CADD 21-7364-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 15019517191776), received between Dec 21, 2020 and Feb 2, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (38 reports).

3 other recalls cover devices cleared under the same FDA submission (K031361); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS STATED THAT THERE IS LEAKAGE AT THE FILTER DURING INFUSION. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236561 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS STATED THAT THERE IS LEAKAGE AT THE FILTER DURING INFUSION. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236146 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT SALINE PUMP TUBING WAS LEAKING NEAR THE CASSETTE. REPORTED INDICATED THAT THE TUBING THAT CAME OUT OF THE CASSETTE WAS LEAKING ON ONE SIDE. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983786 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INFUSION THERE WAS A TUBING BROKE AND LIQUID LEAKAGE. SOME LEAKS ARE SMALL, SO THEY ARE HARD TO NOTICE BY EYE AND ARE SOMETIMES NOTICED AFTER HOURS OF USE. THE EXACT LEAK SPOT IS NOT CERTAIN. THIS PARTICULAR ISSUE WAS DISCOVERED IN THE MORNING, SO THE PRODUCT HAD LEAKED DURING THE NIGHT. THE ISSUE IS SOLVED BY EXCHANGING BAGS AND FAULTY SETS. THERE WAS NO DELAY FOR THE SUBSEQUENT THERAPY. THERE WAS NO MEDICAL INTERVENTION. PATIENT SUFFERS FROM A RARE DISEASE AND THUS MUST HAVE A SUPPLEMENTARY 24-HOUR DIET VIA CVC (CENTRAL VENOUS CATHETER). PICTURE PROVIDED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646213 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE INFUSION AT NIGHT A FLUID LEAKAGE WAS FOUND AND THE THERAPY WAS THEREFORE INTERRUPTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496997 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT THE MOTHER OF THE PATIENT REPORTED THAT THE OUTFLOW AFTER JUST 1 HOUR OF INFUSION BEGAN TO DRIP. THERE WAS PATIENT INVOLVEMENT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491201 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PREPARING THE THERAPY, IT WAS FOUND 3 OUTFLOWS OF THE SAME BATCH LEAKING THE MEDICINE. THE ISSUE OCCURRED BEFORE USING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490850 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PREPARING THE THERAPY, IT WAS FOUND 3 OUTFLOWS OF THE SAME BATCH LEAKING THE MEDICINE. THE ISSUE OCCURRED BEFORE USING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490839 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PREPARING THE THERAPY, IT WAS FOUND 3 OUTFLOWS OF THE SAME BATCH LEAKING THE MEDICINE. THE ISSUE OCCURRED BEFORE USING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490834 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MULTIPLE PRODUCTS HAD LEAKS. SOME LEAKS ARE SMALL, SO THEY ARE HARD TO NOTICE BY EYE AND ARE SOMETIMES NOTICED AFTER HOURS OF USE. THE EXACT LEAK SPOT IS NOT CERTAIN. THERE WAS A THERAPY DELAY CAUSED BY THE PREPARATION OF A NEW BAG, WORSENED BY A SUBSEQUENT IDENTICAL ISSUE. THERE WAS NO MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279126 ↗
• MalfunctionAug 27, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE DEVICE PRESENTS A BROKEN OUTFLOW AT THE LEVEL OF THE WELD WITH THE TERMINAL. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903204 ↗
• MalfunctionAug 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ADMIN SET RUPTURED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795245 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE PARENTERAL FEEDING TUBING. THE REPORTER STATED THAT IT SEEMS THAT THE LEAK IS AT THE LEVEL OF THE FILTER. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT. OTHER PRODUCT INVOLVED IS A SMOFKABIVEN POUCH 986 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795068 ↗
• MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE OF PARENTERAL FLUID FROM THE OUTFLOW. THE EVENT TOOK PLACE DURING INFUSION AT THE CENTRAL POINT OF THE CASSETTE THAT CONNECTS TO THE INFUSION PUMP. THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM/EVENT REPORTED, THE PROBLEM WAS FIXED BY INTERRUPTING THE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345338 ↗
• MalfunctionJun 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CADD-SOLIS VIP PUMP HAD CONSISTENTLY PRODUCED DOWNSTREAM OCCLUSION ALARMS DURING THE PRIMING STEP (PRIOR TO PATIENT CONNECTION). ALL CLAMPS HAD BEEN CONFIRMED OPEN ON THE TUBING. THIS ISSUE HAD OCCURRED WITH MULTIPLE TUBING SETS FROM THE SAME LOT. THE REPORTER NOTED THAT THE PATIENT HAD BEEN USING THE SAME PUMP AND TUBING MODEL FOR SEVERAL MONTHS PRIOR TO THE ONSET OF THIS ISSUE. THE PATIENT HAD OCCASIONALLY BEEN ABLE TO INITIATE INFUSION SUCCESSFULLY. THE DOWNSTREAM OCCLUSION ALARM HAD RECURRED INTERMITTENTLY THROUGHOUT THE INFUSION PROCESS WHICH LED TO THE DISCONTINUATION OF THERAPY. THE INFUSION PROVIDED WAS SODIUM CHLORIDE 0.9% INJECTION SOLUTION 250 ML/HR. UP TO 4 TIMES PER DAY. THE REPLACEMENT OF THE PUMP WAS SENT TO THE PATIENT, AND IT RESOLVED THE ISSUE FOR THE TIME BEING. THERE WAS A DELAY IN THERAPY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297432 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO ADMIN SETS WERE LEAKING LIQUID AT THE LEVEL OF THE BOX. THE ISSUE OCCURRED DURING SETUP/PREPARATION, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190229 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO ADMIN SETS WERE LEAKING LIQUID AT THE LEVEL OF THE BOX. THE ISSUE OCCURRED DURING SETUP/PREPARATION, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190210 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT ANOTHER ADMINISTRATION LINE DRAIN BROKE DURING AN INFUSION. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549394 ↗
• MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK AT THE END OF THE TUBING ON THE CAP SIDE, WHERE THE SEAL WAS FOUND TO BE COMPLETELY DEFECTIVE. THE CAP ASSEMBLY, INCLUDING THE THREADED PART, HAD DISCONNECTED FROM THE TUBING, LEADING TO THE OBSERVED ISSUE. IT WAS REPORTED THAT THE ISSUE WAS FOUND DURING UNSPECIFIED LABORATORY TESTS. PER REPORTER THE PATIENT WAS UNABLE TO RECEIVE NUTRITION ON TWO OCCASIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507021 ↗
• MalfunctionJan 6, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED BY A NURSE THAT THE TREATMENT SCHEDULED TO BE ADMINISTERED DURING OVERNIGHT WAS NOT DELIVERED TO THE PATIENT. THE POCKET REMAINS FULL IN THE MORNING. THERE WAS PATIENT INVOLVEMENT, AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079730 ↗
• MalfunctionJan 3, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED BY A NURSE THAT THE TREATMENT WAS NOT DELIVERED THE DAY BEFORE. ONLY A SMALL PORTION OF THE BAG WAS ADMINISTERED. THERE WAS PATIENT INVOLVEMENT, AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069299 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT THE DRIP BROKE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026142 ↗
• MalfunctionDec 13, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INFUSION THE TUBE CONNECTED TO THE LUER LOCK COME OFF. THERE WAS PATIENT INVOLVEMENT. PATIENT WAS NOW IN THE HOSPITAL FOR AN EXAMINATION BECAUSE A HIGH FEVER APPEARED AFTER THIS EVENT.

  Patient problems: Fever

  MAUDE report 20929314 ↗
• MalfunctionNov 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FULL NUTRITION COULD BE ADMINISTERED TO THE PATIENT, BUT A LEAK WAS DETECTED IN THE FILTER. THE INCIDENT OCCURRED AT THE PATIENT'S HOME. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592386 ↗
• MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO INCIDENTS HAVE OCCURRED, AS A LEAK AT THE END OF THE TUBING ON THE CAP SIDE WAS NOTICED DURING TESTING. PER REPORTER, THE LEAKS CREATED AIR IN THE TUBING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470753 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.

• Z-0962-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
• Z-0148-2022 · Jul 14, 2020 · Terminated
  CADD Administration Sets, Model #21-7346-24
• Z-2589-2017 · May 15, 2017 · Terminated
  CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid