CADD 21-6500-13Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an ICU Medical CADD infusion pump, a portable pump used to deliver fluids and medicines, often at home. The 36 reports mostly describe alarm problems — the pump refusing to run, high-pressure alarms — plus failure to sense and unexpected shutdowns that stopped fluid from being delivered. No deaths or injuries were reported, and 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10610586022593), received between Nov 18, 2020 and Sep 8, 2022 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (24 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
- Device Alarm System24
- Output Problem15
- Failure to Sense6
- Unexpected Shutdown5
- Protective Measures Problem3
- Inaccurate Delivery2
- Loss of Power2
- Complete Loss of Power1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient3
- Dyspnea1
- Fatigue1
- Pain1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD A NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15379025 ↗MalfunctionSep 8, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD A NO DISPOSABLE ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15379019 ↗MalfunctionJul 19, 2022Protective Measures Problem
IT WAS REPORTED THAT THE A HIGH PRESSURE ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15051782 ↗MalfunctionJul 18, 2022Protective Measures Problem
IT WAS REPORTED THAT THE A HIGH PRESSURE ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15046330 ↗MalfunctionJul 18, 2022Protective Measures Problem
IT WAS REPORTED THAT THE A HIGH PRESSURE ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15046263 ↗MalfunctionJun 28, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT IN THE PATIENT'S HOME, A "NO DISPOSABLE, PUMP WON'T RUN" ALARM WENT OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14843748 ↗MalfunctionJun 20, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE "HIGH PRESSURE" ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14746791 ↗MalfunctionJun 20, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PUMP STOPPED AND MEDICAL FLUID WAS UNABLE TO BE INFUSED TO THE PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14746282 ↗MalfunctionJun 20, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE PUMP ALARM WENT OFF AND COULD NOT BE CLEARED. THE CASSETTE WAS CHANGED AND THE ALARM WAS SETTLED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14744918 ↗MalfunctionJun 13, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, A "NO DISPOSABLE, PUMP WON'T RUN" ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14682234 ↗MalfunctionJun 13, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, "NO DISPOSABLE, PUMP WON'T RUN" ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14682136 ↗MalfunctionJun 13, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING THE USE OF THE PUMP "NO MESSAGE" ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14682133 ↗MalfunctionJun 13, 2022Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PATIENT FELT THERE WAS AN ANOMALY IN THE INFUSION RATE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14681891 ↗MalfunctionJun 13, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT DURING THE USE OF THE PUMP "NO MESSAGE" ALARM WENT OFF. NO PATIENT INJURY WAS REPORTED..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14681823 ↗MalfunctionJun 13, 2022Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PATIENT FELT THERE WAS AN ANOMALY IN THE INFUSION RATE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14681780 ↗MalfunctionJun 8, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE PUMP ALARMED "NO DISPOSABLE, PUMP WON'T RUN". NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14632496 ↗MalfunctionDec 8, 2021Device Alarm System; Output Problem; Device Alarm System; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED "NO DISPOSABLE" ALARM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12961388 ↗MalfunctionDec 7, 2021Failure to Sense; Output Problem; Failure to Sense; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED "NO DISPOSABLE DETECTED" ALARM AFTER CONNECTING CASSETTE TO PUMP. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12957289 ↗MalfunctionDec 7, 2021Failure to Sense; Output Problem; Failure to Sense; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED "NO DISPOSABLE DETECTED" ALARM AFTER CONNECTING CASSETTE TO PUMP. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12957141 ↗MalfunctionDec 5, 2021Device Alarm System; Output Problem; Device Alarm System; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP EXHIBITED ALARM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12931342 ↗MalfunctionNov 26, 2021Device Alarm System; Output Problem; Device Alarm System; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED CONTINUOUS ALARM. IT WAS REPORTED THAT THE SUSPECTED ERROR CODE WAS #1600. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12879004 ↗MalfunctionNov 23, 2021Device Alarm System; Output Problem; Device Alarm System; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED "NO MESSAGE" ALARM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12865812 ↗MalfunctionNov 18, 2021Device Alarm System; Output Problem; Device Alarm System; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED "NO MESSAGE" ALARM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12841237 ↗MalfunctionNov 18, 2021Device Alarm System; Connection Problem; Output Problem; Device Alarm System; Connection Problem; Output Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED "NO DISPOSABLE, PUMP WON'T RUN" ALARM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12839918 ↗MalfunctionOct 28, 2021Device Alarm System; Failure to Sense; Device Alarm System; Failure to Sense
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED NO CASSETTE ALARM. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12711637 ↗
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 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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