CADD 21-7322-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 10610586029646), received between Feb 17, 2017 and Sep 22, 2026 — classified as 45 injuries, 346 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (155 reports).

2 FDA recall records name this device's identifier, 2 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.

Recalls naming this device

1. Dec 9, 2022Open, 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 ↗

2. Dec 9, 2022Open, 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

Recent adverse event reports

The 25 most recent of 391 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Leak/Splash

  It was reported that leakage was observed in the cassette tubing at the connection points. The issue was noted for the first time. Patient involvement and patient harm could not be confirmed and remain unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854179 ↗
• MalfunctionJun 26, 2026Excess Flow or Over-Infusion

  IT WAS CONFIRMED DURING VOLUMETRIC ACCURACY TEST OF A RETURNED ADMIN SET THAT IT DID NOT PERFORM WITHIN THE DELIVERY ACCURACY RATE UNDER NOMINAL CONDITIONS AND OVER INFUSION WAS OBSERVED. THEREFORE, IF THIS OVER INFUSION REOCCURS DURING INFUSION IT WILL POTENTIALLY IMPACT THE PATIENT HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642536 ↗
• MalfunctionMay 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET EXHIBITED LEAKAGE, WITH THE CASSETTE PARTIALLY UNLATCHED AND AN ACTIVE ALARM CONDITION THAT PREVENTED THE PUMP FROM BEING TURNED OFF. THE MEDICATION BEING ADMINISTERED WAS BLINCYTO. THE EVENT OCCURRED DURING PATIENT USE; HOWEVER, NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301067 ↗
• MalfunctionMay 8, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE UNDER-DELIVERED. THE PATIENT RETURNED FOR PUMP UNHOOK, AND THE 5FU BAG WAS STILL APPROXIMATELY HALF FULL. THE PUMP ACTIVITY LOG WAS CHECKED, AND IT DOESN'T SHOW ANYTHING OTHER THAN THE CLINICIAN OR PHYSICIAN PROGRAMMING THE PUMP AND THAT THE PATIENT TURNED THE PUMP OFF THAT MORNING. PHARMACY STAFF AND CLINICIAN OR PHYSICIAN REVIEWED THE BAG AND ABOUT 70ML OF MEDICATION REMAINED. THE MEDICATION BEING INFUSED WAS 5-FU(5-FLUOROURACIL) WITH PROGRAMMED RATE AT 3ML PER HOUR. THE DEVICE DISPLAYED A REMAINING VOLUME OF 0ML, WHILE APPROXIMATELY 70ML WAS LEFT IN THE BAG, AND VOLUME GIVEN AS PER THE DEVICE WAS 138ML. THE EVENT OCCURRED DURING INFUSION, NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126926 ↗
• MalfunctionMar 26, 2026Insufficient Flow or Under Infusion

  AN EMAIL WAS RECEIVED REGARDING A CADD ADMINISTRATION SET WITH ITEM 21-7322-24 AND LOT 6140818. IT WAS REPORTED THAT THE PUMP HAD ALARMED ¿COMPLETED.¿ THE REMAINING RESERVOIR VOLUME HAD BEEN 60 ML, AND THE LENGTH OF INFUSION HAD BEEN 46 HOURS. THE AIR DETECTOR HAD BEEN OFF, THE UPSTREAM SENSOR HAD BEEN OFF, AND THE LOCK LEVEL HAD BEEN SET TO 2. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING; THE TUBING HAD BEEN PRIMED MANUALLY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701670 ↗
• MalfunctionMar 26, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP HAD ALARMED COMPLETED. A PATIENT HAD COME IN FOR A DISCONNECT, AND THE INFUSION BAG HAD STILL CONTAINED APPROXIMATELY 60 ML, ALTHOUGH THE PUMP HAD INDICATED THAT THE FULL AMOUNT HAD BEEN DELIVERED. THE REMAINING RESERVOIR VOLUME HAD BEEN 0 ML DESPITE 60 ML REMAINING IN THE BAG. THE AIR DETECTOR HAD BEEN OFF, AND THE UPSTREAM SENSOR HAD BEEN OFF. THE LENGTH OF INFUSION HAD BEEN 46 HOURS. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING; THE TUBING HAD BEEN PRIMED MANUALLY. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701593 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET TUBING BROKE OFF FROM THE CONNECTOR. THE DEVICE WAS PROGRAMMED TO DELIVER A CONTINUOUS INFUSION RATE OF 0.6 ML PER HOUR, WITH A TOTAL RESERVOIR VOLUME OF 84 ML AND A REMAINING VOLUME OF 42.8 ML. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617923 ↗
• MalfunctionFeb 10, 2026Failure to Infuse

  IT WAS REPORTED THAT THERE WAS AN UNDER THE INFUSION. THE STARTING VOLUME HAD BEEN LISTED AS 101 ML, WITH A CONTINUOUS INFUSION RATE THAT HAD BEEN SET TO 0.6 ML PER HR. THE PUMP HAD INDICATED THAT 99.85 ML HAD BEEN DELIVERED, ALTHOUGH NO VISIBLE INFUSION HAD APPEARED TO OCCUR. THE MEDICATION REMAINING IN THE CASSETTE HAD NOT MATCHED THE RESERVOIR VOLUME DISPLAYED ON THE PUMP. THE REMAINING MEDICATION HAD BEEN WITHDRAWN TO CONFIRM THE DISCREPANCY, AND THE AMOUNT REMAINING HAD BEEN MEASURED AT APPROXIMATELY 100 ML. THE AIR DETECTOR AND THE UPSTREAM SENSOR HAD BEEN TURNED OFF, AND THE LENGTH OF INFUSION HAD BEEN RECORDED AS 7 DAYS. THE PUMP HAD NOT BEEN USED TO PRIME THE EXTENSION TUBING. INSTEAD, THE TUBING HAD BEEN PRIMED MANUALLY OR WITH THE DESIGNATED IV ROOM PRIMING PUMP. THE PATIENT HAD BEEN MEDICALLY AFFECTED, AS IT HAD BEEN DETERMINED THAT THE PATIENT DID NOT RECEIVE A FULL WEEK OF CHEMOTHERAPY. 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 24308895 ↗
• MalfunctionNov 13, 2025Improper Flow or Infusion; Infusion or Flow Problem; Improper Flow or Infusion; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PUMP HAD NOT ALARMED, AS CONFIRMED BY THE PATIENT. THE SCREEN HAD DISPLAYED "COMPLETED." THE CONTINUOUS INFUSION RATE HAD BEEN SET AT 3.3 ML/HR, WITH A STARTING AND REMAINING RESERVOIR VOLUME OF 150 ML. BOTH THE AIR DETECTOR AND UPSTREAM SENSOR HAD BEEN TURNED OFF. THE INFUSION HAD BEEN SCHEDULED FOR 46 HOURS, WITH A LOCK LEVEL OF 2. THE EXTENSION TUBING HAD NOT BEEN PRIMED USING THE PUMP; INSTEAD, IT HAD BEEN PRE-PRIMED WITH NORMAL SALINE BY ATTACHING THE BAG TO SALINE, NOT CHEMOTHERAPY. THE PATIENT HAD BEEN MEDICALLY UNAFFECTED, BUT THE TREATMENT HAD BEEN DELAYED. 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 23547581 ↗
• MalfunctionOct 22, 2025Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A LEAK HAD BEEN REPORTED AND HAD FOUND THAT THE LINE AT THE CONNECTION FROM THE PUMP TO THE TUBING HAD BECOME DISCONNECTED. IT WAS REPORTED THAT APPROXIMATELY TWO HOURS OF INFUSION REMAINED. IT HAD ALSO BEEN REPORTED THAT THE TUBING WAS COMPLETELY DISCONNECTED NEAR THE CADD PUMP CONNECTION, NOT NEAR THE PORTACATH CONNECTION. THE PATIENT HAD NOTICED A WHITE RESIDUE ON THE FANNY PACK UPON REALIZING THE LEAK. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360615 ↗
• MalfunctionOct 22, 2025Failure to Infuse; Failure to Infuse

  IT WAS STATED THAT THE DEVICE HAD AN OCCLUSION ISSUE. THERE WAS UNKNOWN PATIENT/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359723 ↗
• MalfunctionOct 21, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE FAULT THAT OCCURS WAS "OCCLUSION". USER HAD TRIED THE FAULTY SET/LINES ON ANOTHER PUMP, BUT THE SAME FAULT OCCURRED. THEY HAD LOOKED AT THE POSSIBLE FAULT WITH THE SET/LINE AND DETERMINED IT WAS LIKELY A PART IN THE CASSETTE HAD BEEN PLACED TOO TIGHTLY ON THE LINE CAUSING THE FAULT. THE EVENT OCCURRED DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351959 ↗
• MalfunctionSep 18, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE DEVICE EXHIBITED AN AIR IN LINE ALARM. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083490 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CADD UNIT FROM THE LOT WAS LEAKING. SAMPLE PHOTOS WERE PROVIDED AND ATTACHED TO THE FILE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039025 ↗
• MalfunctionSep 8, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS A KINK IN THE CIRCUIT, AND THE DRUG HAD NOT BEEN ADMINISTERED. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994256 ↗
• MalfunctionAug 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP HAD INDICATED THERE WAS 0 ML REMAINING, DESPITE THE BAG BEING FULL. PER REPORTER, THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME. REPORTER STATED THAT INFUSION HAD BEEN STARTED WITH 115 ML AT A CONTINUOUS RATE OF 2.5 ML/HR FOR 46 HOURS, WITH THE PUMP WAS DISPLAYING 0 ML REMAINING DESPITE VISIBLE VOLUME STILL PRESENT IN THE BAG. REPORTER STATED THE REMAINING AMOUNT COULD NOT BE MEASURED AS THE PRODUCT WAS CONSIDERED CONTAMINATED ONCE IT LEFT THE CLEAN ROOM. REPORTER STATED THE PUMP AIR DETECTOR HAD BEEN OFF, THE UPSTREAM SENSOR HAD BEEN ON, THE TUBING HAD BEEN PRIMED BY GRAVITY USING A NEEDLE, AND THE PATIENT HAD BEEN MEDICALLY AFFECTED BY NOT RECEIVING THE FULL DOSE OF FLUOROURACIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793417 ↗
• MalfunctionJul 23, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PUMP ALARMED NO DISPOSABLE. PER REPORTER, A CONTINUOUS INFUSION RATE OF 23 ML/HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 520 ML. THE AIR DETECTOR HAD BEEN TURNED ON AND THE UPSTREAM SENSOR HAD BEEN TURNED OFF. THE LENGTH OF INFUSION WAS 23 HOURS AND 30 MINUTES. REPORTER STATED THE TUBING WAS PRIMED MANUALLY. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575403 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CADD UNIT FROM THE LOT WAS LEAKING. SAMPLE PHOTOS WERE PROVIDED AND ATTACHED TO THE FILE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565693 ↗
• MalfunctionJul 21, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE MEDICINE DOESN'T PASS THROUGH. PER REPORTER, THE EVENT OCCURRED BEFORE PATIENT USE/DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559910 ↗
• MalfunctionJul 18, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT HAD PRESENTED WITH A SIGNIFICANT AMOUNT OF AIR AND BUBBLES IN THE INFUSION TUBING, AND THE PUMP HAD FAILED TO ALARM. THE CONTINUOUS INFUSION RATE HAD BEEN SET AT 0.6 ML/HR. THE TOTAL RESERVOIR VOLUME HAD BEEN CALCULATED AS FOLLOWS: ORDERED DOSE OF 11.55 MCG/DAY, ADMINISTERED DOSE OF 80.875 MCG, TOTAL VOLUME 102.7778 ML (WITH THE PUMP PROGRAMMED AT 103 ML), AND A VOLUME WITH OVERFILL OF 109.972 ML. AT THE TIME OF INCIDENT, 13.5 ML HAD BEEN ADMINISTERED. THE AIR DETECTOR HAD BEEN TURNED OFF, WHILE THE UPSTREAM SENSOR HAD BEEN ON. THE INFUSION DURATION HAD BEEN PROGRAMMED FOR 168 HOURS. AT 12:51, THE PATIENT HAD CLAMPED THE LINE AT HOME, AND BY 14:20, HAD BEEN CONNECTED TO A NEW PUMP. 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 22541822 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE TUBING COMPLETELY BROKE BETWEEN PUMP AND IV BAG DURING BLINCYTO INFUSION. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472364 ↗
• MalfunctionJul 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE UNDER DELIVERED. PER REPORTER THE DEVICE ALARMED "INFUSION COMPLETE OR EMPTY", HOWEVER, THE PATIENT DID NOT RECEIVE THE ENTIRE MEDICATION/BAG. THE PUMP INDICATED THAT INFUSION WAS COMPLETE BUT THERE WAS DEFINITELY AT LEAST 100 ML LEFT IN BAG. A CONTINUOUS INFUSION RATE OF 6 ML/HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 275 ML AND GIVEN 275 ML BUT THERE WAS STILL AT LEAST 100 ML IN THE BAG. THE AIR DETECTOR AND UPSTREAM SENSOR HAD BEEN TURNED OFF. THE LENGTH OF INFUSION HAD BEEN SET TO 46 HOURS, AND THE LOCK LEVEL HAD BEEN SET TO LL2. A CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) WAS USED TO FILL CASSETTE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413258 ↗
• MalfunctionJun 26, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THEY WERE GETTING A NO CASSETTE ATTACHED WITH SOLIS PUMPS BUT WERE WORKING WITH LEGACY PUMPS. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336633 ↗
• MalfunctionJun 25, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD ALARMED NO DISPOSABLE, PUMP WON'T RUN. THE PATIENT HAD NOT BEEN 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 22332871 ↗
• MalfunctionJun 23, 2025Disconnection; Increase in Pressure; Disconnection; Increase in Pressure

  IT WAS REPORTED THAT THE PUMP WAS ALARMING HIGH PRESSURE AND SCREEN READS STOPPED. THEY INSTRUCTED THE PATIENT TO MAKE SURE ALL THE CLAMPS WERE OPEN AND SLIDING FREELY UP AND DOWN ON THE TUBING, BUT THE PATIENT DID NOT KNOW WHAT A CLAMP WAS. WHILE THEY WERE CHECKING THE CLAMPS, THE PATIENT NOTICED THE TUBING WAS DISCONNECTED. THE SETTINGS WERE OBTAINED, AND PUMP HAD BEEN POWERED DOWN. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310160 ↗

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, Classified
  Smiths 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 · Terminated
  CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
• Z-1831-2016 · Apr 22, 2016 · Terminated
  CADD 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 · Terminated
  CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
• Z-0879-2008 · Dec 14, 2007 · Terminated
  Smiths 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