CADD 21-7034-24Recalls & 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
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10610586020162), received between Aug 4, 2017 and May 7, 2022 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash5
- Fluid/Blood Leak3
- Fitting Problem2
- Mechanical Problem2
- Defective Device1
- Detachment of Device or Device Component1
- Infusion or Flow Problem1
- Insufficient Flow or Under Infusion1
Patient problems
- No Consequences Or Impact To Patient4
- Inadequate Pain Relief2
- Missed Dose2
- No Clinical Signs, Symptoms or Conditions2
- No Information2
- No Patient Involvement1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PURGE, THE TUBING WAS SEVERED NEAR THE IMMUNOTHERAPY'S CONNECTOR BAG. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14313505 ↗MalfunctionMay 6, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THERE WAS A DEFECT IN THE ADMINISTRATION SET. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14311833 ↗MalfunctionFeb 19, 2021Mechanical Problem; Fitting Problem; Mechanical Problem; Fitting Problem
INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE, A SMITHS MEDICAL CADD ADMINISTRATION SET WAS DIFFICULT TO FIT ON THE PUMP, SO AN OCCLUSION WAS IDENTIFIED. IT WAS ALSO REPORTED THAT THE SET WAS IMPOSSIBLE TO UNCLIP FROM THE PUMP. THE REPORTER ALSO INDICATED THAT PATIENT WAS INSUFFICIENTLY RELIEVED IN TERMS OF PAIN BECAUSE THE PUMP WENT INTO OCCLUSION IN THE MIDDLE OF THE NIGHT AND DID NOT NOTIFY THE HOME HEALTH AGENCY UNTIL 6AM. SUBSEQUENTLY, A CHANGE OF PUMP AND SET WAS PERFORMED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 11349846 ↗MalfunctionFeb 19, 2021Mechanical Problem; Fitting Problem; Mechanical Problem; Fitting Problem
INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE, A SMITHS MEDICAL CADD ADMINISTRATION SET WAS DIFFICULT TO FIT ON THE PUMP, SO AN OCCLUSION WAS IDENTIFIED. IT WAS ALSO REPORTED THAT THE SET WAS IMPOSSIBLE TO UNCLIP FROM THE PUMP. THE REPORTER ALSO INDICATED THAT PATIENT WAS INSUFFICIENTLY RELIEVED IN TERMS OF PAIN BECAUSE THE PUMP WENT INTO OCCLUSION IN THE MIDDLE OF THE NIGHT AND DID NOT NOTIFY THE HOME HEALTH AGENCY UNTIL 6AM. SUBSEQUENTLY, A CHANGE OF PUMP AND SET WAS PERFORMED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 11349666 ↗MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THERE WAS LEAKAGE FROM THE TUBING OF A SMITHS MEDICAL CADD ADMINISTRATION SET. THERE WAS NO CLINICAL OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11195686 ↗MalfunctionJul 2, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING A PRE-TEST, A SMITHS MEDICAL CADD ADMINISTRATION SET HAD LOWER FLOW THAN 6%. NO PATIENT WAS INVOLVED IN THIS EVENT. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10224007 ↗MalfunctionMar 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, THE CADD SETS HAD "HOLES" AND MEDICATION COULD NOT BE ADMINISTRATED TO THE PATIENTS BECAUSE THERE WAS A RUPTURE OF THE TREATMENT. IT WAS REPORTED THAT THE CADD SET WAS CHANGED AND PORT CATH WAS CLOGGED, AND THE PATIENT WAS TRANSFERRED TO EMERGENCY. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 9777187 ↗MalfunctionMar 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, THE CADD SETS HAD "HOLES" AND MEDICATION COULD NOT BE ADMINISTRATED TO THE PATIENTS BECAUSE THERE WAS A RUPTURE OF THE TREATMENT. IT WAS REPORTED THAT THE CADD SET WAS CHANGED AND PORT CATH WAS CLOGGED, AND THE PATIENT WAS TRANSFERRED TO EMERGENCY. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 9777174 ↗MalfunctionAug 8, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF A CADD® ADMINISTRATION SET LEAKED DURING THE PATIENT'S TREATMENT. THE PATIENT WENT TO THE EMERGENCY ROOM "FOR DISCONNECT" AND DID NOT RECEIVE THE DRUG. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Missed Dose
MAUDE report 6773812 ↗MalfunctionAug 8, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF A CADD® ADMINISTRATION SET LEAKED DURING THE PATIENT'S TREATMENT. THE PATIENT WENT TO THE EMERGENCY ROOM "FOR DISCONNECT" AND DID NOT RECEIVE THE DRUG. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Missed Dose
MAUDE report 6773799 ↗MalfunctionAug 4, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF A CADD® ADMINISTRATION SET LEAKED SPONTANEOUSLY FROM A MANUFACTURED SEALED JOINT, IMMEDIATELY DISTAL TO THE CASSETTE. THE DEVICE WAS BEING USED IN A MEDICAL DAYCARE. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6768368 ↗MalfunctionAug 4, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF A CADD® ADMINISTRATION SET LEAKED SPONTANEOUSLY FROM A MANUFACTURED SEALED JOINT, IMMEDIATELY DISTAL TO THE CASSETTE. THE DEVICE WAS BEING USED IN A MEDICAL DAYCARE. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6768115 ↗MalfunctionAug 4, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE TUBING OF A CADD® ADMINISTRATION SET LEAKED SPONTANEOUSLY FROM A MANUFACTURED SEALED JOINT, IMMEDIATELY DISTAL TO THE CASSETTE. THE DEVICE WAS BEING USED IN A MEDICAL DAYCARE. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6768112 ↗
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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