CADD 21-7105-24Recalls & 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
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10610586022715), received between Oct 31, 2019 and Feb 18, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow5
- Infusion or Flow Problem4
- Complete Blockage2
- Blocked Connection1
- Device Alarm System1
- Inaccurate Delivery1
- Pressure Problem1
- Volume Accuracy Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient3
- Insufficient Information2
- No Patient Involvement1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Complete Blockage
IT WAS REPORTED THAT THE EPIDURAL PUMP EXHIBITED AN OCCLUSION ON PATIENT-SIDE AND WAS UNABLE TO DELIVER THE MEDICATION. THE PUMP, EPIDURAL CARTRIDGE, AND EPIDURAL TUBING WERE ALL REPLACED. THEY WERE FINALLY ABLE TO GET MEDICATION RAN WITH THE THIRD TUBING. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381780 ↗MalfunctionOct 27, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THERE WAS AN OCCLUSION DURING PURGING AND WHEN IGNITING THE PUMP ONCE TURNED OFF TO RE-PURGE. PATIENT WAS NOT RELIEVED IMMEDIATELY BECAUSE CADD PUMP WAS SET WITH A FEW MINUTES DELAY DUE TO OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23398340 ↗MalfunctionFeb 20, 2025Blocked Connection; Blocked Connection
IT WAS REPORTED THAT THE EXTENSION SET EXHIBITED A DOWNSTREAM OCCLUSION. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426395 ↗MalfunctionJul 24, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE PUMP HAS BEEN EXPERIENCING OCCLUSIONS ALARMS AND IT WAS NOT BELIEVED TO BE ASSOCIATED WITH THE PUMP OR THE CASSETTE AS THE ISSUE WAS RESOLVED WHEN THE EXTENSION TUBING WAS REPLACED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817837 ↗MalfunctionJun 26, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE CATHETER WAS NOT FLUSHING PROPERLY AND LOOKED TO POSSIBLY BE OCCLUDED ON ONE SIDE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19619201 ↗MalfunctionMay 26, 2023Volume Accuracy Problem; Inaccurate Delivery; Volume Accuracy Problem; Inaccurate Delivery
IT WAS REPORTED THE DISPOSABLE CAUSED DOSING ISSUE OR DIVERSION ISSUES WITH CADD PUMPS. THE EVENT AFFECTED PATIENT CARE.
Patient problems: Insufficient Information
MAUDE report 17011141 ↗MalfunctionJul 7, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE DEVICE CAUSED THE PUMP TO EXHIBIT OCCLUSION ERROR ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14945092 ↗MalfunctionJul 7, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE DEVICE CAUSED THE PUMP TO EXHIBIT OCCLUSION ERROR ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14945068 ↗MalfunctionNov 4, 2020Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THE DEVICE WAS BEING PREPARED AND FILLED WITH DRUG. THE REPORTER STATED THE DRUG "COULD NOT BE RELEASED" FROM THE CASSETTE INTO THE TUBING. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10788651 ↗MalfunctionJul 24, 2020Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
INFORMATION WAS RECEIVED INDICATING THAT HIGH PRESSURE ALARM WAS NOTED WITH THE USE OF A SMITHS MEDICAL CADD EXTENSION SET THAT LED TO DELAY OF MEDICATION. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10320406 ↗MalfunctionOct 31, 2019Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A DELIVERY ISSUE THAT OCCURRED THREE TIMES WITH A FENTANYL INFUSION. THE ALLEGATION OF MALFUNCTION IS ON THE CADD CASSETTE RESERVOIR. THE PATIENT REPORTED THAT TWO UNITS HAVE A "FAULTY MINUTE AV BUBBLES" IN THE LINE DESPITE FLUSHING. THE ISSUES REPORTED WERE AIR BUBBLES AND DOWNSTREAM OCCLUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9263229 ↗MalfunctionOct 31, 2019Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A DELIVERY ISSUE THAT OCCURRED THREE TIMES WITH A FENTANYL INFUSION. THE ALLEGATION OF MALFUNCTION IS ON THE CADD CASSETTE RESERVOIR. THE PATIENT REPORTED THAT TWO UNITS HAVE A "FAULTY MINUTE AV BUBBLES" IN THE LINE DESPITE FLUSHING. THE ISSUES REPORTED WERE AIR BUBBLES AND DOWNSTREAM OCCLUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9263177 ↗
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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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