CADD 21-7309-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical CADD infusion set is tubing used with a CADD pump to deliver medicine. Most of the 82 reports describe fluid leaking from the bladder seam or cassette, and some describe tubing blockages. The reports include no injuries and no deaths. There are 2 open recalls, both over tubing blockages that can cause too little medicine to be delivered and false alarms saying no set is attached.
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
- 80
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10610586032387), received between Apr 13, 2018 and Sep 16, 2026 — classified as 80 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (31 reports).
2 FDA recall records name this device's identifier, 2 still open.
9 other recalls cover devices cleared under the same FDA submission (K081156); 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
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-0964-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak31
- Leak/Splash26
- Defective Device15
- Device Alarm System3
- Failure to Infuse3
- Insufficient Flow or Under Infusion3
- Manufacturing, Packaging or Shipping Problem3
- Obstruction of Flow3
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- No Patient Involvement6
- Insufficient Information4
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792580 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739906 ↗MalfunctionJul 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769244 ↗MalfunctionJul 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769238 ↗MalfunctionJun 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT INSPECTION OF THE CADD CASSETTE REVEALED THAT THE LEAKAGE ORIGINATED FROM INSIDE THE SEALED HARD PLASTIC CASE RATHER THAN FROM THE TUBING. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628170 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE SEAM OF THE BLADDER. IT WAS FOUND OUT UPON LOT RECEIPT OR AFTER DELIVERY. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178499 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE SEAM OF THE BLADDER. PER REPORTER, THE ISSUE WAS IDENTIFIED ON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176759 ↗MalfunctionMar 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT CADD MEDICATION CASSETTE RESERVOIR WAS LEAKING. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606959 ↗MalfunctionMar 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT CADD MEDICATION CASSETTE RESERVOIR WAS OBSERVED LEAKING AT THE UPPER CORNER OF THE BLADDER ALONG THE SEAM NEAR THE BLUE FLOW-STOP CLIP. THE UNIT CONTAINED FENTANYL 2 MCG/ML-ROPIVACAINE HCL 0.2% PF 200 ML NS. THE WHITE PINCH CLAMP ON THE PIGTAIL TUBING AND THE RED LUER-LOCK CAP WERE SECURED AS REQUIRED. NO DAMAGE WAS OBSERVED TO THE OUTER CADD CASE OR TUBING. THE LEAK WAS CONFINED TO THE UPPER CORNER OF THE BLADDER NEAR THE BLUE FLOW-STOP CLIP. CADD MEDICATION CASSETTE RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606672 ↗MalfunctionMar 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT CADD MEDICATION CASSETTE RESERVOIR WAS LEAKING. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606665 ↗MalfunctionMar 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT CADD MEDICATION CASSETTE RESERVOIR WAS LEAKING. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606640 ↗MalfunctionMar 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT CADD MEDICATION CASSETTE RESERVOIR WAS LEAKING. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606603 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AT THE END OF THE PREPARATION, A LIQUID LEAK WAS DETECTED IN THE PRODUCT. THE EVENT OCCURRED IN A PREPARATION ROOM, AND THE PRODUCT WAS PLACED IN QUARANTINE AFTER THE INCIDENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369063 ↗MalfunctionNov 10, 2025Contamination; Contamination
IT WAS REPORTED THAT A SMALL HAIR WAS FOUND INSIDE THE END OF THE FILLING PORT. THE ISSUE WAS DISCOVERED DURING THE FILLING OF THE CASSETTE IN THE CLEANROOM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513056 ↗MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CASSETTE CONTAINING FENTANYL 2 MCG/ML-ROPIVACAINE WAS FOUND TO BE LEAKING DURING THE RECEIVING PROCESS. PER REPORTER THE BAG WAS FOUND TO BE ¿WET AND DRIPPING ON THE PHARMACIST¿ WHEN THE BAG CONTAINING THE CASSETTE WAS BEING PLACED INTO THE STORAGE SYSTEM FOR CONTROLLED SUBSTANCES. NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THE ALLEGED CONTACT. THE REPORTER STATED THAT THE CLAMP ON THE CASSETTE ON THE PIGTAIL TUBING HAD NOT BEEN CLOSED AS REQUIRED, ALTHOUGH THE RED LUER-LOCK CAP HAD BEEN PROPERLY SECURED. IT WAS REPORTED THAT NO PHYSICAL DAMAGE WAS OBSERVED ON THE CASSETTE OR ITS TUBING; HOWEVER, LIQUID WAS OBSERVED INSIDE THE YELLOW CASING. PER REPORTER MANUAL PRESSURE HAD BEEN APPLIED TO THE BLADDER AND A LEAK WAS OBSERVED IN A CORNER OF THE BLADDER ALONG THE SEAM, OPPOSITE THE BLUE FLOW STOP CLIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978576 ↗MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WERE OBVIOUS SIGNS OF LEAKAGE WITH LIQUID WITHIN THE OVERWRAP AND BUBBLE WRAP BAGS. LIQUID WAS OBSERVED INSIDE OF THE YELLOW CASING OF THE CADD SUGGESTING A POTENTIAL BLADDER LEAK. MANUAL PRESSURE WAS APPLIED TO THE BLADDER TO DETERMINE WHETHER THERE WAS A BLADDER LEAK. THERE WAS A LEAKING AT THE UPPER LEFT CORNER OF THE BLADDER ALONG THE SEAM, OPPOSITE OF THE BLUE FLOW STOP CLIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737327 ↗MalfunctionJul 23, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT WHEN THE PUMP HAD AN OCCLUSION, IT MOSTLY OCCURRED DURING A CASSETTE CHANGE, AFTER ONE CASSETTE HAD FINISHED AND A NEW ONE WAS INSERTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579616 ↗MalfunctionJul 23, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT WHEN THE PUMP HAD AN OCCLUSION, IT MOSTLY OCCURRED DURING A CASSETTE CHANGE, AFTER ONE CASSETTE HAD FINISHED AND A NEW ONE WAS INSERTED. IN ADDITION TO THE MAIN PROBLEM, IT WAS ALSO STATED THAT THIS HAS HAPPENED WITH SEVERAL 250 ML CASSETTES (LOT 6070562) AND SEVERAL SOLIS HPCA PUMPS. EVENT OCCURRED AT A HOSPITAL AND WAS WHILE USED IN PATIENT, ALSO NO HARM HAPPENED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579439 ↗MalfunctionJul 16, 2025Obstruction of Flow; Obstruction of Flow
IT WAS SATED THAT THE CASSETTE BLOCKS THE FLOW OF LIQUID. THE INCIDENT OCCURRED BEFORE USE ON THE PATIENT, SPECIFICALLY AT THE TIME OF THE CASSETTE CHANGE. IT HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE TWO AFFECTED CASSETTES WERE RETRIEVED BY THE HOSPITAL PHARMACY (PUI), AND ADDITIONALLY, 4 BOXES CONTAINING 12 UNITS EACH HAVE BEEN PLACED IN QUARANTINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22524389 ↗MalfunctionFeb 21, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THERE WAS A DOWNSTREAM OCCLUSION ON THE FIRST BOLUS. THERE IS PATIENT INVOLVEMENT. THE EVENTS OCCURRED FROM (B)(6) 2024 TO (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432411 ↗MalfunctionJan 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE UNIT WAS OBSERVED TO BE LEAKING AT THE TOP RIGHT CORNER OF THE CADD AT THE JOINT BETWEEN THE TUBING AND THE BLADDER. THE PRODUCT FAULT WAS OBSERVED DURING MARKET PROCESS STAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277668 ↗MalfunctionJan 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE UNIT WAS OBSERVED TO BE LEAKING AT THE TOP RIGHT CORNER OF THE CADD AT THE JOINT BETWEEN THE TUBING AND THE BLADDER. THE PRODUCT FAULT WAS OBSERVED DURING MARKET PROCESS STAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277653 ↗MalfunctionDec 12, 2024Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE CASSETTE CAUSED AN OCCLUSION ALARM. THERE WERE REPORTED THREE INCIDENTS WITH THIS BATCH. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20920596 ↗MalfunctionDec 11, 2024Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE CADD CASSETTE TRIGGERED A DOWNSTREAM OCCLUSION ALARM ON THE PUMP. THE PRODUCT WAS NOT ADMINISTERED TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. \
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20910028 ↗MalfunctionDec 11, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE EXHIBITED CASSETTE SENSOR DEFECTIVE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20909522 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K081156. One submission often covers many models, so check the product and lot details in each record.
- Z-0011-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
- Z-0018-2025 · Jun 26, 2024 · Open, ClassifiedENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
- Z-0014-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
- Z-0017-2025 · Jun 26, 2024 · Open, ClassifiedENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
- Z-0012-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
- Z-0013-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
- Z-0015-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
- Z-0010-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
- Z-0016-2025 · Jun 26, 2024 · Open, ClassifiedCADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
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 · 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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