CADD 21-7450-24Recalls & 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 infusion pump delivers IV medication, often using a disposable syringe cartridge. The 28 reports mostly describe cartridge and pump trouble: cartridges that stick or are hard to fill, cartridges that stay partly full so the infusion stops, alarms for blockage or service, and leaks at the site. No deaths and no injuries are reported. There are no recalls naming this device, and no reports came in during the last 12 months or the 12 before that.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10610586028694), received between Dec 26, 2019 and Aug 3, 2023 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (11 reports).
2 other recalls cover devices cleared under the same FDA submission (K051568); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Device Alarm System11
- Insufficient Flow or Under Infusion5
- Infusion or Flow Problem3
- Leak/Splash3
- Fluid/Blood Leak2
- Mechanical Jam2
- Physical Resistance/Sticking2
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information11
- No Patient Involvement2
- Headache1
- Hyperventilation1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2023Short Fill; Short Fill
IT WAS REPORTED THAT THE DISPOSABLE WAS HARD TO WORK WITH BY THE PATIENT. THE PATIENT CALLED SAYING SOME OF THE DISPOSABLES ARE FINE AND OTHER ARE HARD TO PULL OUT THE SYRINGE. PATIENT HAS BEEN THROWING THEM AWAY BECAUSE OF BEING UNABLE TO FILL WITH MEDICATION. THE FAULT OCCURRED WHILE IN USE WITH THE PATIENT. THE PRODUCT ISSUE DIDN'T CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY. THE PATIENT WAS ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455508 ↗MalfunctionAug 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED BY THE PATIENT THAT SOME OF THE 3ML SYRINGES CARTRIDGE FROM LAST SHIPMENT ARE STICKING AND IT WAS VERY HARD OR NOT POSSIBLE TO USE THEM TO DRAW MEDICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 17447393 ↗MalfunctionApr 21, 2023Device Alarm System; Device Alarm System
IT WAS REPORTED THE PUMP ALARMED AN ERROR MESSAGE CALL FOR SERVICE WHILE PATIENT WAS HOSPITALIZED DUE TO PREVIOUSLY REPORTED MS3 PUMP ISSUE, PATIENT IS ON FLOLAN. PATIENT COMPLAINS OF MIGRAINES.
Patient problems: Headache
MAUDE report 16784198 ↗MalfunctionApr 19, 2023Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem; Physical Resistance/Sticking
IT WAS REPORTED THE DISPOSABLES WERE ROUGH AND WERE GETTING STUCK. ANOTHER ONE WAS USED TO CONTINUE THE INFUSION. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16768471 ↗MalfunctionMar 21, 2023Device Alarm System; Device Alarm System
IT WAS REPORTED THE CARTRIDGE CAUSED A BLOCKAGE ALARM ON THE PUMP DURING THE LOADING PROCESS. DURING TROUBLESHOOTING, PATIENT BECAME ANXIOUS WAS HYPERVENTILATING. HER MOM TURNED HER OXYGEN UP BY 1 LITER AND SYMPTOM RESOLVED. NO FURTHER DETAILS PROVIDED.
Patient problems: Hyperventilation
MAUDE report 16586469 ↗MalfunctionDec 9, 2022Device Alarm System; Device Alarm System
ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON 15-DEC-2022 VIA EMAIL AND ATTACHED TO THE COMPLAINT OBJECT. THE DATE OF EVENT AND PATIENT IDENTIFIER INFORMATION HAS BEEN RECEIVED AND UPDATED INTO THE FILE. THE REPORTED EVENT DID OCCUR WHILE IN USE WITH A PATIENT. THE EVENT DID NOT RESULT IN ANY PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. THE ISSUE IS NOW REPORTED AS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15951697 ↗MalfunctionSep 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE WAS LEAKING. PATIENT EXPERIENCED SHORTNESS OF BREATH AND PAIN AT THE SITE. PATIENT HAD BEEN RELEASED FROM HOSPITAL PRIOR. THERE WAS NO PATIENT INJURY REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15446632 ↗MalfunctionJul 8, 2022Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT A PATIENT REPORTED CHANGING A CARTRIDGE. THEN, LAST NIGHT THE PUMP WAS CHECKED AND REALIZED THAT THE CARTRIDGE WAS STILL ABOUT 90%FULL, PATIENT RESTARTED HER INFUSION AT HER MAINTENANCE DOSE RATE OF 0.028 ML/HR (37 NKM) AND WENT TO BED. PATIENT WOKE UP THIS MORNING FEELING TERRIBLE. SHE WAS PREVIOUSLY TOLD BY MEDIC IF SOMETHING LIKE THIS OCCURRED, SHOULD REDUCE THE INFUSION RATE BY HALF AND INCREASE BY 0.002 ML/HR EVERY DAY AS TOLERATED UNTIL SHE GETS BACK UP TO HER MAINTENANCE DOSE. PATIENT ALSO HAD NOT CHANGED HER CARTRIDGE AFTER 72 HOURS BECAUSE SHE THOUGHT IF PUMP WASN'T RUNNING SHE WOULDN'T HAVE TO.
Patient problems: Insufficient Information
MAUDE report 14956836 ↗MalfunctionJun 1, 2022Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
IT WAS REPORTED THE DEVICE ALARMED -CARTRIDGE REMOVED, PRESS OK TO BEGIN LOAD PROCESS- MID INFUSION, THEN ONCE RESTARTED, RAN FOR 1 MINUTE AND THEN ALARMED -REVIEW DELIVERY PROGRAM-. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14566371 ↗MalfunctionMay 25, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE 3ML CARTRIDGE THAT WAS LOADED INTO THE MS3 PUMP ALARMED AFTER PRESSING ?START" TO FILL TUBING, AND JUMPED BACK TO LOAD CARTRIDGE SCREEN EVEN THOUGH THE CARTRIDGE WAS LOADED AND CHECK MARK WAS IN BOX. SHE TRIED IT IN BOTH PUMPS MULTIPLE TIMES AND ALWAYS THE SAME ISSUE HAPPENED. WHEN SHE USED A NEW CARTRIDGE, IT WORKED FINE IN BOTH PUMPS. NO PATIENT OR CLINICIAN INJURY. NO PATIENT INFORMATION IS REQUESTED/ ENTERED AS THIS IS CONSIDERED CONFIDENTIAL IN (B)(6)",
Patient problems: Insufficient Information
MAUDE report 14493682 ↗MalfunctionMar 19, 2022Device Alarm System; Infusion or Flow Problem; Device Alarm System; Infusion or Flow Problem
PER EMAIL (MEDWATCH REPORT #MW5106706, REPORT DATE: (B)(6) 2022): INBOUND ; HUSBAND REPORTS CADD MS3 PUMP ALARMED EMPTY WHEN IT STILL HAD 1.0 ML LEFT IN CARTRIDGE, CARTRIDGE LOT# 10210 720. REPLACEMENT PUMPS SENT. NO FURTHER DETAILS PROVIDED. .
Patient problems: Insufficient Information
MAUDE report 13827542 ↗MalfunctionMar 19, 2022Device Alarm System; Insufficient Flow or Under Infusion; Device Alarm System; Insufficient Flow or Under Infusion
PER MEDWATCH MW5106541: INBOUND; PT REPORTS SHE HAS NOTICED APPROX 04 ML TREPROSTINIL LEFT IN HER CADD MS3 SYRINGES WHEN PUMP ALERTS TIME TO CHANGE AND/ OR EMPTY. NO LOT NUMBERS AVAILABLE AND PT WILL START HAVING HER WRAPPERS AND NOTIFY OF FURTHER ISSUES. NO FURTHER DETAILS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13827168 ↗MalfunctionMar 18, 2022Device Alarm System; Insufficient Flow or Under Infusion; Device Alarm System; Insufficient Flow or Under Infusion
PER MEDWATCH MW5106541: INBOUND; PT REPORTS SHE HAS NOTICED APPROX 04 ML TREPROSTINIL LEFT IN HER CADD MS3 SYRINGES WHEN PUMP ALERTS TIME TO CHANGE AND/ OR EMPTY. NO LOT NUMBERS AVAILABLE AND PT WILL START HAVING HER WRAPPERS AND NOTIFY OF FURTHER ISSUES. NO FURTHER DETAILS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13808548 ↗MalfunctionMar 18, 2022Device Alarm System; Infusion or Flow Problem; Device Alarm System; Infusion or Flow Problem
PER EMAIL (MEDWATCH REPORT #MW5106706, REPORT DATE: (B)(6) 2022): INBOUND; HUSBAND REPORTS CADD MS3 PUMP ALARMED EMPTY WHEN IT STILL HAD 1.0 ML LEFT IN CARTRIDGE, CARTRIDGE LOT# 10210720. REPLACEMENT PUMPS SENT. NO FURTHER DETAILS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13808167 ↗MalfunctionFeb 28, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE PATIENT THAT THE SYRINGE PLUNGER WILL NOT SLIDE UP AND DOWN SMOOTHLY AND EXTREMELY DIFFICULT TO GET IT STARTED, BUT ONCE IT GETS STARTED IT HALFWAY WORKS. THE PATIENT STATES THAT ABOUT .2 TO .25 MLS LEFT IN THE CARTRIDGE RECEIVED. PLUNGER IS SO TIGHT THAT WHEN PUSHED BY HAND IT WON'T BUDGE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13623267 ↗MalfunctionFeb 28, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE PATIENT THAT THE SYRINGE PLUNGER WILL NOT SLIDE UP AND DOWN SMOOTHLY AND EXTREMELY DIFFICULT TO GET IT STARTED, BUT ONCE IT GETS STARTED IT HALFWAY WORKS. THE PATIENT STATES THAT ABOUT .2 TO .25 MLS LEFT IN THE CARTRIDGE RECEIVED. PLUNGER IS SO TIGHT THAT WHEN PUSHED BY HAND IT WON'T BUDGE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13622732 ↗MalfunctionFeb 24, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED PER EMAIL (MEDWATCH REPORT #MW5106540, REPORT DATE: (B)(6) 2021) THAT MS3 PUMP FOR GENERIC TREPROSTINIL ALARMS LOW VOLUME, BUT SYRINGE STILL HAS 0.4 ML REMAINING. PATIENT REQUESTS THAT BOTH PUMPS ARE REPLACED AS WELL AS REPORTING PRODUCT COMPLAINT FOR CARTRIDGE. NO FURTHER DETAILS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13595363 ↗MalfunctionFeb 24, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
PER EMAIL (MEDWATCH REPORT # MW5106294; IT WAS REPORTED THAT CADD- PUMP KIT, CADD -MS3 PUMP ALARMS LOW VOLUME EARLY (UNDER-DELIVERY). NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13591954 ↗MalfunctionFeb 18, 2022Device Alarm System; Device Alarm System
(2/2, REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING CARTRIDGE). INFORMATION WAS RECEIVED VIA MEDWATCH REPORT #MW5106292, REPORT DATE: (B)(6) 2021 THAT REPEATED ISSUE WITH MS3 PUMP ALARMING LOW VOLUME WITH TREPROSTINIL STILL LEFT IN CARTRIDGE, WAS EXPERIENCED. CARTRIDGE LOT UNAVAILABLE. NO FURTHER DETAILS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13562898 ↗MalfunctionFeb 16, 2022Difficult to Open or Close; Difficult to Open or Close
PER EMAIL (MEDWATCH REPORT #MW5106290: IT WAS REPORTED THAT CADD MS 3 SYRINGES ARE EXTREMELY HARD TO PUSH AND PULL PLUNGER. NO PATIENT OR CLINICIAN INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13545975 ↗MalfunctionDec 6, 2021Leak/Splash; Insufficient Flow or Under Infusion; Leak/Splash; Insufficient Flow or Under Infusion
INFORMATION WAS RECEIVED INDICATING A SMITHS MEDICAL, CADD-MS 3 CARTRIDGE, WAS LEAKING BETWEEN THE CARTRIDGE AND TUBING OF THE PUMP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12932459 ↗MalfunctionNov 8, 2021Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED REGARDING A CADD MS3 CARTRIDGE. IT WAS REPORTED THAT THE PUMP IN THE MIDDLE OF THE NIGHT, THE REMODULIN SOMEHOW LEAKED, AND BY THE MORNING THE CARTRIDGE WAS COMPLETELY EMPTY. PATIENT WAS PALE AS SHE WOULD GET WHEN OFF OF REMODULIN FOR AN EXTENDED PERIOD OF TIME. THE LINE WAS INTACT PROPERLY AND THE CARTRIDGE WAS INTACT. PATIENT HAD A BACKUP PUMP AND WAS ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION. THERE WAS NO PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THESE OCCURRENCES. NO FURTHER DETAILS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12775609 ↗MalfunctionNov 2, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
INFORMATION WAS RECEIVED REGARDING A CADD MS3 CARTRIDGE. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FROM (B)(6) 2021. PATIENT HAD FALLEN AND LOST MOBILITY, THEREFORE HAD TO COMPLETE BACK SURGERY. PATIENT'S DAUGHTER NOTED THAT THE CADD MS3 PUMP WOULD KEEP FREEZING ON THE LOAD SCREEN AND FILL TUBING SCREEN, WHICH WAS RESOLVED WHEN A DIFFERENT CADD MS3 BRAND SYRINGE WAS USED. NO SUPPLY OR LOT NUMBER WAS AVAILABLE AS IT WAS DISCARDED. TROUBLESHOOTING WAS SUCCESSFUL. DRUG NAME BEING ADMINISTERED WAS REMODULIN 5MG/ML AT 31NG/KG/ MI N. NO FURTHER DETAILS PROVIDED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 12734324 ↗MalfunctionOct 25, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE DISPOSABLE LEAKED WHEN THEY DISCONNECTED THE BOTTOM PORTION TO INSERT INTO PUMP, MEDICATION STARTED TO LEAK OUT FROM THE BOTTOM OF THE CARTRIDGE. THIS OCCURRED WHILE IN USE ON THE PATIENT. NO PATIENT DEATH OR SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12693895 ↗MalfunctionSep 27, 2021Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD MS3 CARTRIDGE EXHIBITED A LOAD CASSETTE ERROR, AFTER A RUBBER GASKET WAS LOST FROM THE TOP OF THE CAP OF THE SYRINGE. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12532856 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051568. One submission often covers many models, so check the product and lot details in each record.
- Z-1621-2008 · Mar 7, 2008 · TerminatedCADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used m
- Z-1641-2008 · Feb 22, 2008 · TerminatedCADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medicatio
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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