Cleo 21-7231-24Recalls & 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 Cleo infusion set is a tube set that delivers medicine, such as insulin, from a pump into the body. Many of the 114 reports describe parts detaching, the tubing blocking or leaking, and the adhesive not staying on the skin. The reports include 49 injuries and no deaths, and 41 list high blood sugar. 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
- 114
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 30610586028407), received between Feb 10, 2017 and Jan 29, 2025 — classified as 49 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (20 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
- Detachment Of Device Component20
- Detachment of Device or Device Component14
- Material Fragmentation14
- Partial Blockage14
- Failure To Adhere Or Bond13
- Break11
- Device Alarm System8
- Leak/Splash7
Patient problems
- Hyperglycemia41
- No Clinical Signs, Symptoms or Conditions32
- Device Embedded In Tissue or Plaque31
- Inflammation14
- Hemorrhage/Blood Loss/Bleeding6
- No Consequences Or Impact To Patient4
- Chemical Exposure3
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking
IT WAS REPORTED THAT THE INSERTION AID COULD ONLY BE REMOVED WITH THE HELP OF ANOTHER PERSON AND THIS OCCASIONALLY BENT THE TUBE AND LED TO THE ERROR MESSAGES DURING INSULIN RELEASE. THE MESSAGE ¿TUBE BLOCKED¿ APPEARED ALTHOUGH 20 UNITS WERE STILL INCLUDED. THE ISSUE OCCURRED IMMEDIATELY UPON USE. THERE WAS NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21269882 ↗MalfunctionApr 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE TUBING LEAKED BETWEEN THE RESERVOIR AND THE TUBING DURING INFUSION. THERAPEUTIC APOMORPHINE DILUTION 50 PERCENT. THERE WAS PATIENT INVOLVEMENT BUT UNKNOWN PATIENT HARM/ADVERSE EVENT.
Patient problems: Insufficient Information
MAUDE report 19166509 ↗MalfunctionMar 8, 2024Connection Problem; Connection Problem
IT WAS REPORTED THE DISPOSABLE EXHIBITED A "LUER LOCK CONNECTOR FAULT". UNKNOWN IF THERE WAS AN ADVERSE PATIENT HARM/ADVERSE EVENT. FOUR DISPOSABLES WERE AFFECTED.
Patient problems: Insufficient Information
MAUDE report 18869352 ↗MalfunctionJan 5, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE DEVICE EXHIBITED A LEAK BETWEEN THE TUBING AND LUER LOCK CONNECTION. PERFUSION WAS BEING USED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449702 ↗MalfunctionMay 10, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED, THAT THE DEVICE HAD A LEAKAGE. AND THE PATIENT DID NOT RECEIVE HIS DAILY DOSE OF TREATMENT, AND THIS LED TO BLOCKAGES. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16902788 ↗MalfunctionMay 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED ADHESIVE WOULD NOT STAY ON PATIENT'S SKIN WHILE IN USE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16891940 ↗MalfunctionMay 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED ADHESIVE WOULD NOT STAY ON PATIENT'S SKIN WHILE IN USE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16891898 ↗MalfunctionMay 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED ADHESIVE WOULD NOT STAY ON PATIENT'S SKIN WHILE IN USE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16891189 ↗MalfunctionMay 5, 2023Mechanical Problem; Deformation Due to Compressive Stress; Mechanical Problem; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE NEEDLE COULD NOT BE SET PROPERLY BECAUSE THE ADHESIVE DOESN'T HOLD TIGHT ENOUGH. THUS, THE NEEDLE SLIPS OUT OR KINKS. CUSTOMER RECALLED THE REPORTED INCIDENT APPLICATION ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16881889 ↗MalfunctionMay 5, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER WAS BENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 24-JUN-2021: INCIDENT OCCURRED BEFORE USE. NO CLINICAL CONSEQUENCE OR INJURY FOR PATIENT. NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874067 ↗MalfunctionJan 11, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE CATHETER IS LEAKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16140281 ↗MalfunctionDec 2, 2022Failure to Advance; Failure to Advance
IT WAS REPORTED THAT AT THE MOMENT OF THE APPLICATION, NEEDLE PRICKED IN THE CAP. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15908535 ↗MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PRODUCT IS LEAKING AT THE LUERLOCK. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15680770 ↗MalfunctionOct 12, 2022Break; Break
IT WAS REPORTED THAT THE CANNULA WAS BROKEN DURING REMOVAL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591699 ↗MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PART OF THE CANNULA REMAINED STUCK IN THE SKIN OF THE PATIENT DURING THE REMOVAL OF THE SET. THE SET WAS INSTALLED FOR LESS THAN 24 HOURS. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591694 ↗MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SETT UP OF THE CATHETER, THE ADHESIVE DIAPHRAGMS REMAINED STUCK TO THE PATIENT'S BELLY. THE NEEDLE REMAINED IN THE PATIENT'S SKIN. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591688 ↗MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BROKEN CANNULA WAS LEFT EMBEDDED IN PATIENT'S SKIN. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591660 ↗MalfunctionOct 12, 2022Break; Break
IT WAS REPORTED THAT THE CANNULA WAS BROKEN DURING REMOVAL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591607 ↗MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CATHETER TOP BROKE OFF AND REMAINED IN THE SKIN AND ENCAPSULATED. AN CHERRY-GREEN, BLUISH-RED DISCOLORATION / INFLAMMATION AROUND A BROKEN TEFLON SHEATH (FLEXIBLE NEEDLE) OF CATHETER. WHEN ATTEMPTING TO REMOVE THE CATHETER AS USUAL AFTER SUSPENDING THE INFUSION PUMP, IT BROKE OFF AND HAS SINCE BEEN LEFT IN THE SUBCUTIS IN THE AREA OF THE RIGHT SHOULDER. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: Skin Discoloration; Skin Inflammation/ Irritation
MAUDE report 15591540 ↗MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CANNULA DISCONNECTED FROM THE ADHESIVE DISC UPON REMOVAL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15591489 ↗MalfunctionSep 29, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE DEVICE HAD BLOOD IN THE TUBING. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 15502890 ↗MalfunctionSep 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN ANOMALY WAS OBSERVED IN THE NEEDLE DURING THE INSERTION THAT REQUIRED A CATHETER CHANGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15492327 ↗MalfunctionSep 10, 2022Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE DEVICE NEEDLE DID NOT RETRACT AFTER THE SET'S APPLICATION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397768 ↗MalfunctionSep 9, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE PUMP WAS RUNNING BUT NOTHING WAS FLOWING OUT OF THE TUBING. THE PATIENT CHANGED OUT THE TUBING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392621 ↗MalfunctionSep 6, 2022Break; Break
IT WAS REPORTED FROM THE IRISH MARKETPLACE THAT A CUSTOMER RETURNED A SAFETY INFUSION SET BECAUSE THE NEEDLE IS FAULTY. THE REQUESTED INFORMATION IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15361943 ↗
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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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