CADD 21-7040-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10610586020223), received between Jun 30, 2020 and Oct 29, 2022 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (5 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 18, 2026.
Most reported problems
Device problems
- Device Alarm System5
- Air/Gas in Device1
- Failure to Deliver1
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2022Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash
IT WAS REPORTED THAT THE DEVICE WAS LEAKING AND ALSO SHOWING DOWNSTREAM OCCLUSION ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695009 ↗MalfunctionSep 1, 2022Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE MEDICAL DEVICE FAILED AND MEDICATION DID NOT COME OUT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337359 ↗MalfunctionJan 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE WITH THE EXTENSION SET WHEN STARTING NEW DRUG LOAD. THE LEAKAGE APPEARED WHEN THE SET WAS REMOVED FROM THE ORIGINAL PACKAGING AND IT WAS CONNECTED TO THE CASSETTE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13341820 ↗MalfunctionJan 25, 2022Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THE DEVICE DISPLAYED ALARM -AIR IN LINE-. WHILE PRIMING MEDICINE, IT DOES NOT MAKE IT THROUGH THE EXTENSION SET AND GENERATES HIGH PRESSURE ALARM. EXTENSION SET WAS CHANGED AND INFUSION STARTED CORRECTLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13341653 ↗MalfunctionNov 8, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT DURING PRE-TEST OF A SMITHS MEDICAL CADD EXTENSION SET, AN AUDIBLE ALARM WAS NOTED, AND INFUSION STOPPED. SUBSEQUENTLY, THE CASSETTE WAS CHANGED. NO PATIENT WAS INVOLVED IN THIS EVENT. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12770995 ↗MalfunctionNov 8, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD EXTENSION SET, AN AUDIBLE ALARM WAS NOTED, AND INFUSION STOPPED. SUBSEQUENTLY, THE CASSETTE WAS CHANGED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12770791 ↗MalfunctionNov 8, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD EXTENSION SET, AN AUDIBLE ALARM WAS NOTED, AND INFUSION STOPPED. SUBSEQUENTLY, THE CASSETTE WAS CHANGED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12770778 ↗MalfunctionNov 7, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT A HIGH-PRESSURE ALARM WAS NOTED WITH A SMITHS MEDICAL CADD EXTENSION SET, AND THREE VIALS OF MEDICATION WAS LOST . NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12758925 ↗MalfunctionJun 30, 2020Infusion or Flow Problem; Infusion or Flow Problem
INFORMATION WAS RECEIVED THAT DURING PRE-TESTING OF THIS SMITHS MEDICAL CADD EXTENSION SETS, THE SET DID NOT ALLOWED MEDICATION OUT. NO REPORTED ADVERSE EFFECTS OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10211939 ↗
Other Set, administration, intravascular devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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