CADD 80-01-040Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50695085804008), received between Dec 5, 2020 and Apr 26, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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 16, 2026.
Most reported problems
Device problems
- Failure to Deliver2
- Failure to Calibrate1
Patient problems
- Insufficient Information2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE UNIT WAS NOT FUNCTIONING PROPERLY. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 16820188 ↗MalfunctionApr 26, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE UNIT WAS NOT FUNCTIONING PROPERLY. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 16816451 ↗MalfunctionDec 5, 2020Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED THE DEVICE "NEEDED CALIBRATION AND REPAIR". NO FURTHER INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 10953392 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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