CADD 21-7108-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586034480), received between May 6, 2022 and May 5, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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
- Fluid/Blood Leak4
- Defective Component1
- Increase in Pressure1
- Leak/Splash1
- Obstruction of Flow1
- Partial Blockage1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Partial Blockage; Increase in Pressure; Defective Component; Partial Blockage; Increase in Pressure; Defective Component
IT WAS REPORTED THAT THE PRODUCT WAS DEFECTIVE, IT INDICATED HIGH PRESSURE IN THE PCA PUMP, EVEN AFTER CHANGING THE DEVICE, ALTHOUGH AFTER CHANGING THE DISPOSABLE, THE PUMP WORKED NORMALLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960697 ↗MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE EPIDURAL INFUSION TUBING HAD SEVERAL LEAKS AT THE IN-LINE FILTER SITE. THE EVENT OCCURRED MULTIPLE TIMES WITH THE ITEM. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20004748 ↗MalfunctionApr 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DISPOSABLE EXHIBITED LEAKAGE OUT OF THE WHITE CIRCLE PIECES. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19055930 ↗MalfunctionJan 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE, THE EXTENSION SET EXHIBITED SEVERAL LEAKAGES AROUND THE IN-LINE FILTER AREA IN THE LABOR AND DELIVERY UNIT. IT WAS NOTED THAT SOME LABOR PATIENTS REQUIRED ADDITIONAL MEDICATIONS TO HELP WITH THEIR LABOR PAIN MORE THAN USUAL. IT IS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT EFFECTS.
Patient problems: Insufficient Information
MAUDE report 18449554 ↗MalfunctionJan 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE EPIDURAL INFUSION TUBING HAD SEVERAL LEAKS AT THE IN-LINE FILTER SITE. THE EVENT OCCURRED MULTIPLE TIMES WITH THE ITEM. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18449503 ↗MalfunctionNov 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT EXTENSION SET EXHIBITED MULTIPLE MEDICATION LEAKAGE FROM THE AIR BUBBLE/AIR FILTER. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18212560 ↗MalfunctionNov 8, 2023
EPIDURAL INFUSION TUBING WAS LEAKING AT THE FILTER SITE OF THE EPIDURAL TUBING, THIS WAS DISCOVERED. THIS HAS HAPPENED MULTIPLE TIMES WITH THIS & PRODUCT/LOT #.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18102967 ↗MalfunctionMay 6, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE LINE WAS CLOGGED AND WAS NOT WORKING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14307131 ↗
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- 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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