CADD 21-7308-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 526 adverse event reports that list this exact device (DI 10610586032370), received between Aug 21, 2018 and Sep 24, 2026 — classified as 1 death, 2 injuries, 523 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (118 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.

Recalls naming this device

1. 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 ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 526 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported that the CADD Cassette was leaking during use with patient. There was patient involvement but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883658 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847078 ↗
• MalfunctionSep 15, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779070 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740005 ↗
• MalfunctionJul 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A FILLED CASSETTE WAS SEALED, PLACED IN A LIGHT-PROTECTIVE BAG, AND STORED OVERNIGHT IN A TEMPERATURE-CONTROLLED REFRIGERATOR. UPON COLLECTION, LIQUID WAS FOUND ACCUMULATED IN THE BOTTOM OF THE BAG, INDICATING LEAKAGE FROM THE CASSETTE. THE CASSETTE HAD BEEN FILLED USING A BD SYRINGE, LUER-LOCK AND SEALED WITH THE SUPPLIED CAP, WITH NO OTHER MATERIALS CONTACTING THE CASSETTE DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696411 ↗
• MalfunctionJun 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A DEFECTIVE CADD CASSETTE WAS IDENTIFIED UPON BEING PREPARED FOR USE. THE EVENT OCCURRED DURING PATIENT USE. AN INVESTIGATION DETERMINED THAT THERE WAS A LEAK AT THE CORNER OF THE CASSETTE. THIS MALFUNCTION MAKES THE EVENT REPORTABLE. NO PATIENT HARM OR ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642871 ↗
• MalfunctionJun 16, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT AN INFUSION CASSETTE WAS OVER DELIVERING THE MEDICATION TO A PATIENT IN A SHORT PERIOD OF TIME. THE EVENT OCCURRED DURING INFUSION AND THERE WAS NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524109 ↗
• MalfunctionJun 11, 2026Obstruction of Flow

  AN EVENT INVOLVED A CADD RESERVOIR CASSETTE WHERE IT WAS REPORTED THAT TWO RESERVOIR CASSETTES TRIGGERED A DOWNSTREAM OCCLUSION ALARM, IMMEDIATELY UPON PUMP START-UP (CADD SOLIS IN CONTINUOUS MODE). THE REPORTER STATED THAT THE CLAMP WAS HANDLED CORRECTLY AND THE EXTENSION LINE WAS CORRECTLY ORIENTED. MULTIPLE ATTEMPTS TO REMOVE AND REINSTALL THE CASSETTE WERE UNSUCCESSFUL. THE CASSETTE (250 ML) AND THE PUMP WERE SUBSEQUENTLY REPLACED. THE PUMP IS NOT AT FAULT (THE CASSETTE SHOWS THE SAME DEFECT ON SEVERAL PUMPS, AND OTHER CASSETTES DO NOT TRIGGER ANY ALARM ON THE CURRENT PUMP). THE PUMP WAS PROGRAMMED IN CONTINUOUS MODE OVER 24 HOURS. THERE WAS PATIENT INVOLVEMENT, AND A DELAY IN THERAPY OF ONE HOUR BUT NO HARM REPORTED. THIS MAY STOP DELIVERY AND LEAD TO UNDER INFUSION WHICH MAY LEAD TO ANY HAZARDOUS SITUATION TO THE PATIENT WHILE INFUSION. THIS REPORT CAPTURES THE SECOND OF TWO RESERVOIRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469350 ↗
• MalfunctionMay 29, 2026Contamination

  IT WAS REPORTED THAT THE DEVICE EXHIBITED IMPURITIES WITHIN THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337574 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S PUMP WAS LEAKING INSIDE THE POUCH. PER REPORTER, THE PATIENT'S WIFE DISCOVERED A WHITE CASTING ON THE OUTSIDE OF THE POUCH AND WHEN THE PUMP WAS BROUGHT INTO THE CLINIC, THE CASSETTE WAS FOUND TO HAVE AN ACTIVE LEAK. REPORTER STATED IT WAS ESTIMATED A LOSS OF ABOUT 5 ML OCCURRED FROM THE BAG WITHIN THE CASSETTE AFTER DRAWING UP ALL THE MEDICATION THAT WAS LEFT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176907 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE BAG LEAKED BEFORE THE PATIENT LEFT THE CLINIC. PER REPORTER, THE CASSETTE COULD NOT BE OPENED TO INSPECT THE BAG, BUT THE MEDICATION LEAKED OUT OF THE SIDE OF THE CASSETTE WHILE BEING HELD AT AN ANGLE. THE UNIT WAS DISCARDED. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176901 ↗
• MalfunctionApr 20, 2026Device Sensing Problem; Pressure Problem

  IT WAS REPORTED THAT THE PRESSURE ALARM WAS TRIGGERED, WITH NO BLOCKAGE. THE EVENT OCCURRED DURING PATIENT USE, HOWEVER THERE WAS NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932388 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING OUT INTO THE INNER BAG. EVENT OCCURRED DURING POST COMPOUNDING, PRIOR TO USE BY CUSTOMER. THE LEAK WAS CONTAINED WITHIN SEALED OVER THE POUCH AND THERE WAS NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE PATIENT HAD TO BE DELAYED FOR TREATMENT TO THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867424 ↗
• MalfunctionApr 2, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE UNDER DELIVERED. THE DEVICE BEEPED AND DISPLAYED INFUSION COMPLETE, BUT THE MEDICATION WAS NOT DONE. THE INFUSION WAS RESTARTED BUT IT HAPPENED AGAIN. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772462 ↗
• MalfunctionMar 26, 2026Complete Blockage

  IT WAS REPORTED THAT THE 250ML CASSETTES HAD REPEATEDLY ALARMED WITH A DOWNWARD OCCLUSION WHILE THEY HAD BEEN COMPLETING THE PREPARATION PROCESS. THE PUMP HAD BEEN REMOVED AND THE TUBING HAD BEEN MASSAGED, WHICH HAD TYPICALLY RESOLVED THE ISSUE, ALTHOUGH IT HAD OCCASIONALLY REQUIRED MULTIPLE ATTEMPTS. THIS ISSUE HAD NOT BEEN OBSERVED WITH THE 100ML CASSETTES. THE TECHNICIANS HAD STATED THAT THIS HAD PREVIOUSLY OCCURRED ONLY OCCASIONALLY, BUT RECENTLY IT HAD BEEN HAPPENING ALMOST EVERY TIME. THE EVENT OCCURRED DURING SET UP AT THE CLINIC AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704430 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE WAS LEAKING, AND THE FACILITY HAD BELIEVED THAT THE BAG MIGHT HAVE BEEN PINCHED WHEN THE CASSETTE HAD BEEN CLOSED, WHICH MAY HAVE CAUSED THE LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701903 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663604 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN COMPOUNDING BLINATUMOMAB IN CASSETTE RESERVOIR, THE OUTER PLASTIC COVER WAS CLICKED INTO PLACE LIKE NORMAL, AND WHEN THE NURSES WENT TO HOOK IT UP TO THE PATIENT, THEY HAVE NOTICED THAT THE CADD (AMBULATORY INFUSION DEVICE CASSETTE) WAS SWIMMING IN DRUG, AND A SPLIT HAD OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM / ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649776 ↗
• MalfunctionMar 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE TWO BLINATUMOMAB DOSES PREPARED BY BAXTER THAT HAVE LEAKED AND ONE OF THEM HAD A PIN PRICK LEAK. THE EVENT OCCURRED AT HOSPITAL DURING COMPOUNDING BY BAXTER OFFSITE, NOTED BY PHARMACY POTENTIALLY WHEN CASSETTE ASSESSED. OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THE ISSUE WAS ESCALATED TO QUALITY TEAM OR MARKETING MANAGER. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582304 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE TWO BLINATUMOMAB DOSES PREPARED BY BAXTER THAT HAVE LEAKED AND ONE OF THEM HAD A PIN PRICK LEAK. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545256 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED WITH THE CADD MEDICATION CASSETTE. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533233 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT RE LEAKING CADD CASSETTE 250ML CASSETTES FILLED ON FRIDAY WITH BLINATUMOMAB NO LEAK NOTED BUT BUBBLES THAT NEEDED TO BE REMOVED. RAN FOR 20 HOURS PATIENT RETURNED ON SUNDAY NIGHT, AS NOTED FLUID LEAKING INTO PATIENT CASSETTE FORM THE INTERNAL BAG OF DRUG. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532847 ↗
• MalfunctionFeb 25, 2026Air/Gas in Device

  IT WAS REPORTED THAT THERE WERE TWO DEVICE'S WITH FAULTY TUBING IN THE PAST TWO DAYS. THAT MEANT THE TUBING MOVED BACKWARDS AND FORTH AND THEY COULD NOT REMOVE BUBBLES FROM THE INFUSION. TWO UNITS WERE AFFECTED.] CUSTOMER MENTIONED THAT THERE HAD MORE DIFFICULTY REMOVING THE BUBBLES OR AIR FROM THE CASSETTE. EVENT OCCURRED AT HOSPITAL DURING UPON OPENING. OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449776 ↗
• MalfunctionFeb 24, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PUMP HAD INDICATED THAT 114 ML HAD BEEN DELIVERED, BUT UPON RETURN, APPROXIMATELY 16 ML OF 5-FU HAD REMAINED IN THE CASSETTE. IT WAS CONSIDERED POSSIBLE THAT THE CASSETTE HAD BEEN OVERFILLED, ALTHOUGH 16 ML WAS MORE THAN EXPECTED. THE 5-FU HAD BEEN LOADED INTO A 250 ML CASSETTE. THE PATIENT HAD REPORTED THAT NO ALARMS HAD BEEN TRIGGERED DURING THE INFUSION. THE CONTINUOUS INFUSION HAD BEEN DELIVERED AT 2.5ML PER HOUR WITH A TOTAL RESERVOIR VOLUME OF 114 ML, OF WHICH 98ML HAD BEEN ADMINISTERED, WHILE THE AIR DETECTOR AND UPSTREAM SENSOR HAD REMAINED OFF THROUGHOUT THE 46-HOUR INFUSION, WITH THE PUMP SET AT LOCK LEVEL 2, THE PUMP HAVING BEEN USED TO PRIME THE EXTENSION TUBING, AND THE PATIENT NOT HAVING 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. ASSOCIATED PUMP AND TUBING COMPLAINT DOCUMENTED ON CN-454375 AND CN-454400.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434527 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  IT WAS REPORTED THAT THE TUBING HAD BEEN DISCONNECTED AT THE CONNECTION NEAREST THE PORT. THE PATIENT HAD DENIED THE PRESENCE OF BLOOD IN THE TUBING NEAR THE PORT. 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 24400040 ↗

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-0016-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
• Z-0013-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
• Z-0012-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
• Z-0015-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
• Z-0014-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
• Z-0010-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
• Z-0018-2025 · Jun 26, 2024 · Open, Classified
  ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
• Z-0017-2025 · Jun 26, 2024 · Open, Classified
  ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
• Z-0011-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24