CADD 21-7002-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 10610586022128), received between Mar 2, 2017 and Sep 25, 2026 — classified as 1 injury, 330 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (101 reports).

1 FDA recall record name this device's identifier, 1 still open.

12 other recalls cover devices cleared under the same FDA submission (K843772); 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.

Recalls naming this device

1. Aug 6, 2025Open, 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-2523-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 331 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902969 ↗
• MalfunctionJun 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY 20 PERCENT OF THE CASSETTES EXHIBITED LEAKAGE OF THE FILLED PREPARATION FROM THE TUBING OUTLET AFTER FILLING. THE CLAMP INTENDED TO ENSURE A TIGHT SEAL WAS PLACED CORRECTLY AND IN THE USUAL MANNER ON THE TUBING. THE LEAKAGE HAS BEEN OBSERVED IN PRODUCTION BATCHES FROM WINTER 2025 THROUGH THE PRESENT. THE ISSUE OCCURS DURING PRODUCTION, RELATIVELY SOON AFTER THE CASSETTE HAS BEEN FILLED WITH THE PREPARATION AND THE CLAMP HAS BEEN APPLIED TO THE TUBING, FOLLOWED BY DISCONNECTION OF THE COUPLING BY THE OPERATOR. LEAKAGE MAY BEGIN IMMEDIATELY OR AFTER A FEW SECONDS. THE LEAKAGE RATE HAS BEEN OBSERVED TO RANGE FROM 7 TO 19 PERCENT, CORRESPONDING TO APPROXIMATELY 20 TO 50 UNITS PER BATCH; HOWEVER, IN SOME PRODUCTION BATCHES, THE NUMBER OF CASSETTES LEAKING FROM THE TUBING HAS BEEN LOWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25656200 ↗
• MalfunctionJun 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT 20% OF CASSETTES LEAKED FROM THE TUBING OUTLET AFTER FILLING, DESPITE THE CLAMP BEING APPLIED CORRECTLY. THE ISSUE HAS BEEN OBSERVED SINCE WINTER 2025 AND OCCURS SHORTLY AFTER FILLING, WHEN THE COUPLING IS DISCONNECTED. LEAKAGE MAY BEGIN IMMEDIATELY OR WITHIN A FEW SECONDS. AN EXTENSIVE INVESTIGATION CONFIRMED NO CHANGES TO THE FILLING PROCESS PARAMETERS. THE EVENT OCCURRED DURING ONE FILLING OPERATION. THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, IF THE MALFUNCTION REOCCURS IT WILL EXPOSE THE DRUG TO PATIENT/HEALTH CARE PROFESSIONAL WHICH MAY POTENTIALLY IMPACT HEALTH OF THE PATIENT/HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634834 ↗
• MalfunctionJun 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PORTION OF THE CASSETTES EXHIBITED LEAKAGE FROM THE TUBING OUTLET AFTER FILLING, DESPITE THE CLAMP BEING APPLIED CORRECTLY. THE LEAKAGE OCCURRED SHORTLY AFTER FILLING AND DISCONNECTION OF THE COUPLING. THE ISSUE HAS BEEN CONSISTENTLY OBSERVED IN PRODUCTIONS FROM WINTER 2025 TO PRESENT. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25628633 ↗
• MalfunctionMay 5, 2026Contamination

  IT WAS REPORTED THAT THE NURSE NOTICED SOME BLACK MATERIAL HAD STUCK TO THE BAG INSIDE DURING FILLING THE CASSETTE. THE CASSETTE WAS NOT USED WITH PATIENT TO AVOID IT GETTING INTO THE PATIENT'S BLOODSTREAM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085856 ↗
• MalfunctionMar 13, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP HAD ALARMED, BUT THE SPECIFIC MESSAGE DISPLAYED ON THE SCREEN HAD NOT BEEN REMEMBERED BY THE NURSE. THE CONTINUOUS INFUSION RATE HAD BEEN 2.2 ML PER HOUR, WITH A STARTING RESERVOIR VOLUME OF 102 ML AND A REMAINING RESERVOIR VOLUME OF 0 ML. THE AIR DETECTOR AND THE UPSTREAM SENSOR HAD BEEN TURNED OFF. THE LENGTH OF INFUSION HAD BEEN 39 HOURS AND 37 MINUTES, ALTHOUGH IT HAD BEEN INTENDED TO RUN FOR 46 HOURS. THE LOCK LEVEL HAD BEEN LL2. THE PATIENT HAD NOT BEEN MEDICALLY AFFECTED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593947 ↗
• MalfunctionMar 13, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE BAG HAD APPEARED EMPTY, WHILE THE DEVICE HAD INDICATED THAT 8 ML REMAINED. THERE WAS NO INJURY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593273 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS LEAKING FROM THE CONNECTOR AND THERE WAS WHITE POWER ON THE PUMP AND BAG. THEY WERE INSTRUCTED TO PUT THE PUMP IN A CHEMO SPILL BAG. THE PUMP WAS POWERED OFF, CLAMP TUBING, AND THEY WERE EDUCATED ON CHEMO SPILL PROTOCOL. THE MEDICATION USED WAS 5FU. THE LEAK FOR THIS TIME AND THE PREVIOUS LEAK OCCURRED AT THE SAME PLACE WHERE THE EXTENSION SET AND SWIVEL PIECE WERE CONNECTED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521158 ↗
• MalfunctionFeb 10, 2026Contamination

  THE CUSTOMER REPORTED THAT THEY HAD 100ML CASSETTE EACH DAY REJECTED DUE TO PARTICULATE MATTER. BOTH CONTAINS 5 FU. PER REPORTER, THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE WAS CONFIRMED THE LOOSE PARTICULATES FOUND WITHIN THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304533 ↗
• MalfunctionFeb 10, 2026Contamination

  THE CUSTOMER REPORTED THAT THEY HAD 100ML CASSETTE EACH DAY REJECTED DUE TO PARTICULATE MATTER. BOTH CONTAINS 5 FU. PER REPORTER, THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE WAS CONFIRMED THE LOOSE PARTICULATES FOUND WITHIN THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304517 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THEY NOTICED WHITE POWDER RESIDUE ON THE BAG AND THEN REALIZED THE TUBING HAD DISCONNECTED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, AND THERE WAS NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278365 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD LEAKED. THERE WAS WHITE RESIDUE ALL OVER THE BAG. THERE WAS NO PUMP ALARM NOTED BY THE PATIENT. UPON INVESTIGATION, IT WAS NOTED THAT THE LEAK HAD COME FROM THE CONNECTION WHERE THE PUMP CASSETTE MEETS THE EXTENSION TUBING. THERE WERE NO INJURY AND THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961113 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP HAD WHITE STUFF ALL OVER IT ALONG WITH THE CARRYING CASE. THEY INSTRUCTED TO STOP THE PUMP, POWER OFF, AND THE CLAMP TUBING. THE CHEMO SPILL INSTRUCTIONS WERE PROVIDED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959650 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CASSETTE WAS LEAKING. SINCE THE CLAMP WAS CLOSED CLOSE TO THE CARTRIDGE AFTER FILLING, ONE MUST PROBABLY ASSUME A LEAK AT THE BAG SEAM OR AT THE TRANSITION BETWEEN THE BAG AND THE TUBE. THE CASSETTE DID NOT SHOW ANY ABNORMALITIES IN THE FINAL INSPECTION, SHORTLY AFTER FILLING. THE LEAK ONLY BECAME APPARENT AFTER A FEW DAYS, DURING WHICH THE CASSETTE WAS STILL IN STORAGE. THERE WAS NO PATIENT INVOLVEMENT, AS NO APPLICATION TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850297 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING FILLING THE SOLUTION CONTAINING THE MEDICINE 5 FLUOROURACIL LEAKS OUT ALONG THE EDGES OF THE BAG INSIDE THE CASSETTE. THE OPERATOR OF THE DEVICE WAS A LAB-TECHNICIAN THE EVENT OCCURRED ON VERTICAL LAMINAR FLOW UNDER HOOD. THERE WAS NO PATIENT INVOLVEMENT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523471 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING WAS DISCONNECTED FROM THE CASSETTE TUBING AND THE MEDICATION THAT WAS INFUSED INTO THE CARRIER POUCH SPILL INTO THE PUMP. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513877 ↗
• MalfunctionNov 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT ARRIVED WITH A LEAKING PUMP. THEY NOTICED IT AROUND 10 AM AND THE BAG HAD FLUID IN IT. IT WAS DRY BUT THE WHITE RESIDUE WAS PRESENT ON THE PUMP AND BAG. THEY THINK THAT THE LEAKING OCCURRED SOMEWHERE BETWEEN 9PM - 10AM AND THEY BELIEVE IT WAS FROM THE CASSETTE TUBING TO TUBING SET CONNECTOR. SPIROS WERE ADDED ON THE DEVICE BETWEEN THE PORT AND THE ADMINISTRATION/EXTENSION SET. NO PATIENT HARM OR NO PATIENT INJURY WAS REPORTED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. ASSOCIATED TUBING AND PUMP COMPLAINTS DOCUMENTED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490963 ↗
• MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHEMOTHERAPY FLUID HAD SPILLED INSIDE THE PATIENT¿S CARRIER POUCH AND HAD LEAKED ONTO THE PUMP. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357499 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD NOTICED A WHITE RESIDUE ON HER CARRYING CASE AND, UPON REMOVING THE PUMP, HAD OBSERVED THAT IT WAS WET. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294459 ↗
• MalfunctionSep 16, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED AT THE CONNECTION CLOSEST TO THE PUMP. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066746 ↗
• MalfunctionSep 16, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A DISCONNECTION BELOW THE PORT. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066735 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CASSETTE EXHIBITED A LEAKAGE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946508 ↗
• MalfunctionSep 2, 2025Contamination; Contamination

  THE CUSTOMER RETURNED THE PRODUCT FOR "FLOATERS", AND DURING PHYSICAL INSPECTION IT WAS FOUND THAT A PARTICULATE MATTER WAS OBSERVED IN THE FLUID PATH, WITHIN THE CASSETTE BAG. AFTER INVESTIGATION THE RESULTS INDICATED A REPORTABLE MALFUNCTION DUE TO THE PARTICULATE MATTER OBSERVED IN THE FLUID PATH, WITHIN THE CASSETTE BAG. THE EVENT OCCURRED DURING SET UP AT CLINIC, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938119 ↗
• MalfunctionSep 2, 2025Contamination; Contamination

  THE CUSTOMER RETURNED THE PRODUCT FOR "FLOATERS", AND DURING PHYSICAL INSPECTION IT WAS FOUND THAT A PARTICULATE MATTER WAS OBSERVED IN THE FLUID PATH, WITHIN THE CASSETTE BAG. AFTER INVESTIGATION THE RESULTS INDICATED A REPORTABLE MALFUNCTION DUE TO THE PARTICULATE MATTER OBSERVED IN THE FLUID PATH, WITHIN THE CASSETTE BAG. THE EVENT OCCURRED DURING SET UP AT CLINIC, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938032 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHEMO WAS LEAKING FROM TUBING INSIDE OF THE POUCH. PATIENT NOTES DRIED WHITE RESIDUE ON TUBING AND BAG. THEY HAD ALREADY POWERED THE PUMP OFF AND WAS ADVISED TO CLOSE THE CLAMPS. THE CHEMO SPILL PRECAUTIONS WERE DISCUSSED. THE PATIENT WAS CONNECTED TO A 5FU. THERE WAS NO REPORTED PATIENT HARM. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890867 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K843772. One submission often covers many models, so check the product and lot details in each record.

• Z-0062-2018 · Sep 25, 2017 · Terminated
  CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CA
• Z-0060-2018 · Sep 25, 2017 · Terminated
  CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(
• Z-0061-2018 · Sep 25, 2017 · Terminated
  CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-T
• Z-3071-2017 · Jun 5, 2017 · Terminated
  CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
• Z-1286-2015 · Feb 2, 2015 · Terminated
  CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
• Z-0987-2009 · Dec 9, 2008 · Terminated
  CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for u
• Z-0876-2008 · Dec 14, 2007 · Terminated
  Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
• Z-0877-2008 · Dec 14, 2007 · Terminated
  Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
• Z-0878-2008 · Dec 14, 2007 · Terminated
  Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 551
• Z-1215-2007 · Jun 18, 2007 · Terminated
  Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD
• Z-1214-2007 · Jun 18, 2007 · Terminated
  Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC 4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, In
• Z-1213-2007 · Jun 18, 2007 · Terminated
  Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical