CADD 21-7094-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10610586025266), received between Jun 1, 2017 and Oct 15, 2025 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K933390); 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PRESCRIBED DOSE HAD BEEN DELIVERED, YET 63 ML HAD REMAINED IN THE MEDICATION BAG. THERE WAS 0.1 ML LEFT TO BE INFUSED, DESPITE THE REMAINING VOLUME. A NEW PUMP HAD BEEN PLACED, AND THE PATIENT HAD RECEIVED THE REMAINING DOSE DURING THE CLINIC VISIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294346 ↗
• MalfunctionSep 16, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT TUBE DISCONNECTED NEAR THE PORT. BLOOD WAS OBSERVED WITHIN THE TUBING AND ON THE PATIENT'S SHIRT. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066727 ↗
• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK FROM THE 0.2 MICRON FILTER INFUSION SET. THE ISSUE OCCURRED DURING INFUSION. THERE WAS A THERAPY DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO INJURY, AND NO MEDICAL INTERVENTION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308617 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK FROM THE 0.2 MICRON FILTER INFUSION SET. THE ISSUE OCCURRED DURING INFUSION. THERE WAS A THERAPY DELAY. THERE WAS PATIENT INVOLVEMENT . THERE WAS NO INJURY AND NO MEDICAL INTERVENTION NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971882 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DRUG LEAK FROM THE 0.2-MICRON FILTER INFUSION SET. THERE WAS A DELAY IN THERAPY AND NO INJURY, AND NO MEDICAL INTERVENTION NEEDED. THE OUTFLOW CHANNEL WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945683 ↗
• MalfunctionDec 6, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, THAT THE PATIENT HAD STATED, THAT FREQUENT WARNINGS HAD BEEN RECEIVED ON THEIR CADD PUMPS, INCLUDING ¿UPSTREAM OCCLUSION,¿ ¿DOWNSTREAM OCCLUSION¿ AND ¿CASSETTE NOT ATTACHED¿. THERE WAS PATIENT INVOLVEMENT. AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865022 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IN 2 SETS, THERE WAS A SUDDEN LEAKAGE OF MEDICATION 24 HOURS AFTER THE INFUSION BEGAN. PER REPORTER, DURING THE BLINCYTO INFUSION THE SET STARTED TO DRIP AT THE FILTER, ON TWO SETS. THE EVENT HAPPENED IMMEDIATELY ON USE IN THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20621278 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IN 2 SETS MENTIONED, THERE WAS A SUDDEN LEAKAGE OF MEDICATION 24 HOURS AFTER THE INFUSION BEGAN. PER REPORTER, DURING THE BLINCYTO INFUSION THE SET STARTED TO DRIP AT THE FILTER, ON TWO SETS. THE EVENT HAPPENED IMMEDIATELY ON USE IN THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620937 ↗
• MalfunctionFeb 14, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DISPOSABLE CAUSED THE DEVICE TO EXHIBIT AN ERROR MESSAGE: CHECK FOR EMPTY TUBING OR RESERVOIR. TROUBLESHOOTING WAS PERFORMED BUT THE ALARM PERSISTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703706 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CONTINUOUS INFUSION OF BLINCYTO, A LEAK AT THE FILTER OCCURRED BEFORE THE END OF THE FOURTH DAY. PER REPORTER THE PATIENT HAD TO RETURN EARLY TO HAVE THE TUBING CHANGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777813 ↗
• MalfunctionAug 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DISPOSABLE TUBING WAS LEAKING AT THE FILTER WHILE IN USE. PATIENT USING BLINCYTO CONTINUOUS INFUSION. THE SAME PROBLEM OCCURRED LAST WEEK WITH TUBING FROM THE SAME LOT NUMBER. ADDITIONAL INFORMATION: PATIENT IS MONITORED BY A LOCAL NURSE VIA AN EXTERNAL SERVICE PROVIDER. THE BAG (WITH TUBING) IS INSERTED CONTINUOUSLY OVER A PERIOD OF 3 OR 4 DAYS. THE PATIENT HAD TO RETURN EARLIER TO CLINIC TO CHANGE HER EQUIPMENT. NO CLINICAL CONSEQUENCES FOR THE MOMENT AS THE EQUIPMENT HAS BEEN CHANGED THE 2 TIMES THERE WAS A LEAK. THE PATIENT IS TAKING OTHER MEDICATIONS, UNRELATED TO THE PRESENT INCIDENT: XANAX, IMOVANE, DEXERYL, PANTOPRAZOLE, MACROGOL, CONTRAMAL, WELLVONE, ZELITREX: ALL THESE TREATMENTS ARE PER THE CLINIC SUGGESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599389 ↗
• MalfunctionAug 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A BLINCYTO CASSETTE WAS CHANGED FOR A FOUR-DAY INFUSION AND ON THE THIRD DAY THE PATIENT RETURNED TO THE HOSPITAL TO REPORT A LEAK AT THE FILTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552610 ↗
• MalfunctionApr 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A THIRD INCIDENT OF LEAKING INFUSION AT THE SMALL ROUND FILTER OF THE TUBING AND THIS HAS BEEN SEVERELY AFFECTING PATIENT CARE. NO PATIENT INJURY REPORTED.

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

  MAUDE report 16816318 ↗
• MalfunctionApr 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DISPOSABLE LEAKED DURING THE NIGHT WHICH LED TO THE REPLACEMENT OF THE INFUSION, INITIALLY PREPARED FOR 96 HOURS, WITH A NEW 48-HOUR INFUSION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805281 ↗
• MalfunctionApr 21, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THE DISPOSABLE LEAKED AT THE FILTER DURING INFUSION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16786015 ↗
• MalfunctionNov 1, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THERE WERE MULTIPLE OCCLUSION ALARMS ON MULTIPLE PATIENT'S PUMPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712484 ↗
• MalfunctionJun 3, 2022Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THERE WAS A NON DISPOSABLE ERROR; 10.2ML STATED TO REMAIN - BUT NONE IN CASSETTE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593964 ↗
• MalfunctionMay 6, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED AN ADVERSE EVENT WHICH WAS EXPERIENCED IN RELATION TO A CADD ADMINISTRATION SET AT (B)(6). NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14310788 ↗
• MalfunctionApr 7, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT CADD ADMINISTRATION KIT, PUMP ALARMED AIR IN TUBING. NO FURTHER DETAILS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14043212 ↗
• MalfunctionMar 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKING WAS NOTED FROM THE TUBING CONNECTION TO BLACK PLASTIC CADD CONNECTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869496 ↗
• MalfunctionMar 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKING OCCURRED FROM TUBING CONNECTION TO BLACK PLASTIC CADD CONNECTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869456 ↗
• MalfunctionMar 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TUBING LEAKED FREQUENTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866214 ↗
• MalfunctionMar 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKING FROM THE TUBING OCCURRED FREQUENTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866144 ↗
• MalfunctionMar 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKING FROM THE TUBING OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865879 ↗
• MalfunctionMar 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS EXPERIENCING LEAKAGE THAT WAS SET NEAR THE FILTER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13849358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933390. One submission often covers many models, so check the product and lot details in each record.

• Z-2759-2017 · Dec 9, 2016 · Terminated
  Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.