CADD 21-7345-24Recalls & 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 CADD administration set is the tubing and bag used to deliver IV medicines at home or in care settings. The 50 reports mostly describe leaking or cracking of the tubing — leaks at the port or elbow, small cracks above the clamp — plus sets arriving already damaged, and alarm or flow problems that sometimes went unheard. One injury was reported and no deaths. There have been more reports in the past 12 months (7) than the12 months before (1), 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
- 49
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 15019517191714), received between Sep 1, 2020 and May 8, 2026 — classified as 1 injury, 48 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).
3 other recalls cover devices cleared under the same FDA submission (K031361); 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak17
- Device Damaged Prior to Use10
- Device Alarm System7
- Leak/Splash7
- Break3
- Insufficient Flow or Under Infusion3
- Disconnection2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information9
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Fluid/Blood Leak
IT WAS REPORTED A LEAKAGE WAS OBSERVED ABOVE THE AIR FILTER AT THE ELBOW CONNECTION. ALL AFFECTED TUBING ORIGINATED FROM THE SAME LOT AND WAS BEING USED AS PART OF A CUSTOM HYDRATION SETUP. THE PATIENT RECEIVED CUSTOM IV HYDRATION THERAPY CONSISTING OF AN ISOTONIC SODIUM ACETATE SOLUTION (150 MEQ IN 1.2 L OF STERILE WATER) SUPPLEMENTED WITH POTASSIUM CHLORIDE, MAGNESIUM SULFATE, CALCIUM GLUCONATE, AND ZINC. THERE WAS A PATIENT INVOLVEMENT BUT NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130050 ↗MalfunctionFeb 13, 2026Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A TREND OF PRODUCT BREAKAGE WITH THE CADD ADMINISTRATION SET. SEVERAL SETS WERE CRACKED ABOVE THE CLAMP CAUSING SMALL LEAKAGE. PRODUCTS WERE NOT SAVED FOR RETURN. NO HARM TO THE PATIENTS HOWEVER TREATMENT WAS DELAYED DUE TO THE STOPPING OF INFUSION TO OBTAIN NEW SET AND PREPARATION OF REPLACEMENT MEDICATION DOSE. THE EVENT OCCURRED DURING INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333782 ↗MalfunctionJan 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAKING AT PORT. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093328 ↗MalfunctionJan 13, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAKING AT PORT. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060328 ↗MalfunctionJan 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976152 ↗MalfunctionJan 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976146 ↗MalfunctionAug 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CADD TUBING WAS LEAKING FROM THE PORT DURING COMPOUNDING AND INFUSIONS. THE ISSUE INVOLVES A BREAK IN THE LINE NEAR THE ACCESS PORT. THERE WAS A DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22691132 ↗MalfunctionOct 15, 2024Defective Alarm; Air/Gas in Device; Defective Alarm; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AIR IN LINE. PER REPORTER, AFTER ABOUT 42 HOURS THE PATIENT ARRIVED BACK AT CLINIC. THERE WAS A SIGNIFICANT AMOUNT OF AIR NOTED BETWEEN THE PUMP AND FILTER. THE BAG STILL HAD ~300 ML IVF LEFT, AND THE PUMP CONTINUED TO RUN WITH NO ALARM THAT THERE WAS AIR IN LINE. THERE WAS NO AIR BETWEEN FILTER AND PATIENT, SO AIR DID NOT APPEAR TO HAVE REACHED PATIENT. THEY STOPPED THE PUMP, NOTIFIED LIP, PHARMACY. THE PUMP WAS RETURNED TO THE PHARMACY. A NEW PUMP/IVF BAG WAS CONNECTED TO THE PATIENT WITH INSTRUCTIONS TO KEEP THE PUMP AT/ABOVE HEART LEVEL AND TO STOP PUMP IMMEDIATELY IF AIR WAS NOTED IN THE TUBING. THE PATIENT SHOWED NO SYMPTOMS OF DISTRESS/AIR EMBOLISM WHILE IN PACC. THE EVENT OCCURRED AT THE PATIENT'S HOME AND WAS OPERATED BY A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451005 ↗MalfunctionFeb 22, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DISPOSABLE CAUSED THE DEVICE TO EXHIBITED AN AIR IN LINE ERROR. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18759315 ↗MalfunctionNov 30, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE CASSETTE EXHIBITED LEAKAGE AT THE TUBING AND SPIKE. HOLES WERE PRESENT IN THE TUBING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242096 ↗MalfunctionNov 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING APPEARED TO BE LEAKING AT THE ATTACHMENT SITE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 18155339 ↗MalfunctionNov 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING APPEARED TO BE LEAKING AT THE ATTACHMENT SITE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 18155336 ↗MalfunctionOct 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT THE LINE WAS LEAKING; SPLIT TUBING UNDER PLASTIC MOUNT IN THE UNKNOWN SET. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17904712 ↗MalfunctionOct 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT THE LINE WAS LEAKING; SPLIT TUBING UNDER PLASTIC MOUNT IN THE UNKNOWN SET. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17904664 ↗MalfunctionFeb 28, 2023Device Alarm System; Increase in Pressure; Device Alarm System; Increase in Pressure
IT WAS REPORTED THAT THE ADMINISTRATION SET HAD A HIGH VOLUME THAT HAS A FILTER. PUMP WAS STUCK ABOUT THE SAME TIME EVERY NIGHT AND IT WOULD COME UP WITH A DOWNSTREAM OCCLUSION ERROR, EVEN AFTER CLEARING THE OCCLUSION, THEY'RE STILL HAVING ISSUE ALMOST DAILY WITH THE ADMINISTRATION SET. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456627 ↗MalfunctionFeb 10, 2023Device Alarm System; Insufficient Flow or Under Infusion; Device Alarm System; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE PUMP BEEPED AT THE 24 HOUR TIME WITH "INFUSION COMPLETED" IN THE DISPLAY. WHEN THE BAG WAS OPENED, THE RESERVOIR WAS STILL FULL. THERE WERE NO OTHER ALARMS OR BEEPING OVER THE 24 HOURS. THE PATIENT WAS SEEN AT THE LOCAL HOSPITAL FOR CARE. THE RN ASSESSED THAT THERE WAS ONE CLAMP ON THE INFUSION SET AND IT WAS OPEN. OBSERVATION OF THE SET INDICATED THAT THE MEDICATION HAD INFUSED FOR AT LEAST 24 MINUTES AS THE TUBING WAS VISUALLY COLORED.
Patient problems: Insufficient Information
MAUDE report 16351973 ↗MalfunctionSep 26, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THE LINE CAME AWAY FROM THE WHITE LUER CONNECTION SECTION. THERE WAS NO PATIENT INJURY, AND NO MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484773 ↗MalfunctionSep 6, 2022Break; Break
IT WAS REPORTED THAT THE SAME INCIDENT OCCURRED ON TWO SEPARATE DAYS WHERE THE DEVICE LINE WAS DISCONNECTING FROM THE WHITE LUER OF THE ADMINISTRATION SET. THIS INCIDENT OCCURRED WITH TWO PATIENTS. NO MEDICAL INTERVENTION WAS NEEDED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15361779 ↗MalfunctionSep 2, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THE LINE DISCONNECTED FROM THE WHITE LUER OF THE ADMIN SET. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15351322 ↗MalfunctionAug 16, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EPOCH. IT WAS REPORTED THAT THE DRUG DIDN'T INFUSE FROM (B)(6) 2022 TO (B)(6) 2022. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15233829 ↗MalfunctionAug 16, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EPOCH. FIELD NURSE REPORTED THAT HALF OF THE BAG OF EPOCH WAS NOT INFUSED AT THE TIME OF BAG CHANGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15232683 ↗MalfunctionJun 22, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PATIENT'S BAG LEAKED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14776360 ↗MalfunctionJun 13, 2022Device Alarm System; Failure to Deliver; Obstruction of Flow; Device Alarm System; Failure to Deliver; Obstruction of Flow
IT WAS REPORTED THAT THE PUMP WAS COUNTING DOWN VOLUME IN MILLILITERS, BUT THE BAG WAS COMPLETELY FULL. PUMP EVENT LOG WAS ALSO ALARMING DOWNSTREAM OCCLUSIONS, "ADMIN SET LATCHED" AND THE PUMP WAS NOT INFUSING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14681849 ↗MalfunctionMar 23, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USAGE THE DEVICE LEAKED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869580 ↗MalfunctionMar 23, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USAGE THE DEVICE LEAKED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869419 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.
- Z-0962-2023 · Dec 9, 2022 · Open, ClassifiedCADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
- Z-0148-2022 · Jul 14, 2020 · TerminatedCADD Administration Sets, Model #21-7346-24
- Z-2589-2017 · May 15, 2017 · TerminatedCADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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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