CADD 21-7394-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 586 adverse event reports that list this exact device (DI 10610586027536), received between Mar 14, 2017 and Sep 28, 2026 — classified as 2 deaths, 6 injuries, 578 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (343 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 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-0963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 586 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923041 ↗
• MalfunctionJun 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT DURING PRIMING, THE CADD ADMINISTRATION SET WOULD NOT FLUSH OR RUN AND CONSISTENTLY GENERATED DOWNSTREAM OCCLUSION ALARMS ON MULTIPLE PUMPS. THIS ISSUE MAY HAVE LED TO AN OCCLUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599823 ↗
• MalfunctionJun 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAKAGE OCCURRED AT THE FILTER ON THE INFUSION TUBING WHEN IT WAS IN USE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521998 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A CADD ADMINISTRATION SET, AND IT WAS REPORTED THAT A SMALL AMOUNT OF CHEMOTHERAPY SOLUTION WAS OBSERVED LEAKING FROM THE BACK OF THE FILTER. THERE WAS PATIENT INVOLVEMENT, AND NO HARM. THE EVENT OCCURRED ON THREE DATES, AND THIS REPORT CAPTURES THE SECOND OF THE THREE INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359907 ↗
• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THEY RECEIVED A CALL FROM A PATIENT¿S HOME HEALTH NURSE REPORTING LEAKAGE FROM THE PATIENT¿S IV UNASYN INFUSION. THE PATIENT WAS INSTRUCTED TO DISCONTINUE USE OF THE AFFECTED MEDICATION, SWITCH TO A NEW ONE, AND RETURN THE ORIGINAL MEDICATION TO OUR FACILITY FOR EVALUATION. AS A RESULT, THE REMAINING MEDICATION HAD TO BE DISCARDED. UPON RECEIVING THE RETURNED BAG, OUR TEAM CONDUCTED AN INITIAL INSPECTION. AT THAT TIME, NO VISIBLE LEAKS WERE IDENTIFIED FROM THE BAG AND CADD ADMIN SET ITSELF. WE ALSO EXAMINED THE ENCLOSURE AND CONNECTION POINT BETWEEN THE CADD ADMINISTRATION SET AND THE BAG AND FOUND NO APPARENT ISSUES AT THOSE JUNCTIONS. HOWEVER, THE PATIENT REPORTED A SENSATION OF DAMPNESS AROUND THE FILTER AREA. TO FURTHER INVESTIGATE, THEY HUNG THE BAG OF FLUID AND LEFT THE TUBING IN A BUCKET OVERNIGHT WITH THE LINE CLAMPED AND PLUGGED. WHEN WE RETURNED IN THE MORNING, THERE WAS FLUID IN THE BUCKET LEADING US TO BELIEVE THE LINE DEFINITELY LEAKED FROM SOMEWHERE. THIS HAS BEEN REPORTED A FEW TIMES BY DIFFERENT PATIENTS. SAMPLE PHOTOS PROVIDED BY CUSTOMER HAVE BEEN ATTACHED TO THIS RECORD. THE PATIENT REPORTED THE LEAKAGE DURING HIS INFUSION. HE MENTIONED FEELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245960 ↗
• MalfunctionMay 20, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE EPIDURAL TUBING WAS NOT INFUSING THE MEDICATION. THE ORIGINALLY INTENDED PROCEDURE WAS EPIDURAL MEDICATION INFUSION. THE EVENT OCCURRED IN A HOSPITAL SKILLED NURSING UNIT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230127 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A SMALL DROP OF CHEMOTHERAPY SOLUTION LEAKED FROM THE BACKSIDE OF THE FILTER. A FEW ORANGE/RED DOTS NOTED TO SLEEVE OF HIS CENTRAL LINE. UPON FURTHER INSPECTION, THE NURSE NOTED THAT THERE WAS A TINY AMOUNT OF FLUID LEAKING FROM THE BACK SIDE OF CIRCULAR FILTER. LEAK DID NOT REACH PATIENT AS HE HAD A TRANSPARENT DRESSING BETWEEN THE FILTER AND HIS SKIN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940172 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE FACILITY ATTEMPTED TO USE THE PRODUCT, IT LEAKED LIQUID EXCESSIVELY, RENDERING IT UNUSABLE. THIS IS THE SECOND OCCURRENCE INVOLVING THE SAME LOT NUMBER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457138 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT CONSISTENTLY LEAKS EACH TIME THE PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444600 ↗
• MalfunctionFeb 18, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PUMP ALARMED AND THEY HEARD TWO BEEPS. A MESSAGE OF UPSTREAM OCCLUSION WAS DISPLAYED ON THE SCREEN. CLEAR OCCLUSION BETWEEN PUMP AND RESERVOIR. THE PUMP WAS MALFUNCTIONED WHEN THE PATIENT LEFT THE FACILITY. THE SCREEN SHOWED A MESSAGE SAYING THERE WAS AN OCCLUSION, BUT NO OCCLUSION WAS FOUND. UPON INSPECTION OF THE BAG AND LINE, THE PUMP NEVER ALARMED TO MAKE THE PATIENT AWARE OF THE ISSUE. THIS CAUSED THEM TO NOT RECEIVE THEIR DOSE. A CONTINUOUS INFUSION RATE OF 41.7 ML PER HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 1112.77 ML AND A GIVEN VOLUME OF 0.2 ML. THE AIR DETECTOR HAD BEEN TURNED OFF. THE UPSTREAM SENSOR HAD BEEN TURNED OFF. THE LENGTH OF INFUSION HAD BEEN SET TO 24 HOURS. THE LOCK LEVEL HAD BEEN SET TO UNLOCKED. A CSTD WAS USED TO FILL THE CASSETTE. THE PUMP WAS NOT USED TO PRIME THE EXTENSION TUBING. THE PATIENT WAS MEDICALLY AFFECTED AS TREATMENT WAS NOT GIVEN, AND THEY HAD TO READMINISTER THE FOLLOWING DAY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AND NO PATIENT HARM AND INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376222 ↗
• MalfunctionFeb 3, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT CAME FOR A CADD UNHOOK. THE CHEMOTHERAPY PUMP SHOWED 4.6MLS LEFT TO BE INFUSED AND CADD PUMP WAS PRIMED. WHEN THEY WERE LOOKING AT THE CHEMOTHERAPY MEDICATION BAG, THERE WERE APPROXIMATELY 100MLS LEFT. AS THEY DOUBLE CHECKED, THE RATE OF 20.8 MILLILITERS PER HOUR WAS PROGRAMED CORRECTLY WITH A VOLUME OF 500 MILLILITERS. THE STARTING VOLUME WAS 500 ML. A CONTINUOUS INFUSION RATE OF 20.8 ML PER HOUR HAD BEEN PROGRAMMED. RESERVOIR VOLUME: PUMP STATED THERE WERE 4.6ML LEFT AT TIME OF DISCONNECT (24 HOURS AFTER HOOKING UP) BUT 100ML LEFT IN BAG. GIVEN VOLUME: PUMP STATED 495.6ML (AS 4.6ML LEFT) BUT ONLY ABOUT 400 ML WAS GIVEN. THE AMOUNT OF THE MEDICATION REMAINING IN CASSETTE DID NOT MATCH THE RESERVOIR VOLUME DISPLAYED ON PUMP. THEY SWITCHED OUT THE PUMP AND UTILIZED THE SAME CASSETTE. THEY TOOK ABOUT 3 HOURS AT 33.3ML PER HOUR. THE AMOUNT REMAINING WAS 100ML. THE LENGTH OF INFUSION TOOK 27 HOURS BECAUSE OF AN INCREASED RATE AT THE END (33.3ML PER HOUR). A CLOSED SYSTEM TRANSFER DEVICE WAS USED TO FILL THE CASSETTE. THEY HAD TO INCREASE PATIENT'S CHEMOTHERAPY RATE TO COMPLETE BY THE TIME THE CLINIC CLOSED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248962 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TUBING LEAKED AT THE FILTER WHEN THEY USED WITH CHEMO MEDICINES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854057 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS FURTHER REPORTED THAT THE SUSPECTED DEVICE WAS USED PARTICULARLY BECAUSE IN CERTAIN CONCENTRATIONS, ETOPOSIDE REQUIRES USE OF AN IN-LINE FILTER. ADDITIONALLY, IT WAS NOTED THAT THE TUNNELED CENTRAL CATHETER WAS IN PLACE (DOUBLE LUMEN) THAT WAS WORKING AS EXPECTED FOR THE ADMINISTRATION OF CONTINUOUS INFUSION CHEMOTHERAPY COCKTAIL. THE PATIENT HAD UNDERGONE TREATMENT RELATED BLOOD TESTS BUT NO TESTS FOR CHEMOTHERAPY LEAK. THE ISSUE WAS RESOLVED AS PHARMACY/NURSING TEAM STOPPED USING THIS SPECIFIC CADD ADMINISTRATION SET THAT INCLUDED AN IN-LINE FILTER TO ADMIN THIS REGIMEN. THE TEAM OPTED TO USE THE ADMINISTRATION SET THAT DID NOT INCLUDE IN-LINE FILTER. PHARMACY TEAM RECALCULATED DILUTION TO CHANGE CONCENTRATION SO NO IN-LINE FILTER WOULD BE REQUIRED FOR ETOPOSIDE ADMINISTRATION. NO FURTHER LEAKS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795515 ↗
• MalfunctionDec 1, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE ADMIN SET CAME APART AT THE FILTER DUE TO A POSSIBLE TEAR. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680547 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS LEAKING OVERNIGHT AND SUBSEQUENTLY TRIGGERED AN AIR IN-LINE ALARM ON THE PATIENT'S PUMP. PER REPORTER, THE INFUSION RATE WAS 20.8 MILLILITERS PER HOUR WITH A TOTAL VOLUME OF 500 MILLILITERS. REPORTER ALLEGED THAT THE TUBING WAS FLUSHED AND TESTED, AND LEAKAGE WAS OBSERVED AT THE AIR FILTER IN THE FORM OF DROPLET FORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427457 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE TUBING WAS LEAKING OVERNIGHT AND SUBSEQUENTLY TRIGGERED AN AIR IN-LINE ALARM ON THE PATIENT'S PUMP. PER REPORTER, THE INFUSION RATE WAS 20.8 MILLILITERS PER HOUR WITH A TOTAL VOLUME OF 500 MILLILITERS. REPORTER ALLEGED THAT THE TUBING WAS FLUSHED AND TESTED, AND LEAKAGE WAS OBSERVED AT THE AIR FILTER IN THE FORM OF DROPLET FORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427375 ↗
• MalfunctionOct 23, 2025Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  IT WAS REPORTED THAT LINATUMOMAB WAS LEAKING AT THE POINT OF THE 0.2-MICRON AIR-ELIMINATING FILTER. THIS HAD SIGNIFICANT IMPACT FOR THE PATIENT AS THEIR MEDICATION WAS INTERRUPTED FOR MORE THAN 12 HOURS PATIENT HAD TO SPEND AN EXTRA DAY IN HOSPITAL. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367510 ↗
• MalfunctionSep 11, 2025Disconnection; Material Separation; Disconnection; Material Separation

  IT WAS REPORTED THAT THE TUBE DISCONNECTED AT THE FILTER SITE. THE DEVICE WAS USED FOR THREE DAYS. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027147 ↗
• MalfunctionAug 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PRIMING THE MEDICATION LEAKED THROUGH THE TUBE AT THE PART THAT CLIPS INTO THE CADD PUMP, AS A RESULT, THE BAG HAD TO BE RE-SPIKED WITH NEW TUBING. AS THE PRODUCT WAS INSPECTED, THERE WAS LEAKING AND A HOLE COULD NOT BE SEEN. THE EVENT OCCURRED ON (B)(6) 2025. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22918818 ↗
• MalfunctionAug 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PRIMING, THE MEDICATION LEAKED THROUGH THE CADD TUBING AT THE PART THAT CLIPS INTO THE CADD PUMP. AS A RESULT, THE BAG HAD TO BE RE-SPIKED WITH NEW TUBING. UPON INSPECTION OF PRODUCT, IT WAS LEAKING AND A HOLE WAS NOT VISIBLE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916440 ↗
• MalfunctionAug 28, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT AN ESTIMATED 30¿50 ML OF CHEMOTHERAPY REMAINED IN THE PUMP, THOUGH THE EXACT AMOUNT WAS UNKNOWN. THE PUMP STARTED WITH 600 ML AT A CONTINUOUS RATE OF 25 ML/HR. BOTH RESERVOIR AND TOTAL VOLUME GIVEN WERE RECORDED AS 600 ML. THE PATIENT HAD BEEN MEDICALLY AFFECTED, REQUIRING AN ADDITIONAL 1¿2 HOURS OF INFUSION TIME TO COMPLETE THE TREATMENT. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911585 ↗
• MalfunctionAug 21, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP WAS ALARMINGLY HIGH PRESSURE. THE PUMP WAS CONNECTED TO THE PATIENT. THE PATIENT WAS NOT AFFECTED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE CLINIC. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860319 ↗
• MalfunctionAug 19, 2025Excess Flow or Over-Infusion; Air/Gas in Device; Excess Flow or Over-Infusion; Air/Gas in Device

  IT WAS REPORTED THAT THE DEVICE HAD ENDED APPROXIMATELY FOUR HOURS EARLIER THAN EXPECTED AND HAD ALARMED AIR IN LINE. UPON ARRIVAL, THE INFUSION BAG HAD BEEN FOUND EMPTY. THE CONTINUOUS INFUSION HAD BEEN SET AT A RATE OF 2.2 ML/HR, WITH A RESERVOIR VOLUME OF 100 ML. A TOTAL OF 89.8 ML HAD BEEN ADMINISTERED. THE INTENDED LENGTH OF INFUSION HAD BEEN 46 HOURS. 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 22838903 ↗
• MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE DRAINING THE BAGS OF MEDICATION FOLLOWED WITH A SALINE FLUSH THEN DRAINED, IT WAS NOTED DROPLETS COMING OUT OF THE AIR-ELIMINATING TUBING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739312 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORTER STATED THAT THEY HAD LEAKING AT THE AIR-ELIMINATING. THE PATIENT ON 24H INFUSION OF EPOCH, NOTED WETNESS AT THE FILTER. PICTURE PROVIDED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708312 ↗

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