CADD 21-7300-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This CADD cassette is an infusion set used with a CADD pump to deliver medication. Many of the 124 reports describe fluid or medication leaking, and some describe particles found inside the cassette. The reports include no deaths and 4 injuries. Reports fell to 17 in the last 12 months from 35 in the previous 12. There are 4 open recalls, over leaking bags and infusion sets that can under-deliver.
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
- 121
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10610586027192), received between Mar 1, 2019 and Sep 25, 2026 — classified as 4 injuries, 117 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (56 reports).
4 FDA recall records name this device's identifier, 4 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.
Reports received per month
Recalls naming this device
- Aug 6, 2025Class IIOpen, Classified
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Z-2524-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 26, 2024Class IIOpen, Classified
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Z-0012-2025 · Root cause: Process control · 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-0963-2023 · 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 Leak56
- Leak/Splash21
- Contamination17
- Contamination /Decontamination Problem8
- Insufficient Flow or Under Infusion8
- Connection Problem6
- Obstruction of Flow5
- Inaccurate Delivery4
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- No Patient Involvement20
- Insufficient Information8
- No Consequences Or Impact To Patient6
- Inadequate Pain Relief4
- No Information4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903375 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809146 ↗MalfunctionJul 2, 2026Contamination
IT WAS REPORTED THAT VISUAL INSPECTION OF 100 ML YELLOW CADD CASSETTES IDENTIFIED WITH A PARTICLE IN TWO CASSETTES. THESE PARTICLES ARE SMALL, WHITE OR OPAQUE, ROUNDISH. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698551 ↗MalfunctionJul 2, 2026Contamination
IT WAS REPORTED THAT VISUAL INSPECTION OF 100 ML YELLOW CADD CASSETTES IDENTIFIED WITH A PARTICLE IN TWO CASSETTES. THESE PARTICLES ARE SMALL, WHITE OR OPAQUE, ROUNDISH. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698212 ↗MalfunctionJun 2, 2026Particulates
IT WAS REPORTED THAT A PARTICLE WAS IDENTIFIED DURING VISUAL INSPECTION WITHIN A RESERVOIR CASSETTE. THE PARTICLE WAS DESCRIBED AS SMALL, WHITE, OPAQUE, AND ROUND IN APPEARANCE. THERE WERE NO PATIENT INVOLVEMENT AND NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361182 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAKING IN THE CASSETTE WHICH IMPACTS THE QUALITY OF THE PRODUCT AND THE LEAKING OBSERVED AT THE LUER LOCK CAP AND SUSPECTED FROM THE BLADDER SEAM. THE EVENT OCCURRED DURING RECEIPT PRIOR TO USE; THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016547 ↗MalfunctionApr 28, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAKING IN THE CASSETTE WHICH IMPACTS THE QUALITY OF THE PRODUCT AND THE LEAKING OBSERVED AT THE LUER LOCK CAP AND SUSPECTED FROM THE BLADDER SEAM. THE EVENT OCCURRED DURING RECEIPT PRIOR TO USE; THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016546 ↗MalfunctionApr 21, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PRODUCT HAS A SLICED TUBING. IT WAS ALSO ADDED THAT WHITE CLAMP ON THE TUBING LEADING TO THE RED CAP WAS DAMAGING THE LINE BY CUTTING THROUGH PLASTIC. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944540 ↗MalfunctionApr 21, 2026Obstruction of Flow
IT WAS REPORTED THAT THE PRODUCT HAS AN INDENTATION PREVENTING FLOW. IT WAS ALSO ADDED THAT THE PRESSURE FROM THE CLAMP CAUSED THE TUBING TO FOLD INWARD. THE CUSTOMER HAD ISSUES WITH PRODUCT MOVING THROUGH THE LINE DUE TO THE FOLDING. THEY STATED THAT SOMETIMES THE PUMP GAVE AN OCCLUSION ALARM. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943936 ↗MalfunctionApr 17, 2026Fluid/Blood Leak
IT WAS REPORTED THAT CADDS THAT WERE FOUND TO BE LEAKING AFTER TRANSIT. CUSTOMERS SUSPECT THE WELDING OF THE BAG IS THE ISSUE, SIMILAR TO THE FIELD NOTICE SENT IN AUGUST 2025. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915946 ↗MalfunctionDec 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PRODUCTION VISUAL INSPECTION IDENTIFIED ONE CASSETTE CONTAINING TWO PARTICLES. STAFF DESCRIBED THE PARTICLES AS A (CLEAR SLIVER SHAPE AND A VERY SMALL OPAQUE ROUNDISH PARTICLE). THERE WAS NO PATIENT INVOLVEMENT. POSSIBLE LOT NUMBERS 6126001,6116308,6092852.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693411 ↗MalfunctionNov 7, 2025Particulates; Particulates
IT WAS REPORTED THAT DURING PRODUCTION USING THE 100 ML YELLOW CADD CASSETTES (PN 21-7300-24), A 100% VISUAL INSPECTION IDENTIFIED TWO CASSETTES WITH PARTICLES. THE MAJORITY OF THE CASSETTES USED WERE FROM LOT #6092860; HOWEVER, SINCE UNITS FROM OTHER LOTS WERE ALSO USED, IT IS NOT POSSIBLE TO SPECIFY A SINGLE LOT. LOT #6092860 HAS ALREADY BEEN FILED UNDER A PREVIOUS COMPLAINT ((B)(4)), AND LOT #6116309 HAS ALSO BEEN FILED UNDER A PREVIOUS COMPLAINT ((B)(4)). THESE CASSETTES ARE USED BY INTEGRADOSE FOR THE DELIVERY OF THE CONTROLLED SUBSTANCES FENTANYL CITRATE AND ROPIVACAINE HCL; THEREFORE, WE ARE UNABLE TO RETURN THE PRODUCT. THE PARTICLE APPEARS SIMILAR TO THOSE PREVIOUSLY OBSERVED AT INTEGRADOSE. SAMPLE PHOTO AND VIDEO WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498219 ↗MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE 100 ML CADD CASSETTE INTERNAL BAG HAD BEEN LEAKING. INTERNAL BAG HAD NOT BEEN SEALED. THE EVENT OCCURRED DURING COMPOUNDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487381 ↗MalfunctionNov 5, 2025Contamination; Contamination
IT WAS REPORTED THAT DURING PRODUCTION A PARTICLE WAS FOUND IN ONE UNIT DURING 100% VISUAL INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478671 ↗MalfunctionOct 28, 2025Contamination; Contamination
IT WAS REPORTED THAT THE CASSETTE CONTAINED PARTICLES, DESCRIBED AS OPAQUE, SLIVER/CRESCENT SHAPED IN APPEARANCE AND MOST LIKELY PLASTIC IN NATURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407968 ↗MalfunctionOct 28, 2025Contamination; Contamination
IT WAS REPORTED THAT THE CASSETTE CONTAINED PARTICLES, DESCRIBED AS OPAQUE, SLIVER/CRESCENT SHAPED IN APPEARANCE AND MOST LIKELY PLASTIC IN NATURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407941 ↗MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TWO DEVICES WERE FOUND TO BE LEAKING FROM THE BAG INTO THE PLASTIC HOUSING OF THE CADD CASSETTES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085546 ↗MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TWO DEVICES WERE FOUND TO BE LEAKING FROM THE BAG INTO THE PLASTIC HOUSING OF THE CADD CASSETTES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085538 ↗MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CADD CASSETTE WAS LEAKING TO THE OVER POUCH. THIS WAS IDENTIFIED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057210 ↗MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE CADD EXHIBITED LEAKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22897942 ↗MalfunctionAug 1, 2025Contamination; Contamination
IT WAS REPORTED THAT DURING PRODUCTION USING THE 100 ML YELLOW CASSETTES, VISUAL INSPECTION IDENTIFIED TWO CASSETTES WITH A PARTICLE. THE MAJORITY OF CASSETTES USED WERE FROM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689821 ↗MalfunctionJul 28, 2025Contamination; Contamination
IT WAS REPORTED THAT A PARTICLE WAS IDENTIFIED INSIDE THE BAG OF THE CASSETTE AFTER THE CASSETTE WAS FILLED. REPORTER STATED THAT IT WAS NOT POSSIBLE TO SPECIFY A SINGLE LOT NUMBER OF THE PRODUCT. REPORTER DESCRIBED THE PARTICLES AS, ¿SMALL PLASTIC CURLS.¿ THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629161 ↗MalfunctionJul 28, 2025Contamination; Contamination
IT WAS REPORTED THAT A PARTICLE WAS IDENTIFIED INSIDE THE BAG OF THE CASSETTE AFTER THE CASSETTE WAS FILLED. REPORTER STATED THAT IT WAS NOT POSSIBLE TO SPECIFY A SINGLE LOT NUMBER OF THE PRODUCT. REPORTER DESCRIBED THE PARTICLES AS, "SMALL PLASTIC CURLS." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629150 ↗MalfunctionJul 23, 2025Contamination; Contamination
IT WAS REPORTED THAT THERE WERE HAIR/FIBER LIKE MATERIAL IN 2 CADD CASSETTES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579741 ↗MalfunctionJul 23, 2025Contamination; Contamination
IT WAS REPORTED THAT THERE WERE HAIR/FIBER LIKE MATERIAL IN 2 CADD CASSETTES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579739 ↗
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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page