CADD 21-7052-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 10610586020346), received between Jun 20, 2018 and Apr 8, 2026 — classified as 3 injuries, 138 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (24 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 141 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER OF THE DEVICE WAS LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821936 ↗
• MalfunctionNov 11, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS STATED THAT THE LINE IS NOT PRIMING AND A MESSAGE OF AN OCCLUSION SHOWS ON THE PUMP. AN ALTERNATIVE BATCH WAS USED AND THEY WERE OK. A REPLACEMENT PUMP WAS SENT BUT THE ERROR WAS STILL OCCURRING WITH THIS BATCH NUMBER. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE EVALUATION REVEALED THAT DURING FUNCTIONAL TESTING THE USED SAMPLE GAVE AN OCCLUSION ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522667 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO CADD EXTENSION SETS HAVE BEEN LEAKING BY THE "BUBBLE CATCHER". THE REPORTER STATED THE PATIENT WASN'T AWARE AT FIRST UNTIL THEY NOTICED LEAKING ON THEMSELVES SO THEY WERE NOT SURE HOW LONG IT HAD BEEN LEAKING FOR. THE EVENT OCCURRED DURING PATIENT USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796870 ↗
• MalfunctionJun 20, 2025Radiation Leak; Radiation Leak

  IT WAS REPORTED THAT A RECENT CLINICAL INCIDENT INVOLVED A PATIENT WHO HAD BEEN DISCHARGED FOR CHEMOTHERAPY TREATMENT WITH AN EXTENSION SET. THE PATIENT RETURNED TO THE HOSPITAL DUE TO LEAKAGE OF CHEMOTHERAPY FROM THE FILTER MEMBRANE OF THE EXTENSION SET. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301290 ↗
• MalfunctionDec 4, 2024Failure to Prime; Failure to Infuse; Obstruction of Flow; Failure to Prime; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE EXHIBITED AN OCCLUSION ALARM IMMEDIATELY ON USE AND THE PATIENT WAS UNABLE TO PRIME THROUGH THE PUMP. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843123 ↗
• MalfunctionOct 11, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A HIGH PRIORITY ALARM DURING PRIMING FOLLOWED BY AN OCCLUSION BUT CLEARED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427290 ↗
• MalfunctionSep 30, 2024Complete Blockage; Failure to Infuse; Complete Blockage; Failure to Infuse

  IT WAS REPORTED THAT THE PATIENT WAS WITHOUT DRUG FOR TWENTY MINUTES AS THE DEVICE WAS NOT WORKING. PER REPORTER THE DEVICE EXHIBITED A "HIGH PRIORITY ALARM". THE DEVICE HAD BEEN CHANGED TO A NEW CASSETTE THAT WEEKEND, BUT IT BEGAN ALARMING WHILE THE PATIENT WAS IN TOWN. THE HOME SCREEN INDICATED A HIGH PRIORITY ALARM. DOWNSTREAM OCCLUSION AND DID NOT CLEAR FOR TWENTY MINUTES. THE REPORTER FURTHER NOTED THAT TROUBLESHOOTING WAS PERFORMED BY THE PATIENT WHERE THEY CHANGED TO A DIFFERENT DEVICE, INFUSION LINE BATCH, CASSETTE BATCH AND THE DEVICE IN AN EFFORT TO ISOLATE THE CAUSE. THE PATIENT WAS ABLE TO GET HOME AND RE-ESTABLISH THE INFUSION USING A NEW SYSTEM WITH NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20335229 ↗
• MalfunctionSep 25, 2024Complete Blockage; Failure to Infuse; Complete Blockage; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED RECURRENT DOWNSTREAM OCCLUSION ALARMS. IT WAS INITIALLY BELIEVED THAT THE ISSUES WERE CAUSED BY THE PUMPS AS WHEN THEY TRIED TO PRIME, THE PUMPS DID 0.1 ML THEN OCCLUDED. THE REPORTER NOTED THAT THIS ONLY HAPPENED WITH FLOW STOP CARTRIDGES AND HAPPENED SPORADICALLY. IT WAS DISCOVERED AFTERWARDS THAT THE EXTENSION SETS ACTUALLY CAUSED THE ISSUE BECAUSE A CLIENT HAD ALREADY TRIED EXCHANGING THE PUMPS IN ORDER TO SOLVE THE ISSUE. THE PATIENTS CHANGED MULTIPLE LINES BEFORE FINDING ONE THAT WORKED. IT WAS FURTHER NOTED THAT IT WAS STILL UNKNOWN WHETHER THE PUMPS HAD ISSUES AS WELL. THE ISSUE WAS DISCOVERED DURING SET UP. THERE WAS PATIENT INVOLVEMENT, AND THERE WAS NO SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304778 ↗
• MalfunctionSep 25, 2024Complete Blockage; Failure to Infuse; Complete Blockage; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A DOWNSTREAM OCCLUSION ALARM. PER REPORTER ALL THE FAULTY LINES WERE CAUSING THE ALARM. IT WAS INITIALLY BELIEVED THAT THE ISSUES WERE CAUSED BY THE PUMPS AS WHEN THEY TRIED TO PRIME, THE PUMPS DID 0.1 ML THEN OCCLUDED. THE REPORTER NOTED THAT THIS ONLY HAPPENED WITH FLOW STOP CARTRIDGES AND HAPPENED SPORADICALLY. IT WAS DISCOVERED AFTERWARDS THAT THE EXTENSION SETS ACTUALLY CAUSED THE ISSUE BECAUSE A CLIENT HAD ALREADY TRIED EXCHANGING THE PUMPS IN ORDER TO SOLVE THE ISSUE. IT WAS FURTHER NOTED THAT IT WAS STILL UNKNOWN WHETHER THE PUMPS HAD ISSUES AS WELL. THE ISSUE WAS DISCOVERED DURING SET UP AT THE PATIENT'S HOME. THERE WAS PATIENT INVOLVEMENT, AND THERE WERE NO SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304629 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Failure to Infuse; Obstruction of Flow; Fluid/Blood Leak; Failure to Infuse; Obstruction of Flow

  IT WAS STATED THAT ¿PATIENT (KN) MAINTAINING A CONTINUOUS PROSTACYCLIN INFUSION USING THE CADD SOLIS/CASSETTE, ATTEMPTED TO PRIME INFUSION LINE UNATTACHED ¿ AS FLUID ADVANCED ALONG THE LINE, AS IT REACHED THE IN-LINE MICRON FILTER AN OCCLUSION ALERT ¿RED SCREEN FLASHING ¿ OCCLUSION ALARM¿ CAME UP, ATTEMPTS TO RE-PRIME WERE MET WITH SAME AND THEN BLUE STRIP ON TOP OF SCREEN DOWNSTREAM OCCLUSION CLEARED¿. THE PROBLEM WAS FIXED BY CHANGING THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304344 ↗
• MalfunctionAug 8, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT KEPT GETTING A DOWNSTREAM OCCLUSION WHICH STOPPED IT FROM PRIMING. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM OR INTERVENTION REQUIRED AND THE PRODUCT WAS DISPOSED OF BY PATIENT SO IT CANNOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942678 ↗
• MalfunctionAug 8, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED, THAT PATIENT KEPT GETTING A DOWNSTREAM OCCLUSION. WHICH, STOPPED IT FROM PRIMING. THERE WAS NO PATIENT HARM OR INTERVENTION REQUIRED. AND THE PRODUCT WAS DISPOSED OF BY PATIENT. SO IT CANNOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942633 ↗
• MalfunctionJul 23, 2024Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT THE LINE THAT WOULD NOT PRIME. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811692 ↗
• MalfunctionJul 23, 2024Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT THE LINE THAT WOULD NOT PRIME. AN ALARM OCCURRED WITH THE DOWNSTREAM OCCLUSION, AND THE OPERATOR HAD TO REPEATEDLY PRESS "PRIME" UNTIL IT CLEARED. THE ALARM ALSO WENT OFF "3 OR 4 TIMES" WHEN CONNECTED TO THE PATIENT BEFORE RESOLVING FOR THE NEXT 24 HOURS. THERE WAS PATIENT INVOLVEMENT WITH NO PHYSICAL HARM BUT ANXIETY AND STRESS, LEADING TO A LOSS OF CONFIDENCE IN USING THE PUMP AND RESTRICTING TRAVEL PLANS. PHYSICAL HARM WAS AVOIDED BECAUSE THE PATIENT SWAPPED TO A DIFFERENT BATCH AND KEPT PRIMING THE LINE UNTIL THE ALARM CLEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811685 ↗
• MalfunctionOct 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THE DISPOSABLE HAD MEDICATION LEFTOVER AFTER THE DEVICE WAS DONE INFUSING. THE INFUSIONS WERE SLOW, RESULTING IN POSSIBLE RESIDUAL VOLUMES OF 12 ML, 15 ML, 16 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007282 ↗
• MalfunctionOct 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THE DISPOSABLE HAD MEDICATION LEFTOVER AFTER THE DEVICE WAS DONE INFUSING. THE INFUSIONS WERE SLOW, RESULTING IN POSSIBLE RESIDUAL VOLUMES OF 12 ML, 15 ML, 16 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007253 ↗
• MalfunctionOct 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THE DISPOSABLE HAD LEFTOVER MEDICATION AFTER THE DEVICE WAS DONE INFUSING. THE INFUSIONS WERE SLOW, RESULTING IN POSSIBLE RESIDUAL VOLUMES OF 12 ML, 15 ML, 16 ML. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007202 ↗
• MalfunctionJul 28, 2023Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THE EXTENSION SET IS "FAULTY". IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420313 ↗
• MalfunctionJul 28, 2023Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THE EXTENSION SET IS "FAULTY". IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420310 ↗
• MalfunctionJul 28, 2023Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED, THE EXTENSION SET IS "FAULTY". IT IS UNKNOWN, IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420308 ↗
• MalfunctionJul 28, 2023Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THE EXTENSION SET IS "FAULTY". IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420307 ↗
• MalfunctionApr 17, 2023Device Alarm System; Deformation Due to Compressive Stress; Device Alarm System; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PUMP WAS ALARMING WHEN CASSETTE WAS ATTACHED AND PRIMING. FIELD ENGINEER TESTED PUMPS AND THE PUMP OPERATED FINE. TESTED WITH TEST CASSETTE AND FUNCTIONED FINE. WHILE INSPECTING THE LINE, THE CUSTOMER NOTICED INDENTATIONS ON TWO AREAS SO THEY BELIEVE THE MALFUNCTION IS DUE TO THE EXTENSION LINE AND NOT THE CASSETTES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755171 ↗
• MalfunctionApr 4, 2023Device Alarm System; Failure to Deliver; Material Twisted/Bent; Device Alarm System; Failure to Deliver; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WERE CREASES IN THE TUBING AND THE PUMP WAS ALARMING BECAUSE NO DRUG WAS GETTING FROM THE CASSETTE TO THE PUMP AND THROUGH THE LINE. THE PATIENT WAS DELAYED SLIGHTLY IN REPLACING THEIR MEDICATION CASSETTE AS THEY HAD TO WASTE A SIGNIFICANT AMOUNT OF CASSETTES AND LINES TRYING TO FIND ONE THAT WORKED. THE PATIENT DID NOT GO WITHOUT TREATMENT FOR VERY LONG. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673764 ↗
• MalfunctionApr 4, 2023Device Alarm System; Failure to Deliver; Material Twisted/Bent; Device Alarm System; Failure to Deliver; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WERE CREASES IN THE TUBING AND THE PUMP WAS ALARMING BECAUSE NO DRUG WAS GETTING FROM THE CASSETTE TO THE PUMP AND THROUGH THE LINE. THE PATIENT WAS DELAYED SLIGHTLY IN REPLACING THEIR MEDICATION CASSETTE AS THEY HAD TO WASTE A SIGNIFICANT AMOUNT OF CASSETTES AND LINES TRYING TO FIND ONE THAT WORKED. THE PATIENT DID NOT GO WITHOUT TREATMENT FOR VERY LONG. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673705 ↗
• MalfunctionApr 4, 2023Device Alarm System; Inaccurate Delivery; Device Alarm System; Inaccurate Delivery

  IT WAS REPORTED THAT THERE WERE CREASES IN THE TUBING AND THE PUMP WAS ALARMING BECAUSE NO DRUG WAS GETTING FROM THE CASSETTE TO THE PUMP AND THROUGH THE LINE. THE PATIENT WAS DELAYED SLIGHTLY IN REPLACING THEIR MEDICATION CASSETTE AS THEY HAD TO WASTE A SIGNIFICANT AMOUNT OF CASSETTES AND LINES TRYING TO FIND ONE THAT WORKED. THE PATIENT DID NOT GO WITHOUT TREATMENT FOR VERY LONG. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673479 ↗