CADD 21-7346-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 634 adverse event reports that list this exact device (DI 15019517161953), received between Jan 2, 2020 and Sep 24, 2026 — classified as 2 injuries, 632 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (208 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 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.

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-0962-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 634 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888488 ↗
• MalfunctionJun 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INFUSION CADD ADMINISTRATION SET WAS LEAKING. THERE WERE A PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585735 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411594 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411358 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411185 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411001 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410307 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410089 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409883 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT WITHIN A 12-HOUR PERIOD, THE PATIENT¿S CADD PUMPS TRIGGERED AIR-IN-LINE ALARMS APPROXIMATELY FOUR TIMES, RESULTING IN THREE HOME CARE CALLOUTS AND A CLINIC VISIT AFTER THE FINAL ALARM. DURING DOSING, AFTER ABOUT ONE-THIRD OF THE INFUSION, BUBBLES WERE OBSERVED FILLING THE TUBING DOWNSTREAM OF THE PUMP UP TO THE AIR FILTER. THE INCIDENT INVOLVED THE PATIENT BUT CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409615 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A CADD ADMINISTRATION SET DURING INFUSION OF RECONSTITUTED ERTAPENEM 1 G WITH NACL USING A CADD ADMINISTRATION SET, THE SET REQUIRED APPROXIMATELY 10 ML TO FULLY PRIME INSTEAD OF THE EXPECTED 6 ML. INFUSION WAS INITIATED AND FLOW WAS INITIALLY VISUALIZED IN THE LINE. WITH APPROXIMATELY 17 ML REMAINING IN THE 110 ML BAG, THE CLIENT REPORTED THAT INFUSION IN THE LINE HAD STOPPED DESPITE THE PUMP REMAINING ACTIVE. UPON HANDLING THE MEDICATION BAG, LEAKAGE WAS OBSERVED AT THE JUNCTION WHERE THE BLUE PLASTIC CAP MET THE VIAL. THE INFUSION WAS STOPPED, AND HEALTH CARE PROFESSIONAL WAS CONTACTED AND ADVISED THAT NO FURTHER ACTION WAS REQUIRED. A MINI BAG FLUSH INFUSION WAS THEN INITIATED, AND FLOW WAS AGAIN VISUALIZED; HOWEVER, AFTER APPROXIMATELY 10 ML INFUSED, THE CLIENT REPORTED THE INFUSION HAD STOPPED WHILE THE PUMP REMAINED ACTIVE. THE INFUSION WAS STOPPED, THE LINE WAS FLUSHED WITH A SYRINGE, AND PATENCY WAS CONFIRMED. LEAKAGE MAY LEAD TO EXPOSURE AND CAN RESULT IN INTERRUPTION OF THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360022 ↗
• MalfunctionMay 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086355 ↗
• MalfunctionMay 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086338 ↗
• MalfunctionMay 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086296 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. FOR HAZARDOUS DOSES, PHASEAL OPTIMA CSTD WAS USED. THE TUBING WAS PRIMED VIA GRAVITY. THE RECENT INCREASE IN THESE OCCURRENCES WAS CONCERNING, AS NO CHANGES IN PRACTICE HAD BEEN MADE ON THEIR END AND THEIR TECHNIQUE HAD REMAINED THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783642 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. FOR HAZARDOUS DOSES, PHASEAL OPTIMA CSTD WAS USED. THE TUBING WAS PRIMED VIA GRAVITY. THE RECENT INCREASE IN THESE OCCURRENCES WAS CONCERNING, AS NO CHANGES IN PRACTICE HAD BEEN MADE ON THEIR END AND THEIR TECHNIQUE HAD REMAINED THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782026 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. FOR HAZARDOUS DOSES, PHASEAL OPTIMA CSTD WAS USED. THE TUBING WAS PRIMED VIA GRAVITY. THE RECENT INCREASE IN THESE OCCURRENCES WAS CONCERNING, AS NO CHANGES IN PRACTICE HAD BEEN MADE ON THEIR END AND THEIR TECHNIQUE HAD REMAINED THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781877 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. FOR HAZARDOUS DOSES, PHASEAL OPTIMA CSTD WAS USED. THE TUBING WAS PRIMED VIA GRAVITY. THE RECENT INCREASE IN THESE OCCURRENCES WAS CONCERNING, AS NO CHANGES IN PRACTICE HAD BEEN MADE ON THEIR END AND THEIR TECHNIQUE HAD REMAINED THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781766 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. FOR HAZARDOUS DOSES, PHASEAL OPTIMA CSTD WAS USED. THE TUBING WAS PRIMED VIA GRAVITY. THE RECENT INCREASE IN THESE OCCURRENCES WAS CONCERNING, AS NO CHANGES IN PRACTICE HAD BEEN MADE ON THEIR END AND THEIR TECHNIQUE HAD REMAINED THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781553 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THIS ISSUE OCCURRED WITH MULTIPLE LOT NUMBERS, AND YESTERDAY ALONE THERE WERE SEVEN INSTANCES REPORTED. FOR THIS THE REMAINING 5 DID NOT HAVE A REPORTED LOT NUMBER AVAILABLE. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. THE TUBING WAS PRIMED VIA GRAVITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780272 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THIS ISSUE OCCURRED WITH MULTIPLE LOT NUMBERS, AND YESTERDAY ALONE THERE WERE SEVEN INSTANCES REPORTED. FOR THIS THE REMAINING 5 DID NOT HAVE A REPORTED LOT NUMBER AVAILABLE. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. THE TUBING WAS PRIMED VIA GRAVITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780203 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THIS ISSUE OCCURRED WITH MULTIPLE LOT NUMBERS, AND YESTERDAY ALONE THERE WERE SEVEN INSTANCES REPORTED. FOR THIS THE REMAINING 5 DID NOT HAVE A REPORTED LOT NUMBER AVAILABLE. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. THE TUBING WAS PRIMED VIA GRAVITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780080 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THIS ISSUE OCCURRED WITH MULTIPLE LOT NUMBERS, AND YESTERDAY ALONE THERE WERE SEVEN INSTANCES REPORTED. FOR THIS THE REMAINING 5 DID NOT HAVE A REPORTED LOT NUMBER AVAILABLE. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. THE TUBING WAS PRIMED VIA GRAVITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779979 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THIS ISSUE OCCURRED WITH MULTIPLE LOT NUMBERS, AND YESTERDAY ALONE THERE WERE SEVEN INSTANCES REPORTED. FOR THIS THE REMAINING 5 DID NOT HAVE A REPORTED LOT NUMBER AVAILABLE. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. THE TUBING WAS PRIMED VIA GRAVITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779884 ↗
• MalfunctionApr 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT REACHED OUT YESTERDAY REGARDING ONGOING ISSUES WITH AIR APPEARING IN THE BAGS AFTER PRIMING AND PREPARATION WITHOUT ANY VISIBLE AIR HOWEVER, AFTER THE BAGS SAT FOR SOME TIME, VISIBLE AIR WAS OBSERVED. THIS ISSUE OCCURRED WITH MULTIPLE LOT NUMBERS, AND YESTERDAY ALONE THERE WERE SEVEN INSTANCES REPORTED. FOR THIS THE REMAINING 5 DID NOT HAVE A REPORTED LOT NUMBER AVAILABLE. THE PATIENT BELIEVED THE ISSUE WAS RELATED TO THE FILTER IN THE SET. THE TUBING WAS PRIMED VIA GRAVITY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779789 ↗

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-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