CADD 21-7092-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10610586024177), received between Oct 17, 2019 and Sep 18, 2026 — classified as 96 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (54 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825358 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  It was reported that CADD Check valve Extension Set Y connection was leaking immediately on use. There was no patient involvement and harm. However, leakage may lead to exposure to blood, bodily fluids, or drugs, which could potentially result in infection for the patient or clinician.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819565 ↗
• MalfunctionJun 12, 2026Crack; Fluid/Blood Leak

  AN EVENT INVOLVED A SET, EXTENSION WHERE IT WAS REPORTED THAT THE CRACK FOUND AT IV FLUSHING CONNECTION PORT WHITE PORT COLOR IN RED WHILE IN USE WITH PATIENT. A CRACK MAY RESULT IN LEAKAGE, LEADING TO LOSS OF MEDICATION OR EXPOSURE OF THE DRUG. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484268 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE HAD BEEN BREAKAGE AND LEAKAGE AT THE PURPLE PORT. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL, AND THE EVENT OCCURRED AT THE HOSPITAL WHILE IN USE WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462746 ↗
• MalfunctionSep 3, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAD A FAULTY PATIENT-CONTROLLED ANALGESIA (PCA) CONNECTION RESULTING IN LEAKAGE AND FAULTY PATIENT-CONTROLLED ANALGESIA (PCA) CONNECTION BROKE APART. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY. THE EVENT OCCURRED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951456 ↗
• MalfunctionSep 2, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAD A FAULTY PATIENT-CONTROLLED ANALGESIA (PCA) CONNECTION RESULTING IN LEAKAGE AND FAULTY PATIENT-CONTROLLED ANALGESIA (PCA) CONNECTION BROKE APART. THERE WAS NO PATIENT INJURY. THE EVENT OCCURRED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946904 ↗
• MalfunctionAug 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A FAULTY PATIENT-CONTROLLED ANALGESIA (PCA) CONNECTION BROKE CAUSED A REVERSE FLOW OF BLOOD AND SUBSEQUENT LEAKAGE. AS A RESULT OF BLOOD CONTAMINATION, THE IMPACTED SETS WERE SENT BACK FOR FURTHER EXAMINATION AND ANALYSIS. THERE WAS NO PATIENT INJURY. THE EVENT OCCURRED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919673 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT WHILE THE PATIENT INFUSION WAS IN PROGRESS, THE TUBING BROKE AT THE Y-JUNCTION. THE TUBING WAS PROMPTLY REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798414 ↗
• MalfunctionJul 23, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PCA WAS STARTED IN THE MOT ON (B)(6) 2025. THE NEXT MORNING, DURING THE NURSE¿S ROUTINE ROUND, A LEAK WAS DISCOVERED. UPON EXAMINING THE TUBING, IT WAS FOUND THAT THE Y-CONNECTION ON THE CHECK VALVE EXTENSION TUBING WAS BROKEN, WHICH CAUSED THE LEAKAGE AT THE CONNECTION POINT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578598 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ONGOING PATIENT INFUSION, THE TUBING BROKE AT THE Y-JUNCTION. THE TUBING WAS PROMPTLY REPLACED WITH A NEW SET. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578357 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAD A LEAK DUE TO A MALFUNCTIONING VALVE. THERE WAS NO PATIENT INJURY. THE EVENT OCCURRED IMMEDIATELY ON USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485168 ↗
• MalfunctionJun 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A FAULTY PATIENT-CONTROLLED ANALGESIA (PCA) CONNECTION HAD RESULTED IN A LEAK. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137366 ↗
• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT CONTROLLED ANALGESIA (PCA) WAS LEAKING. THE EVENT OCCURRED IMMEDIATELY ON USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014412 ↗
• MalfunctionMay 8, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT "LEAK OBSERVED AT THE PURPLE CONNECTION (WITHOUT BEING ABLE TO HARDEN THE CONNECTION)." THE PATIENT WAS IN PAIN ALL AFTERNOON AND NEEDED SEVERAL PAINKILLERS BEFORE THE LEAK WAS DETECTED. THERE IS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT REPORTED.

  Patient problems: Pain

  MAUDE report 21989575 ↗
• MalfunctionMar 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A CHANGE OF THE TUBING OF THE ELECTRIC SYRINGE TODAY DURING THE CHANGING OF THE BANDAGE, AND THE SLEEVE OF THE SHIRT WAS SOAKED. THERE WAS A LEAK AT THE TUBING AT THE Y. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518777 ↗
• MalfunctionFeb 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE BAG WAS OPENED, THE TUBING WAS ALREADY MOUNTED AND THERE WAS A PART WITH A FIXED SCREW PITCH. AFTER CONNECTING THE POCKET, THERE WAS A SEEPAGE THROUGH THIS SCREW STEP. THE TUBING WAS CHANGED. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337865 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ¿WHEN THE BAG IS OPENED, THE TUBING IS ALREADY MOUNTED AND THERE IS A PART WITH A FIXED SCREW PITCH. OR AFTER CONNECTING THE POCKET, THERE WAS A SEEPAGE BY THIS SCREW STEP. I CHANGED THE TUBING". THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337173 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SETS EXHIBITED LEAKAGE. THERE WAS PATIENT INVOLVEMENT, THE PATIENT EXPERIENCED UNNECESSARY PAIN EXACERBATION.

  Patient problems: Pain

  MAUDE report 21061562 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SETS EXHIBITED LEAKAGE. THERE WAS PATIENT INVOLVEMENT, THE PATIENT EXPERIENCED UNNECESSARY PAIN EXACERBATION.

  Patient problems: Pain

  MAUDE report 21061529 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SETS EXHIBITED LEAKAGE. THERE WAS PATIENT INVOLVEMENT, THE PATIENT EXPERIENCED UNNECESSARY PAIN EXACERBATION.

  Patient problems: Pain

  MAUDE report 21061346 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ITEM HAD A LEAKAGE. PER REPORTER, THE EVENT OCCURRED DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486178 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HAD A TUBING LEAK. THIS EVENT OCCURRED AT THE PATIENT'S HOME. NO PATIENT HARM/ADVERSE EVENT REPORTED. PHOTOS OF THE TUBE LEAKING WERE PROVIDED FOR COMPLAINT REFERENCE. PER REPORTER, UPON EXAMINING THE TUBING, IT APPEARED THAT THE ISSUE WAS SURROUNDING THE LUER AT THE Y SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173347 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO SETS OF THE DEVICE WERE LEAKING. THE EVENT OCCURRED WHILE USE WITH PATIENT AT HOSPITAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002571 ↗
• MalfunctionJul 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWO SETS OF THE DEVICE WERE LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645352 ↗
• MalfunctionJan 2, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT WHEN USING THE CASSETTE EXTENDER WITH MULTIPLE PUMPS, THE PUMP WOULD EXHIBIT AN OCCLUSION ALARM. IT WAS STATED THAT THE PUMPS WORKED WITH OTHER CASSETTES WITHOUT ISSUE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18432150 ↗