CADD 21-7060-24Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586020438), received between Nov 27, 2019 and Sep 30, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (2 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 Flow2
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- No Audible Alarm1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2024No Audible Alarm; No Audible Alarm
IT WAS REPORTED THE BLOCKAGE ALARM DID NOT SOUND. EVEN IF THE OPERATOR CHANGED THE INSTRUMENT, IT DID NOT SOUND, AND IF THE OPERATOR REMOVED THE EXTENSION TUBE FROM THE CASSETTE, IT CAN PRIME, BUT THE PROBLEM WITH THE EXTENSION TUBE. THE EVENT OCCURRED AT THE PATIENT'S HOME. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334338 ↗MalfunctionSep 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKING OCCURRED DURING CLINICAL USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17674319 ↗MalfunctionJan 3, 2022Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD EXTENSION SET, AN OCCLUSION WAS NOTED, AND CUSTOMER COULD NOT FLOW FLUID IN IT. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13142484 ↗MalfunctionNov 27, 2019Obstruction of Flow; Obstruction of Flow
INFORMATION RECEIVED A SMITHS MEDIAL CADD EXTENSION SETS CUSTOMER NOTICED OCCLUSION, EVEN WHEN PRESSING ON PLUNGER FOR THIS WAS CHECKED DURING PRECHECK AND WOULD NOT GO FORWARD. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9386681 ↗
Other Set, administration, intravascular devices
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- 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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