CADD 21-7391-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10610586027512), received between Aug 6, 2018 and Jun 12, 2026 — classified as 1 injury, 76 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (32 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026No Flow

  AN EVENT INVOLVED A SET, ADMIN, CADD, 108", SPIKE/M, CHECKVALVE, FS, TOTM 12/BX WHERE IT WAS REPORTED THAT THE ADMINISTRATION SET FAILED TO ALLOW ACTUAL FLUID INFUSION, WITH NO FLOW OBSERVED DURING PRIMING AND THE MEDICATION BAG REMAINING ALMOST FULL DESPITE DOCUMENTED DELIVERY. THE ISSUE RESOLVED IMMEDIATELY AFTER REPLACEMENT OF THE ADMINISTRATION SET. THE REPORTED OCCLUSION OR DEFECT IN THE ADMINISTRATION SET COULD RESULT IN INTERRUPTION OF THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484211 ↗
• MalfunctionAug 14, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CATHETER FROM THE PAIN PUMP SET WAS DISCONNECTED FROM THE CENTRAL VENOUS CATHETER AND LYING IN THE BED. IT APPEARED THAT THE TUBBING HAD BECOME DETACHED FROM THE CONNECTOR. THE ISSUE WAS RESOLVED BY REPLACING THE DAMAGED SET AND THE PATIENT WAS TREATED. THERE WAS PATIENT INVOLVEMENT, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809174 ↗
• MalfunctionJun 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THEY ARE GETTING UPSTREAM OCCLUSION ALARM ON THE PUMPS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198144 ↗
• MalfunctionMay 13, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE CADD PUMP SAID IT HAD 10MLS LEFT IN IT, BUT THE BAG ACTUALLY HAD APPROXIMATELY 100MLS IN IT. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012026 ↗
• MalfunctionMay 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT IT WAS REPORTED THAT THE ACUTE PAIN SERVICE HAD BEEN NOTIFIED OF TWO INCIDENCES IN THE LAST TWO WEEKS WHEN A PATIENT CONTROLLED ANALGESIA HAD NOT DELIVERED THE DOSE IT WAS PROGRAMMED TO DO. THE PATIENT CONTROLLED ANALGESIA PUMP HAD ALARMED SAYING THE OPIOID BAG WAS ALMOST EMPTY AND WHEN THE REGISTERED NURSE HAD GONE TO CHANGE THE BAG, THEY HAD NOTICED THAT THE OPIOID BAG WAS FULL AND THERE WAS A DISPARITY BETWEEN WHAT THE PUMP SAYS IT HAD DELIVERED AND WHAT WAS REMAINING IN THE OPIOID BAG. THE LAST INCIDENT OCCURRED ON SATURDAY MORNING. THEY CAN CONFIRM THAT THE BAG WAS CHANGED AT 0140 BY WARD STAFF AS THE PATIENT HAD USED THE AMOUNT IN THE BAG, SO THE PUMP AND LINE WAS WORKING THEN. THEN CHECKED THE AMOUNT DISCARDED FROM THE BAG AT THAT TIME. THE NEW BAG COMMENCED WAS 'SPIKED' PROPERLY BUT THERE WAS AIR IN THE LINE TO THE CASSETTE. THE PUMP HAD NOT ALARMED. THE PATIENT WAS SORE, AND THE PATIENT CONTROLLED ANALGESIA SAID THE PATIENT HAD USED 88MLS OF THE DRUG BUT WHEN THE REGISTERED NURSE CHANGED THE BAG THERE WAS 100MLS REMAINING. EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO PATIENT HARM/ADVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961939 ↗
• MalfunctionMay 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT IT WAS REPORTED THAT THE ACUTE PAIN SERVICE HAD BEEN NOTIFIED OF TWO INCIDENCES IN THE LAST TWO WEEKS WHEN A PATIENT CONTROLLED ANALGESIA HAD NOT DELIVERED THE DOSE IT WAS PROGRAMMED TO DO. THE PATIENT CONTROLLED ANALGESIA PUMP HAD ALARMED SAYING THE OPIOID BAG WAS ALMOST EMPTY AND WHEN THE REGISTERED NURSE HAD GONE TO CHANGE THE BAG, THEY HAD NOTICED THAT THE OPIOID BAG WAS FULL AND THERE WAS A DISPARITY BETWEEN WHAT THE PUMP SAYS IT HAD DELIVERED AND WHAT WAS REMAINING IN THE OPIOID BAG. THE LAST INCIDENT OCCURRED ON SATURDAY MORNING. THEY CAN CONFIRM THAT THE BAG WAS CHANGED AT 0140 BY WARD STAFF AS THE PATIENT HAD USED THE AMOUNT IN THE BAG, SO THE PUMP AND LINE WAS WORKING THEN. THEN CHECKED THE AMOUNT DISCARDED FROM THE BAG AT THAT TIME. THE NEW BAG COMMENCED WAS 'SPIKED' PROPERLY BUT THERE WAS AIR IN THE LINE TO THE CASSETTE. THE PUMP HAD NOT ALARMED. THE PATIENT WAS SORE, AND THE PATIENT CONTROLLED ANALGESIA SAID THE PATIENT HAD USED 88MLS OF THE DRUG BUT WHEN THE REGISTERED NURSE CHANGED THE BAG THERE WAS 100MLS REMAINING. EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO PATIENT HARM/ADVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961828 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING DISCONNECTS FROM THE CONNECTION AT THE PATIENT-TUBING CONNECTION AND WITH DIFFERENT PUMP. IT WAS STATED THAT THE SET WAS HAVING THE SAME ISSUE ABOUT THREE TIMES SINCE JULY, AND THE PROBLEM SEEMS TO OCCUR ONLY IN ONCOLOGY. PER REPORTER THE DEFECTIVE TUBING WAS CHANGED, AND IT WAS REPLACED LESS THAN 24 HOURS LATER BECAUSE IT WAS AGAIN DEFECTIVE. THE REPORTED ISSUE OCCURRED DURING USE ON THE PATIENT. NO SERIOUS CLINICAL CONSEQUENCES EXCEPT FOR LESS WELL-BALANCED PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308934 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING DISCONNECTS FROM THE CONNECTION AT THE PATIENT-TUBING CONNECTION AND WITH DIFFERENT PUMP. IT WAS STATED THAT THE SET WAS HAVING THE SAME ISSUE ABOUT THREE TIMES SINCE JULY, AND THE PROBLEM SEEMS TO OCCUR ONLY IN ONCOLOGY. PER REPORTER THE DEFECTIVE TUBING WAS CHANGED, AND IT WAS REPLACED LESS THAN 24 HOURS LATER BECAUSE IT WAS AGAIN DEFECTIVE. THE REPORTED ISSUE OCCURRED DURING USE ON THE PATIENT. NO SERIOUS CLINICAL CONSEQUENCES EXCEPT FOR LESS WELL-BALANCED PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308532 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING DISCONNECTS FROM THE CONNECTION AT THE PATIENT-TUBING CONNECTION AND WITH DIFFERENT PUMP. IT WAS STATED THAT THE SET WAS HAVING THE SAME ISSUE ABOUT THREE TIMES SINCE JULY, AND THE PROBLEM SEEMS TO OCCUR ONLY IN ONCOLOGY. PER REPORTER THE DEFECTIVE TUBING WAS CHANGED, AND IT WAS REPLACED LESS THAN 24 HOURS LATER BECAUSE IT WAS AGAIN DEFECTIVE. THE REPORTED ISSUE OCCURRED DURING USE ON THE PATIENT. NO SERIOUS CLINICAL CONSEQUENCES EXCEPT FOR LESS WELL-BALANCED PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308138 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP WAS BEEPING AND THE MEDICATION WAS EMPTY AND NEEDED A NEW BAG. PER REPORTER, IT WAS NOTICED THAT THE TUBING WAS LEAKING AT THE BOTTOM OF THE BASE, FROM THE TUBING IN THE CASSETTE. PER REPORTER, THERE WAS NO CONCERN WITH THE PUMP ITSELF AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21128583 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT NOTICED A PRODUCT LEAKING FROM THE TUBING AFTER THE DEVICE CASSETTE, DRIP BY DROP. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21059463 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION WAS LEAKING OUT THE SIDE BY THE BLACK CLIP. THE EVENT OCCURRED BEFORE INFUSION. THERE WAS NO PATIENT INVOLVE, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926054 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING WAS LEAKING DUE TO THE CLIP OF THE CASSETTE PUNCTURING THE TUBING. THE EVENT OCCURRED BEFORE INFUSION. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926033 ↗
• MalfunctionNov 18, 2024Fluid/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 20709658 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING EXHIBITED A LEAK DURING AN OCCLUSION TEST. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535515 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING EXHIBITED A LEAK DURING AN OCCLUSION TEST. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533008 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING EXHIBITED A LEAK DURING AN OCCLUSION TEST. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532770 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE NOTICED MEDICATION LEAKING UNDER THE PUMP, FROM THE BOTTOM OF THE TUBING CASSETTE AND ONTO THE FLOOR. THE PUMP VOLUME TO BE INFUSED (VTBI) DID NOT MATCH THE AMOUNT LEFT IN THE MEDICATION BAG. A NEW CADD PUMP WAS SET UP AND NEW INFUSION STARTED. APPROXIMATELY 2 HOURS LATER, THE PATIENT REPORTED HE WAS STILL IN PAIN. THE CADD SCREEN SHOWED THE PATIENT WAS RECEIVING MEDICATION. THE PHYSICIAN WAS NOTIFIED AND DISCONTINUED THE INFUSION ORDER. WHEN THE NURSES WERE ASPIRATING MEDICATION FROM THE TUBING TO WASTE, THEY FOUND MEDICATION IN THE CASSETTE AREA. UPON INSPECTION, IT LOOKED AS IF THE TUBING WAS PUNCTURED BY THE CLIP OF THE CASSETTE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 20455485 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE NOTICED MEDICATION LEAKING UNDER THE PUMP, FROM THE BOTTOM OF THE TUBING CASSETTE AND ONTO THE FLOOR. THE PUMP VOLUME TO BE INFUSED (VTBI) DID NOT MATCH THE AMOUNT LEFT IN THE MEDICATION BAG. A NEW CADD PUMP WAS SET UP AND NEW INFUSION STARTED. APPROXIMATELY 2 HOURS LATER, THE PATIENT REPORTED HE WAS STILL IN PAIN. THE CADD SCREEN SHOWED THE PATIENT WAS RECEIVING MEDICATION. THE PHYSICIAN WAS NOTIFIED AND DISCONTINUED THE INFUSION ORDER. WHEN THE NURSES WERE ASPIRATING MEDICATION FROM THE TUBING TO WASTE, THEY FOUND MEDICATION IN THE CASSETTE AREA. UPON INSPECTION, IT LOOKED AS IF THE TUBING WAS PUNCTURED BY THE CLIP OF THE CASSETTE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 20455331 ↗
• MalfunctionSep 9, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE PATIENT-CONTROLLED ANALGESIA (PCA) TUBING WAS FOUND IN THE PATIENT'S BED DISCONNECTED FROM MOUTHPIECE AND REMAINS AT OCTOPUS LEVEL. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176122 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S PCA PUMP HAD ALL LINES CHECKED, THE WRITER WAS ASSESSING THE PATIENT WHEN THEY NOTICED THE FLOOR WAS WET. PER REPORTER, WHEN THE WRITER WAS CHECKING FOR LEAKS, THEY NOTICED THE TUBING COMING OUT OF THE PCA PUMP (RIGHT AFTER THE FLOW REGULATOR) WAS LEAKING AT A VERY FAST RATE. THE PATIENT WAS IN PAIN DESPITE WRITER AND STAFF ENCOURAGING USING THE PCA.

  Patient problems: Pain

  MAUDE report 19833029 ↗
• MalfunctionMar 1, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DURING USE, THE DEVICE UNDER-INFUSED MEDICATION. THE ISSUE WAS DISCOVERED BY AN ANESTHESIOLOGIST WHILE THE PATIENT WAS HOOKED UP TO THE PUMP, DURING INFUSION. IT IS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT EFFECTS.

  Patient problems: Insufficient Information

  MAUDE report 18822730 ↗
• MalfunctionNov 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE VOLUME RECORDED AS INFUSED (39ML) AND VOLUME REMAINING IN BAG (61ML) WAS INCORRECT. THE PHYSICAL BAG VOLUME WAS STILL FULL. PER REPORTER THE PATIENT HAD BEEN ADMINISTERED OTHER MEDS SO NO IMMEDIATE DISCOMFORT RESULTED FROM THIS FAILED INFUSION. ANOTHER LINE FROM SAME BATCH WAS PRIMED AND WHILE SET ONLY REQUIRES 4.2ML TO COMPLETE PRIMING, PUMP RECORDED 8ML AND THE LINE WAS ONLY HALF PRIMED. SET FROM ANOTHER BATCH PRIMED SUCCESSFULLY AND TREATMENT RESUMED UNHINDERED. FIRST SET DISCARDED, SECOND SET IS AVAILABLE FOR MANUFACTURER TO REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231771 ↗
• MalfunctionOct 17, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE EXHIBITED AN UNDER DELIVERY. THE PATIENT EXPERIENCED EXTREME PAIN DUE TO NON DELIVERY OF MEDICATION. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO PRIME THE LINE AND AN OCCLUSION WAS CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 17952905 ↗
• MalfunctionMay 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE PROVIDING TEACHING ON PUMP WITH TUBING WAS TRYING TO DISPLAY CLAMP ALARM SO TUBING WAS CLAMPED AND THE INFUSION LIQUID LEAKED OUT THE SIDE OF THE CASSETTE AND NO CLAMP ALARM DISPLAYED OR EVER ALARMED AS INFUSION CONTINUED. OCCURRED DURING PRIMING AND INFUSION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876165 ↗

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