CADD 21-7301-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 16, 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 ICU Medical CADD infusion set is tubing used with CADD medication pumps. Its 494 reports most often describe alarm faults and fluid leaks. Most patients had no clinical signs, and the reports include no injuries and no deaths. There are 4 open recalls, covering weak bag welds that can leak medication and tubing blockages that can cause underdelivery and false 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
- 467
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 467 adverse event reports that list this exact device (DI 10610586027215), received between Jun 8, 2018 and Sep 25, 2026 — classified as 467 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (157 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 16, 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-2525-2025 · 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-0013-2025 · 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
- Device Alarm System157
- Fluid/Blood Leak146
- Contamination34
- Leak/Splash24
- Insufficient Flow or Under Infusion22
- Connection Problem18
- Obstruction of Flow18
- Output Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions355
- No Consequences Or Impact To Patient39
- No Information25
- No Patient Involvement23
- Insufficient Information18
- No Known Impact Or Consequence To Patient6
- Low Blood Pressure/ Hypotension5
- Pallor4
Recent adverse event reports
The 25 most recent of 467 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fluid/Blood Leak; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903169 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the reservoir cassette has holes in the ends of the red caps, resulted in product leakage and loss of sterility. The issue was identified post compounding and charging of the units. There was no patient involvement. Therefore, no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888509 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888503 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that the reservoir cassette exhibited holes in the ends of the red caps, resulting in product leakage and a loss of sterility. The issue was identified after compounding and charging the units. There was no patient involvement; therefore, no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869501 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846811 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846657 ↗MalfunctionSep 17, 2026Particulates
It was reported that during production, visual inspection identified particulate matter within a 50 mL grey CADD cassette. The particles included one fiber-like particle that broke into pieces upon agitation and several small brownish oblong particles. There was no patient involvement, and no harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808205 ↗MalfunctionSep 17, 2026Particulates
It was reported that during production, visual inspection identified particulate matter within a 50 mL grey CADD cassette. The particles included one fiber-like particle that broke into pieces upon agitation and several small brownish oblong particles. There was no patient involvement, and no harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806657 ↗MalfunctionSep 17, 2026Particulates
During production involving the 50 mL gray CADD cassettes, a 100% visual inspection identified one cassette containing particulate matter. These cassettes were utilized by IntegraDose for the administration of the controlled substance, Fentanyl Citrate. Upon evaluation, staff reported that one particle appeared fiber-like and fragmented into smaller pieces when agitated, while the remaining particles were described as small, brownish, oblong-shaped particulates. No patients were exposed to the affected cassette, and no patient harm or adverse events were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805923 ↗MalfunctionSep 17, 2026Particulates
It was reported that during production of the 50 mL grey CADD cassettes, a particle was identified during 100% visual inspection. These cassettes were used by IntegraDose for the delivery of Fentanyl Citrate. Staff described the particles as follows: one particle was fiber-like and broke into pieces upon agitation, while the others were small, brownish, oblong particles. There was no patient involvement and no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803542 ↗MalfunctionSep 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747137 ↗MalfunctionSep 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747136 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740757 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740657 ↗MalfunctionSep 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673594 ↗MalfunctionJul 3, 2026Particulates
DURING PRODUCTION USING 50 ML GREY CADD CASSETTES, A PARTICLE WAS IDENTIFIED IN ONE CASSETTE DURING 100% VISUAL INSPECTION. THE PARTICLE WAS DESCRIBED AS GRAYISH, FLAT, APPROXIMATELY 2 MM IN SIZE, AND FLOATING WITHIN THE CASSETTE. NO PATIENT INVOLVEMENT OCCURRED, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25705219 ↗MalfunctionMay 15, 2026Particulates
IT WAS REPORTED THAT THAT A 50 ML MEDICINE CASSETTE WAS RETURNED FROM THE HOSPITAL PHARMACY'S DRUG MANUFACTURING UNIT AT THE OFFICE BECAUSE OF A SUSPECTED PRODUCT DEFECT. THE CASSETTE HAD BEEN FILLED BEFORE IT WAS NOTICED THAT A DARK HAIR WAS VISIBLE INSIDE THE CARTRIDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183459 ↗MalfunctionMay 13, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AFTER THE ADDITION OF HYDROMORPHONE AND SALINE IN A 50 ML CASSETTE, THE LEAK WAS DETECTED FROM THE CASSETTE BLADDER DURING PRIMING. THE REPORTED LEAKING WILL EXPOSE THE HEALTH CARE PROFESSIONAL TO THE DRUGS WHICH WILL CAUSE HARM. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161491 ↗MalfunctionApr 1, 2026Contamination
IT WAS REPORTED THAT THERE WERE PARTICLES IN THE 50 ML GREY CADD CASSETTES. THESE CASSETTES ARE USED BY INTEGRADOSE FOR DELIVERY OF THE CONTROLLED SUBSTANCE FENTANYL CITRATE. STAFF HAS IDENTIFIED THESE PARTICLES AS ¿2 CRESCENT-SHAPED SLIVERS, MOSTLY PLASTIC IN NATURE, AND ONE VERY SMALL ROUNDISH AND OPAQUE PARTICLE.¿ THESE PARTICLES ARE SIMILAR TO THOSE THEY HAVE BEEN SEEING AT INTEGRADOSE. THE EVENT OCCURRED DURING VISUAL INSPECTION SO THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756879 ↗MalfunctionMar 31, 2026Environmental Particulates
IT WAS REPORTED THAT THERE WERE PARTICLES IN THE 50 ML GREY CADD CASSETTES. THESE CASSETTES ARE USED BY INTEGRADOSE FOR DELIVERY OF THE CONTROLLED SUBSTANCE FENTANYL CITRATE. STAFF HAS IDENTIFIED THESE PARTICLES AS ¿2 CRESCENT-SHAPED SLIVERS, MOSTLY PLASTIC IN NATURE, AND ONE VERY SMALL ROUNDISH AND OPAQUE PARTICLE.¿ THE EVENT OCCURRED DURING VISUAL INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748372 ↗MalfunctionMar 31, 2026Environmental Particulates
IT WAS REPORTED THAT THERE WERE PARTICLES IN THE 50 ML GREY CADD CASSETTES. THESE CASSETTES ARE USED BY INTEGRADOSE FOR DELIVERY OF THE CONTROLLED SUBSTANCE FENTANYL CITRATE. STAFF HAS IDENTIFIED THESE PARTICLES AS ¿2 CRESCENT-SHAPED SLIVERS, MOSTLY PLASTIC IN NATURE, AND ONE VERY SMALL ROUNDISH AND OPAQUE PARTICLE.¿ THE EVENT OCCURRED DURING VISUAL INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24747883 ↗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 24607634 ↗MalfunctionMar 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE CASSETTE WAS FILLED BY THE HOSPITAL PHARMACIST AND NOTICED THAT THE CASSETTE WAS LEAKING. THE LOCATION OF THE LEAK COULDN'T BE IDENTIFIED. THE CASSETTE JUST LEAKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505866 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT WHEN FILLING UP THE CADD 50ML CASSETTE WITH FENTANYL, THE BAG INSIDE THE CASSETTE STARTS TO LEAK. THERE WAS NO PATIENT INJURY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260652 ↗MalfunctionFeb 3, 2026Contamination
IT WAS REPORTED THAT AFTER COMPOUNDING HYDROMORPHONE, THERE WAS A FOREIGN MATTER IN THE CASSETTE THAT RESEMBLED HAIR. THE EVENT OCCURRED IMMEDIATELY ON USE. SAMPLE IS NOT AVAILABLE FOR RETURN. THERE WAS UNKNOWN HARM AND UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245436 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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