CADD 21-7046-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical administration set is used to deliver fluids and chemotherapy intravenously. The reports mostly describe tubing that will not flow because the line is blocked or the pump shows an obstruction or air-in-line alarm, plus leaks at the connection and pieces breaking off. There are 45 reports, all describing malfunctions, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10610586020308), received between Apr 17, 2019 and Oct 29, 2025 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (18 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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device18
- Fluid/Blood Leak10
- Material Fragmentation8
- Obstruction of Flow6
- Complete Blockage5
- Device Alarm System4
- Failure to Infuse4
- Excess Flow or Over-Infusion2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient12
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE TUBING FAILED. AN OCCLUSION ALERT OCCURRED. ANOTHER TUBING WAS USED AND THE DEVICE WORKED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415679 ↗MalfunctionJul 21, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow
IT WAS REPORTED THAT, ONCE AGAIN THERE ARE OCCLUSION ISSUES, DESPITE THE EQUIPMENT BEING INTACT, AND AFTER PERFORMING MANUAL PURGING AND REPLACING THE PUMP, AMONG OTHER STEPS. THE ISSUE WAS RESOLVED BY SWITCHING TO A DIFFERENT BATCH (CASSETTES AND TUBING). THE REPORTED ISSUE WAS DESCRIBED AS "PURGE IMPOSSIBLE/OCCLUSION", WHICH OCCURRED BEFORE USE ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22556604 ↗MalfunctionJun 19, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow
IT WAS REPORTED THAT WHEN THE EXTENSION SETS WERE CONNECTED TO THE PUMP, IT DISPLAYED "OBSTRUCTION" NOT ALLOWING TO START THE PUMP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292515 ↗MalfunctionJun 19, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow
IT WAS REPORTED THAT WHEN THE EXTENSION SETS WERE CONNECTED TO THE PUMP, IT DISPLAYED "OBSTRUCTION" NOT ALLOWING TO START THE PUMP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292487 ↗MalfunctionJun 19, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow
IT WAS REPORTED THAT WHEN THE EXTENSION SETS WERE CONNECTED TO THE PUMP, IT DISPLAYED "OBSTRUCTION" NOT ALLOWING TO START THE PUMP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292376 ↗MalfunctionJan 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THEY NOTICED A DRIED WHITE RESIDUE ON PATIENT'S SHOULDER AND SUSPECTED THE CHEMO WAS LEAKING. THEY SAW A LEAK BETWEEN TUBING AND LEUR LOCK CLOSEST TO PATIENT'S PORT. TUBING WAS NEVER COMPLETELY DISCONNECTED. RESERVOIR VOLUME DECREASED TO 99.3 WITHOUT ANY LEAKS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21256634 ↗MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20326781 ↗MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT TWO PUMPS WERE TRIED WITH THIS TUBING, AND BOTH HAD AN AIR IN LINE ALARM. THE CASSETTES AND TUBING CONTAINED CHEMOTHERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20326067 ↗MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321875 ↗MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321793 ↗MalfunctionSep 27, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20317963 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20316521 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20315842 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314798 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314737 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314228 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314014 ↗MalfunctionSep 26, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20312999 ↗MalfunctionSep 20, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20267961 ↗MalfunctionSep 20, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20267798 ↗MalfunctionSep 20, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE CASSETTE WAS USED FOR CHEMOTHERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266664 ↗MalfunctionSep 20, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266621 ↗MalfunctionSep 20, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266594 ↗MalfunctionSep 18, 2024Excess Flow or Over-Infusion; Air/Gas in Device; Excess Flow or Over-Infusion; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN INTERNAL QUALITY ASSURANCE ON THEIR INFUSIONS AND NOTICED AN INCREASED TREND OF AIR IN LINE ALARMS ALONG WITH INFUSION ENDING 2.5 HOURS EARLY. PER REPORTER, IT HAD AN AIR IN LINE THAT WAS FIRING. THE CUSTOMER CALCULATED DELIVERY ACCURACY AND SOME CASES THE INFUSION WAS IN THE SPEC, BUT IN OTHERS THE ACCURACY RANGES FROM 11.5% UP TO 21%. THE PRODUCT FAULT OCCURRED WHILE IN USE WITH A PATIENT. NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246610 ↗MalfunctionSep 16, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE DEVICE SHOWED THAT THERE SHOULD BE FLUID LEFT IN THE CASSETTE, BUT THE CASSETTE WAS DONE DRY. PER REPORTER, THE TOTAL CASSETTE VOLUME WAS 55.2ML, RESERVOIR VOLUME: 5.2ML AND GIVEN: 55.2ML (CASSETTE WAS DRY). THE EVENT OCCURRED IN THE PATIENT¿S HOME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20228845 ↗
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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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