CADD 21-7365-24Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517191707), received between Mar 24, 2022 and Feb 16, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K031361); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device1
- Device Alarm System1
- Fluid/Blood Leak1
- Insufficient Flow or Under Infusion1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE, THE DEVICE EXHIBITED A LEAK AT THE CONNECTION POINT WHERE THE CLEAR TUBING CONNECTS TO THE WHITE PLASTIC SPIKE. PER THE REPORTER, THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18726454 ↗MalfunctionDec 15, 2023Obstruction of Flow; Air/Gas in Device; Obstruction of Flow; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE TUBING DEVELOPED AN AIRLOCK AND MEDICATION COULD NOT BE RUN THROUGH THE TUBING. IT WAS STATED THAT USING A PUMP DID NOT HELP AS IT STILL WOULD NOT RUN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18339524 ↗MalfunctionMar 24, 2022Device Alarm System; Insufficient Flow or Under Infusion; Device Alarm System; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE DEVICE WAS ALARMING WITH DOWNSTREAM OCCLUSION ALARM AND UNDERDELIVERED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13895128 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.
- Z-0962-2023 · Dec 9, 2022 · Open, ClassifiedCADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
- Z-0148-2022 · Jul 14, 2020 · TerminatedCADD Administration Sets, Model #21-7346-24
- Z-2589-2017 · May 15, 2017 · TerminatedCADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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