CADD 21-7083-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586021527), received between Jun 7, 2018 and Jul 20, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K991301); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DISPOSABLE CAUSED THE PUMP TO UNDER DELIVER MEDICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070993 ↗
• MalfunctionJul 20, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PUMP SAID IT HAD FINISHED INFUSION, 1/2 BOTTLE REMAINS THE TUBING WAS STILL FULL OF FLUID AND APPEARED TO BE PULLING IN A VACUUM. TUBING COULD NOT GET LIQUID OUT OF THE BOTTLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070975 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, LEAKING FROM THE FILTER AREA OF THE TUBING WAS NOTED. IT WAS REPORTED THAT PATIENT WAS RECEIVING CHEMOTHERAPY AT HOME AT APPROXIMATELY 41CC/HR. NO CLINICAL INJURY AND NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502312 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, LEAKING FROM THE FILTER AREA OF THE TUBING WAS NOTED. IT WAS REPORTED THAT PATIENT WAS RECEIVING CHEMOTHERAPY AT HOME AT APPROXIMATELY 41CC/HR. NO CLINICAL INJURY AND NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502311 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, LEAK WAS NOTED AT THE FILTER. NO PATIENT INJURY WAS REPORTED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500662 ↗
• MalfunctionApr 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, LEAK WAS NOTED AT THE FILTER. NO PATIENT INJURY WAS REPORTED. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500661 ↗
• MalfunctionJun 7, 2018Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE CADD PUMP READ "NO CASSETTE", BUT THE CASSETTE WAS INSERTED WHILE USING A CADD® ADMINISTRATION SET. NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991301. One submission often covers many models, so check the product and lot details in each record.

• Z-0775-2012 · Dec 9, 2011 · Terminated
  CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for us