CADD 21-7363-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 15019517161960), received between Aug 6, 2020 and Jul 3, 2026 — classified as 1 injury, 171 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (36 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE NURSE THAT A CRACK WAS IDENTIFIED IN THE COIL OF THE CADD ADMINISTRATION SET, WHICH MAY HAVE RESULTED IN THE PATIENT RECEIVING ONLY APPROXIMATELY HALF OF THE PRESCRIBED VANCOMYCIN DOSE. THE NURSING STAFF HAD PREVIOUSLY REPLACED THE CADD ADMINISTRATION SET ON (B)(6) 2026. ON (B)(6) 2026, LEAKAGE FROM THE LINE WAS OBSERVED. UPON IDENTIFICATION OF THE LEAK, THE ADMINISTRATION SET WAS REPLACED BY THE NURSING STAFF. HOWEVER, THE PATIENT RETURNED TO THE STU DUE TO CONTINUED LEAKAGE FROM THE CADD BAG. UPON FURTHER ASSESSMENT, A CRACK WAS CONFIRMED IN THE COIL OF THE CADD ADMINISTRATION SET. IT WAS DETERMINED THAT THE COMPROMISED LINE MAY HAVE RESULTED IN PARTIAL DELIVERY OF THE PRESCRIBED VANCOMYCIN DOSE. THE EVENT INVOLVED THE PATIENT; HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703766 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629392 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629343 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621811 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621418 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621367 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621356 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD ADMINISTRATION SET WAS DEFECTIVE, WITH TUBING LEAKS RESULTING IN DRIPPING. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT HARM OR INJURY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621253 ↗
• MalfunctionJan 28, 2026Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBING OCCLUSION DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201563 ↗
• MalfunctionJan 28, 2026Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBING OCCLUSION DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201444 ↗
• MalfunctionJan 28, 2026Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBING OCCLUSION DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201429 ↗
• MalfunctionJan 28, 2026Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBING OCCLUSION DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201172 ↗
• MalfunctionJan 28, 2026Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBING OCCLUSION DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201149 ↗
• MalfunctionJan 28, 2026Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBING OCCLUSION DURING INFUSION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200953 ↗
• MalfunctionNov 17, 2025False Alarm; Material Integrity Problem; False Alarm; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN UPSTREAM OCCLUSION WITHOUT ANY APPARENT OCCLUSION. THE TUBING WAS REMOVED AND REINSTALLED SEVERAL TIMES AND THE PUMP, ALSO TURNED OFF AND ON AGAIN SEVERAL TIMES, BUT THE ALARM WAS STILL PRESENT. IT WAS NECESSARY TO CHANGE THE TUBING, THE PRODUCT THAT WAS INSIDE WAS LOST FOR THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572147 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE TIME OF PURGING THE TUBING, THE DROPS DRIPPED FROM THE TUBING FILTER. THE NURSE HAD TO CHANGE TUBING AND PREPARE A NEW INFUSION LINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570163 ↗
• MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHEMO BAG WAS LEAKING. PATIENT FOUND A SMALL CRACK IN THE FILTER OF THE TUBING AND THERE WERE VISIBLE DROPS COLLECTING ON THE OUTSIDE OF THE FILTER. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026089 ↗
• MalfunctionJul 14, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE PUMP HAD RECURRING AIR IN LINE ERRORS WHILE TRYING TO INFUSE ANTIBIOTICS. THERE WAS NO DELAY OF THERAPY. THE PRODUCT FAULT APPEARS TO OCCUR BETWEEN DOSES OF EVERY 8 HOURS ANTIBIOTICS. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502504 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE TUBING AT THE CASSETTE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292952 ↗
• MalfunctionJun 5, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE ADMIN SET IS CONNECTED, THE CADD SOLIS VIP IMMEDIATELY GIVES A LOW-PRESSURE ALARM AND PREFILLING IS NOT POSSIBLE. THE INCIDENT OCCURRED IMMEDIATELY DURING USE AND WAS OBSERVED BY A HEALTHCARE PROFESSIONAL AT THE PATIENT'S HOME. MULTIPLE ATTEMPTS AT VENTING HAVE BEEN MADE. THE ERROR ALWAYS OCCURS DURING THE PRE-FILLING PROCESS USING THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153701 ↗
• MalfunctionJun 5, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE ADMIN SET IS CONNECTED, THE CADD SOLIS VIP IMMEDIATELY GIVES A LOW-PRESSURE ALARM AND PREFILLING IS NOT POSSIBLE. THE INCIDENT OCCURRED IMMEDIATELY DURING USE AND WAS OBSERVED BY A HEALTHCARE PROFESSIONAL AT THE PATIENT'S HOME. MULTIPLE ATTEMPTS AT VENTING HAVE BEEN MADE. THE ERROR ALWAYS OCCURS DURING THE PRE-FILLING PROCESS USING THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153458 ↗
• MalfunctionJun 5, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE ADMIN SET IS CONNECTED, THE CADD SOLIS VIP IMMEDIATELY GIVES A LOW-PRESSURE ALARM AND PREFILLING IS NOT POSSIBLE. THE INCIDENT OCCURRED IMMEDIATELY DURING USE AND WAS OBSERVED BY A HEALTHCARE PROFESSIONAL AT THE PATIENT'S HOME. MULTIPLE ATTEMPTS AT VENTING HAVE BEEN MADE. THE ERROR ALWAYS OCCURS DURING THE PRE-FILLING PROCESS USING THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153452 ↗
• MalfunctionJun 5, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE ADMIN SET IS CONNECTED, THE CADD SOLIS VIP IMMEDIATELY GIVES A LOW-PRESSURE ALARM AND PREFILLING IS NOT POSSIBLE. THE INCIDENT OCCURRED IMMEDIATELY DURING USE AND WAS OBSERVED BY A HEALTHCARE PROFESSIONAL AT THE PATIENT'S HOME. MULTIPLE ATTEMPTS AT VENTING HAVE BEEN MADE. THE ERROR ALWAYS OCCURS DURING THE PRE-FILLING PROCESS USING THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153438 ↗
• MalfunctionJun 5, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE ADMIN SET IS CONNECTED, THE CADD SOLIS VIP IMMEDIATELY GIVES A LOW-PRESSURE ALARM AND PREFILLING IS NOT POSSIBLE. THE INCIDENT OCCURRED IMMEDIATELY DURING USE AND WAS OBSERVED BY A HEALTHCARE PROFESSIONAL AT THE PATIENT'S HOME. MULTIPLE ATTEMPTS AT VENTING HAVE BEEN MADE. THE ERROR ALWAYS OCCURS DURING THE PRE-FILLING PROCESS USING THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153435 ↗
• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK HAD OCCURRED. THE INCIDENT OCCURRED DURING USE WITH THE PATIENT AND NURSE AT THE PATIENT'S HOME. THE EVENT IS THAT HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013217 ↗

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