing the infusion site. There was patient involvement, but no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951359 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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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