CADD 21-7339-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical CADD administration set delivers medication through an infusion pump. Reports mostly describe too little or no medication flowing, along with leaks and difficulty preparing the set. There are 25 reports, with no deaths or injuries. One open recall, started in December 2022, concerns possible underdelivery from tubing blockages and false “No Disposable Attached” alarms.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10610586027307), received between Nov 21, 2018 and Oct 20, 2021 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (12 reports).
1 FDA recall record name this device's identifier, 1 still open.
5 other recalls cover devices cleared under the same FDA submission (K040636); 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.
Recalls naming this device
- Dec 9, 2022Class IOpen, Classified
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Z-0963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Flow or Under Infusion12
- Infusion or Flow Problem7
- Leak/Splash7
- Device Difficult to Setup or Prepare6
- No Flow3
- Connection Problem1
- Fluid/Blood Leak1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient12
- No Information8
- Underdose3
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2021Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS NOTED TO BE UNDER DELIVERING. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12667076 ↗MalfunctionNov 26, 2020Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem
INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SET, LEAKING WAS NOTICED. IT WAS REPORTED THAT LEAKING DURING A BOLUS ADMINISTRATION OF AN EPIDURAL PROCEDURE AND HAD TO RE-DONE DUE TO POSSIBLE CONTAMINATION. NO REPORTED ADVERSE EFFECT OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10909789 ↗MalfunctionJul 7, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET DID NOT INFUSE EPIDURAL MEDICATION. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 10241070 ↗MalfunctionJul 7, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET DID NOT INFUSE EPIDURAL MEDICATION. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 10241067 ↗MalfunctionJun 24, 2020Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - FLOW STOP IS NOT ABLE TO BE PRIMED. THE PUMP INDICATES THAT 10 CC WAS PRIMED. THERE'S ALSO SUSPICION THAT THE TUBE IS LEAKING. THE INFUSION WAS FOR ROPIVACAINE AND FENTANYL. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10192922 ↗MalfunctionJun 24, 2020Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - FLOW STOP IS NOT ABLE TO BE PRIMED. THE PUMP INDICATES THAT 10 CC WAS PRIMED. THERE'S ALSO SUSPICION THAT THE TUBE IS LEAKING. THE INFUSION WAS FOR ROPIVACAINE AND FENTANYL. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10192902 ↗MalfunctionJun 24, 2020Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - FLOW STOP IS NOT ABLE TO BE PRIMED. THE PUMP INDICATES THAT 10 CC WAS PRIMED. THERE'S ALSO SUSPICION THAT THE TUBE IS LEAKING. THE INFUSION WAS FOR ROPIVACAINE AND FENTANYL. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10190255 ↗MalfunctionJun 24, 2020Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - FLOW STOP IS NOT ABLE TO BE PRIMED. THE PUMP INDICATES THAT 10 CC WAS PRIMED. THERE'S ALSO SUSPICION THAT THE TUBE IS LEAKING. THE INFUSION WAS FOR ROPIVACAINE AND FENTANYL. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10190240 ↗MalfunctionJun 24, 2020Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - FLOW STOP IS NOT ABLE TO BE PRIMED. THE PUMP INDICATES THAT 10 CC WAS PRIMED. THERE'S ALSO SUSPICION THAT THE TUBE IS LEAKING. THE INFUSION WAS FOR ROPIVACAINE AND FENTANYL. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10190218 ↗MalfunctionJun 24, 2020Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare
INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - FLOW STOP IS NOT ABLE TO BE PRIMED. THE PUMP INDICATES THAT 10 CC WAS PRIMED. THERE'S ALSO SUSPICION THAT THE TUBE IS LEAKING. THE INFUSION WAS FOR ROPIVACAINE AND FENTANYL. THERE WERE NO ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10190108 ↗MalfunctionMay 22, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS NOT DELIVERING MEDICATION. THE REPORTER INDICATED THAT PER NURSE, THE PATIENT HAD NOT RECEIVED ANY MEDICATION FOR HOURS. SUBSEQUENTLY, THE TUBING WAS CHANGED OUT THEN MEDICATION WAS ABLE TO BE INFUSED WITHOUT AN ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10082372 ↗MalfunctionMay 21, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS NOT DELIVERING MEDICATION. THE REPORTER INDICATED THAT PER NURSE, THE PATIENT HAD NOT RECEIVED ANY MEDICATION FOR HOURS. SUBSEQUENTLY, THE TUBING WAS CHANGED OUT THEN MEDICATION WAS ABLE TO BE INFUSED WITHOUT AN ISSUE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10080244 ↗MalfunctionApr 2, 2020Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, THE PUMP INDICATED THAT THE BAG WAS EMPTY BUT THERE WAS STILL 25-40 ML OF MEDICATION IN THE EPIDURAL BAG. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 9916140 ↗MalfunctionMar 31, 2020No Flow; No Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ADMINISTRATION SET WAS IMPLICATED IN A MEDICATION NOT BEING DELIVERED TO THE PATIENT. THE PATIENT WAS NOT GETTING COMFORTABLE. IT WAS DISCOVERED THAT NO MEDICATION WAS BEING DELIVERED BY VIEWING THE MEDICATION CONTAINER DESPITE THE PUMP INDICATING MEDICATION WAS BEING DELIVERED. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.
Patient problems: Underdose
MAUDE report 9908435 ↗MalfunctionMar 31, 2020No Flow; No Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ADMINISTRATION SET WAS IMPLICATED IN A MEDICATION NOT BEING DELIVERED TO THE PATIENT. THE PATIENT WAS NOT GETTING COMFORTABLE. IT WAS DISCOVERED THAT NO MEDICATION WAS BEING DELIVERED BY VIEWING THE MEDICATION CONTAINED DESPITE THE PUMP INDICATING MEDICATION WAS BEING DELIVERED. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.
Patient problems: Underdose
MAUDE report 9908429 ↗MalfunctionMar 31, 2020No Flow; No Flow
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ADMINISTRATION SET WAS IMPLICATED IN A MEDICATION NOT BEING DELIVERED TO THE PATIENT. THE PATIENT WAS NOT GETTING COMFORTABLE. IT WAS DISCOVERED THAT NO MEDICATION WAS BEING DELIVERED BY VIEWING THE MEDICATION CONTAINED DESPITE THE PUMP INDICATING MEDICATION WAS BEING DELIVERED. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.
Patient problems: Underdose
MAUDE report 9908426 ↗MalfunctionDec 16, 2019Connection Problem; Connection Problem
INFORMATION RECEIVED A SMITHS MEDICAL CADD ADMINISTRATION SET WHEN SPIKED IN THE EPIDURAL BAG WOULD NOT PRIME. UPON ATTACHING DEVICE TO MACHINE A" ALARM ERROR MESSAGE" WAS RECEIVED.. SEVERAL ATTEMPTS MADE TO ATTACH DEVICE AND WERE UNSUCCESSFUL, SO THEREFORE NEW TUBING WAS IMPLEMENTED AND THE ADMINISTRATION SET WAS SUCCESSFULLY ATTACHED. NO PATIENT ADVERSE EVENTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9474126 ↗MalfunctionDec 2, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS IN USE WITH A CADD HCPA PUMP WHEN THE MEDICATION WOULD NOT INFUSE. THE REPORTER STATED NO ALARMS WENT OFF ON THE PUMP. IT WAS ALSO REPORTED ONCE THE OPERATOR CHANGED THE TUBING, THE PUMP FUNCTIONED PROPERLY, BUT DURING ANOTHER TIME THE USER CHANGED THE PUMP AND THE INFUSION SYSTEM FUNCTIONED PROPERLY. THEREFORE, THE ANESTHESIOLOGIST PUSHED THE PAIN MEDICATION AND DID NOT USE THE PUMP. NO ADDITIONAL TREATMENT WAS NEEDED FOR THE PATIENT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9398841 ↗MalfunctionSep 25, 2019Infusion or Flow Problem; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SET, PUMP WAS NOT INFUSING THROUGH THE TUBING DESPITE THE EPI PUMP APPEARING TO BE FUNCTIONING NORMALLY. IT WAS REPORTED THAT THE PUMP WAS STARTED AS PER USUAL AND AFTER ABOUT 2 HOURS THE PATIENT BECAME UNCOMFORTABLE AND USED HER PCEA X3, ANESTHESIA RESIDENT CALLED FOR TOP UP. THE TOP UP WAS GIVEN AND PATIENT WAS COMFORTABLE FOR ABOUT 45 MINUTES AND THEN USED HER PCEA AGAIN. UPON USE OF THE PCEA, THE EPI PUMP ALARMED, LOW VTBI AND THE NURSE TRIED TO CHANGE THE BAG WHEN SHE NOTICED THAT THE BAG WAS STILL FULL. ACCORDING TO THE REPORT IT APPEARED AS THROUGH THE CARTRIDGE ATTACHED TO THE TUBING WAS NOT FUNCTIONING PROPERLY. SUBSEQUENTLY, THE TUBING WAS CHANGED, AND THE PUMP AND TUBING BEGAN TO FUNCTION NORMALLY. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119473 ↗MalfunctionSep 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.
Patient problems: No Information
MAUDE report 8960218 ↗MalfunctionSep 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.
Patient problems: No Information
MAUDE report 8960217 ↗MalfunctionSep 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.
Patient problems: No Information
MAUDE report 8958144 ↗MalfunctionSep 3, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.
Patient problems: No Information
MAUDE report 8958134 ↗MalfunctionSep 2, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A LIST OF INFUSION SETS WAS PROVIDED BY PRODUCT DISTRIBUTOR. IT IS UNCLEAR IF ANY PATIENT EVENTS OCCURRED OR ANY TEST FAILURES OCCURRED WITH THE DEVICES LISTED. THE DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM WHETHER THESE SETS DID NOT MEET WITH ACCURACY SPECIFICATIONS OR IF THE LIST PROVIDED WAS RELATED TO EXISTING FILES ALREADY REPORTED. SEE RELATED FILES 3012307300-2019-04572 THROUGH 3012307300-2019-04591.
Patient problems: No Information
MAUDE report 8953970 ↗MalfunctionNov 21, 2018Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT THE CADD ADMINISTRATION SET FOR A PUMP TUBING WAS LEAKING AT THE FILTER. NO REPORTED ADVERSE EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8097001 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040636. One submission often covers many models, so check the product and lot details in each record.
- Z-2522-2025 · Aug 6, 2025 · Open, ClassifiedSmiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
- Z-1767-2017 · Mar 17, 2017 · TerminatedCADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
- Z-1831-2016 · Apr 22, 2016 · TerminatedCADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24
- Z-1286-2015 · Feb 2, 2015 · TerminatedCADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
- Z-0879-2008 · Dec 14, 2007 · TerminatedSmiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Pa
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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 · each recall links to the FDA recall notice
- 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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