CADD 21-7023-24Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586019821), received between Mar 9, 2018 and Mar 20, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
1 other recall cover devices cleared under the same FDA submission (K933390); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Alarm System1
- Occlusion Within Device1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2018Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT AN UNKNOWN ALARM OCCURRED TO A SMITHS MEDICAL CADD® AMBULATORY INFUSION PUMP. THE CASSETTE WAS CHANGED OUT WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7355579 ↗MalfunctionMar 9, 2018Occlusion Within Device; Occlusion Within Device
IT WAS REPORTED THAT A CADD® ADMINISTRATION SET CAUSED THE PUMP TO ALARM "UPSTREAM OCCLUSION". THIS OCCURRED DURING USE AFTER THE SET-UP OF THE CASSETTE AND THE INFUSION TUBE, WHICH WAS NOTED AS BEING "VERY DIFFICULT". THE ALARM WAS CLEARED AFTER REPLACING THE INFUSION TUBE. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7328509 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K933390. One submission often covers many models, so check the product and lot details in each record.
- Z-2759-2017 · Dec 9, 2016 · TerminatedSmiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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