CleoRecalls & reported problems across all models
Icu Medical, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,782
- Deaths reported
- 1
- Injuries reported
- 400
- Recalls
- 0
We found 6 models of Cleo by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,782 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2016 and Sep 30, 2026 — classified as 1 death, 400 injuries, 2,379 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (532 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cleo problems
Device problems
- Obstruction of Flow532
- Fluid/Blood Leak496
- Material Twisted/Bent312
- Detachment of Device or Device Component287
- Patient Device Interaction Problem244
- Complete Blockage172
- Leak/Splash101
- Device Alarm System73
Patient problems
- No Clinical Signs, Symptoms or Conditions1,882
- Hyperglycemia405
- Erythema93
- Device Embedded In Tissue or Plaque69
- No Consequences Or Impact To Patient44
- Skin Inflammation/ Irritation44
- Swelling/ Edema43
- Cellulitis29
Cleo models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cleo 21-7220-24Set, administration, intravascular2,083 reports
- Cleo 21-7230-24Set, administration, intravascular383 reports
- Cleo 21-7221-24Set, administration, intravascular1 death127 reports
- Cleo 21-7231-24Set, administration, intravascular114 reports
- Cleo 21-7232-24Set, administration, intravascular49 reports
- Cleo 21-7222-24Set, administration, intravascular26 reports
Recent Cleo adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Icu Medical, Inc. products
- CADD123 models · 53,012 reports · 21 recalls
- Medfusion16 models · 13,114 reports · 5 recalls
- Bivona469 models · 2,811 reports · 29 recalls
- Level 152 models · 3,733 reports · 1 recall
- Portex409 models · 3,479 reports · 5 recalls
- Pneupac23 models · 1,972 reports
- Medex98 models · 774 reports · 23 recalls
- Plum26 models · 1,358 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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