CADD 21-6300-51Recalls & 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 ICU Medical CADD infusion pump delivers medicine through an IV line. Its 409 adverse event reports often describe alarms, medicine that fails to infuse, and flow that is too fast, too slow or blocked, with some describing error codes during setup. The reports include no deaths and no 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
- 414
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 414 adverse event reports that list this exact device (DI 10610586019449), received between Mar 9, 2018 and Sep 23, 2026 — classified as 414 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (148 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 System148
- Failure to Infuse81
- Excess Flow or Over-Infusion39
- Insufficient Flow or Under Infusion25
- Device Sensing Problem18
- Obstruction of Flow17
- Infusion or Flow Problem15
- Inaccurate Delivery14
Patient problems
- No Clinical Signs, Symptoms or Conditions302
- Insufficient Information56
- No Information23
- No Consequences Or Impact To Patient18
- No Patient Involvement14
- No Known Impact Or Consequence To Patient7
- Pain4
- Numbness3
Recent adverse event reports
The 25 most recent of 414 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Pumping Problem
It was reported that the pump generated a "High Pressure (Hi-P)" alarm. The issue could not be resolved, and the pump was not running at the conclusion of the call. The medication being infused was Ropivacaine; however, the programmed infusion rate, remaining volume, and volume infused could not be obtained. The event occurred during infusion. There was patient involvement; however, no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869652 ↗MalfunctionSep 16, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793328 ↗MalfunctionSep 16, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793302 ↗MalfunctionSep 7, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658558 ↗MalfunctionSep 2, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564799 ↗MalfunctionAug 28, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506513 ↗MalfunctionAug 28, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504418 ↗MalfunctionJul 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25833528 ↗MalfunctionJul 14, 2026Thermal Decomposition of Device
IT WAS REPORTED INITIALLY BY THE CUSTOMER THAT THE BOLUS DOSE CANNOT BE GIVEN BY THE INFUSION PUMP, AND THIS OCCURRED DURING STARTUP. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814905 ↗MalfunctionJun 15, 2026Device Sensing Problem
IT WAS REPORTED THAT THE PUMP HAD A HIGH-PRESSURE ALARM DURING TESTING AND WAS DUE TO A DAMAGED DOWNSTREAM OCCLUSION (DSO) SENSOR. THERE WAS NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512226 ↗MalfunctionJun 5, 2026No Flow
IT WAS REPORTED THAT THE MEDICINE WAS NOT RUN IN THE PUMP OCCURRED AT HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414766 ↗MalfunctionMay 27, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE DISPLAYED ERROR CODE LEC1280. THE EVENT OCCURRED DURING SETUP AND THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301891 ↗MalfunctionMay 26, 2026Failure to Sense
IT WAS REPORTED THAT THE DEVICE HAS AN ERROR CODE LEC1535. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED. THE EVENT OCCURRED DURING SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279041 ↗MalfunctionMay 26, 2026Failure to Sense
IT WAS REPORTED THAT THE DEVICE HAS AN ERROR CODE LEC1535. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED. THE EVENT OCCURRED DURING SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279039 ↗MalfunctionMay 20, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE HAS AN ERROR CODE LEC1720. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED. THE EVENT OCCURRED DURING SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230204 ↗MalfunctionMay 20, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE HAS AN ERROR CODE LEC1535. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED. THE EVENT OCCURRED DURING SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230196 ↗MalfunctionMay 15, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP ALARMED FOR UPSTREAM OCCLUSION, AND IT COULD NOT BE RESOLVED. THE EVENT OCCURRED DURING INFUSION, WITH PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183032 ↗MalfunctionMay 5, 2026Failure to Infuse; Device Sensing Problem
IT WAS REPORTED THAT THE UNIT WAS CONTINUOUSLY BEEPING WITH OR WITHOUT A SET ATTACHED AND DID NOT GENERATE A LAST ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS DISCOVERED DURING TESTING. EVALUATION OF THE RETURNED DEVICE IDENTIFIED A DEFECTIVE DOWNSTREAM OCCLUSION SENSOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086005 ↗MalfunctionMay 4, 2026Device Sensing Problem
IT WAS REPORTED THAT THE CADD LEGACY PCA PUMP ALARMED WITH NO DISPOSABLE (ND) ALARM AND WOULD NOT RUN. THE PUMP WAS POWERED OFF AND ON AND AN ATTEMPT WAS MADE TO RESTART IT, BUT IT CONTINUED TO ALARM WITH ND AND PUMP WOULD NOT RUN. THE DEVICE STOPPED FUNCTIONING WHILE MEDICATION REMAINED TO BE DELIVERED, RESULTING IN INTERRUPTION OF THERAPY AND POTENTIAL UNDER DELIVERY OF MEDICATION. THE MEDICATION BEING INFUSED WAS ROPIVICAINE WITH PROGRAMMED RATE AT 7 ML PER HOUR, THE REMAINING VOLUME WAS 400 ML, AND THE VOLUME GIVEN WAS 164 ML. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT INJURY/ HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068133 ↗MalfunctionApr 13, 2026Obstruction of Flow
IT WAS REPORTED THAT THE PUMP EXHIBITED AN OCCLUSION ALARM DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865372 ↗MalfunctionApr 13, 2026Obstruction of Flow
IT WAS REPORTED THAT THE PUMP EXHIBITED AN UPSTREAM OCCLUSION ALARM DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860683 ↗MalfunctionApr 1, 2026Failure to Infuse
IT WAS REPORTED THAT THE PATIENT HAD NEEDED ASSISTANCE WITH THE EXTRA DOSE BUTTON, AND ASSISTANCE HAD BEEN PROVIDED. THE DOSE BUTTON HAD NOT FUNCTIONED. THE PUMP SETTINGS HAD BEEN CONFIRMED, AND THE EXTRA DOSE HAD BEEN PROGRAMMED FOR 4 ML EVERY 30¿MINUTES, WITH 0 DOSES GIVEN AND 0 ATTEMPTS RECORDED. AN ATTEMPT HAD BEEN MADE TO POWER THE PUMP OFF AND ON AGAIN, BUT THE DOSE BUTTON STILL DID NOT WORK. THE PATIENT HAD BEEN INSTRUCTED TO TAKE ANY ORAL MEDICATION AVAILABLE TO HER IF ADDITIONAL PAIN CONTROL WAS NEEDED. THERE WAS NO INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757303 ↗MalfunctionMar 13, 2026No Flow
IT WAS REPORTED THAT THE PUMP WOULD NOT RUN AND NEEDED TO BE CHECKED. THERE WAS NO INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592718 ↗MalfunctionMar 6, 2026Failure to Infuse
THE DEVICE DISPLAYED ERROR 1870 (MOTOR PROBLEM) AND (FOREIGN OBJECT BETWEEN GEARS AND LOOSE PLUG CONTACTS). THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532888 ↗MalfunctionMar 5, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP DISPLAYED THE LAST ERROR CODE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523052 ↗
Other Pump, infusion, pca devices
- Alaris 8120Carefusion 303, Inc. · Pump, infusion, pca2 recalls4 deaths14,640 reports
- CADD 21-2111-0402-51Icu Medical, Inc. · Pump, infusion, pca4 recalls1,535 reports
- CADD 21-2111-0300-01Icu Medical, Inc. · Pump, infusion, pca1 recall1,116 reports
- Alaris™ PCA Module, Model 8120Carefusion 303, Inc. · Pump, infusion, pca2 recalls1 death917 reports
- Nimbus II PlusInfutronix LLC · Pump, Infusion, Pca1 recall1 death800 reports
- CADD 21-2112-0300-01Icu Medical, Inc. · Pump, infusion, pca1 recall406 reports
- Nimbus II PainPROInfutronix LLC · Pump, Infusion, Pca2 recalls186 reports
- CADD 21-2111-0402-51LIcu Medical, Inc. · Pump, infusion, pca3 recalls127 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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