CADD 21-6500-51Recalls & 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 CADD infusion pump from ICU Medical is used to deliver fluids or medication over time. Reports mostly describe alarm problems, pumps failing to deliver or under-delivering, and air in the device. There are 8,203 reports, including 2 deaths and 15 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
- 8,231
- Deaths reported
- 2
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8,231 adverse event reports that list this exact device (DI 10610586019647), received between Dec 5, 2017 and Sep 30, 2026 — classified as 2 deaths, 15 injuries, 8,214 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (4,698 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
- Device Alarm System4,698
- Failure to Infuse679
- Insufficient Flow or Under Infusion621
- Audible Prompt/Feedback Problem469
- Air/Gas in Device437
- Device Sensing Problem321
- Excess Flow or Over-Infusion271
- Output Problem232
Patient problems
- No Clinical Signs, Symptoms or Conditions6,732
- Insufficient Information530
- No Patient Involvement432
- No Information388
- No Consequences Or Impact To Patient297
- No Known Impact Or Consequence To Patient210
- Nausea7
- Not Applicable7
Recent adverse event reports
The 25 most recent of 8,231 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950029 ↗MalfunctionSep 25, 2026Unexpected Shutdown
It was reported that the pump loses power during operation. There was no patient involvement or harm. However, if this unintended shutdown reoccurs during infusion, it will interrupt therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902931 ↗MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902879 ↗MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902789 ↗MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902723 ↗MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902280 ↗MalfunctionSep 25, 2026Pumping Problem
It was reported that the CADD-Legacy Plus pump experienced a "High Pressure" (HI-P) alarm during an infusion. Troubleshooting was attempted, but the alarm persisted. This high-priority alarm caused an interruption of therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900940 ↗MalfunctionSep 25, 2026Pumping Problem
It was reported that the CADD-Legacy Plus pump emitted a "Key Pressed or Stuck" alarm during an infusion. Troubleshooting was attempted, but the alarm returned after restarting the device. This high-priority alarm caused an interruption of therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900168 ↗MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899913 ↗MalfunctionSep 25, 2026Pumping Problem
It was reported that the CADD-Legacy Plus pump generated a "battery depleted" alarm during an infusion. The batteries were removed and replaced, but the alarm persisted. This high-priority alarm caused an interruption of therapy. There was patient involvement; however, no additional adverse consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897850 ↗MalfunctionSep 24, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890888 ↗MalfunctionSep 24, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889266 ↗MalfunctionSep 24, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888676 ↗MalfunctionSep 22, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860091 ↗MalfunctionSep 21, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846075 ↗MalfunctionSep 21, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845927 ↗MalfunctionSep 18, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830219 ↗MalfunctionSep 18, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828617 ↗MalfunctionSep 16, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794945 ↗MalfunctionSep 16, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793308 ↗MalfunctionSep 16, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792505 ↗MalfunctionSep 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779005 ↗MalfunctionSep 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777623 ↗MalfunctionSep 13, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747806 ↗MalfunctionSep 13, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747792 ↗
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6400-51Icu Medical, Inc. · Pump, infusion7 deaths7,543 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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