CADD 21-7024-24Recalls & 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 10610586019852), received between Jan 6, 2020 and May 8, 2022 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (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 18, 2026.
Most reported problems
Device problems
- Device Alarm System4
- Fluid/Blood Leak2
- Insufficient Flow or Under Infusion2
- Mechanical Problem2
- Accessory Incompatible1
- Device Dislodged or Dislocated1
Patient problems
- No Information6
- No Clinical Signs, Symptoms or Conditions2
- 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.
MalfunctionMay 8, 2022Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT THERE WAS DIFFICULTY IN INSERTING CASSETTES ONTO PUMP TRIED SEVERAL PUMPS WITHOUT SUCCESS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14332536 ↗MalfunctionMay 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE CLAMP WAS MISSING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14313503 ↗MalfunctionDec 25, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE EDGE SEEN ON THE SET'S LOCKING MECHANISM ON A SMITHS MEDICAL DEVICE, WHICH RESULTED IN THE INABILITY TO DETACH IT FROM THE MACHINE.
Patient problems: Insufficient Information
MAUDE report 13085548 ↗MalfunctionFeb 3, 2021Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO INJURY OR CLINICAL CONSEQUENCE OBSERVED.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 11273924 ↗MalfunctionDec 30, 2020Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, TUBE LEAKING WAS OBSERVED DURING PURGING. SUBSEQUENTLY, THE TUBING WAS SWITCHED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 11096748 ↗MalfunctionDec 26, 2020Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PUMP DISPLAYED A "DISPOSABLE NOT PROPERLY ATTACHED, PLEASE RE-ATTACH" MESSAGE WHILE BEING USED WITH A CADD ADMINISTRATION SET, BUT THE ISSUE WOULD NOT DISAPPEAR. THERE WAS NO REPORTED ADVERSE EVENT.
Patient problems: No Information
MAUDE report 11073658 ↗MalfunctionFeb 19, 2020Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT AN ADMINISTRATION SET CONNECTED TO A SMITHS MEDICAL CADD INFUSION PUMP CAUSED AN UPSTREAM OCCLUSION ALARM. IT WAS NOTED THAT THE CARTRIDGE WAS DIFFICULT TO ATTACH TO THE PUMP. THE INFUSION WAS NOT LIFE SUSTAINING. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Information
MAUDE report 9728485 ↗MalfunctionJan 8, 2020Device Alarm System; Insufficient Flow or Under Infusion; Device Alarm System; Insufficient Flow or Under Infusion
INFORMATION WAS RECEIVED INDICATING THAT AN ADMINISTRATION SET CONNECTED TO A SMITHS MEDICAL CADD INFUSION PUMP WOULD NOT PRIME AND WOULD CAUSE THE PUMP TO GIVE AN ERROR MESSAGE ABOUT AN UPSTREAM OCCLUSION. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Information
MAUDE report 9564664 ↗MalfunctionJan 6, 2020Device Alarm System; Insufficient Flow or Under Infusion; Device Alarm System; Insufficient Flow or Under Infusion
INFORMATION WAS RECEIVED INDICATING THAT AN ADMINISTRATION SET CONNECTED TO A SMITHS MEDICAL CADD INFUSION PUMP WOULD NOT PRIME AND WOULD CAUSE THE PUMP TO GIVE AN ERROR MESSAGE ABOUT AN UPSTREAM OCCLUSION. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Information
MAUDE report 9555185 ↗
Other Set, administration, intravascular devices
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- 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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