CADD 21-7384-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586038488), received between Sep 15, 2023 and Dec 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EPIDURAL HIGH VOLUME ADMINISTRATION SET DISCONNECTED ITSELF FROM THE SYSTEM 1 PART OF THE EPIDURAL CATHETER. THERE WAS NO APPARENT DAMAGE TO EITHER THE CATHETER OR VOLUME ADMINISTRATION SET. IT WAS NOTED THAT IT WAS LEAKING AND NOTED IT WAS DISCONNECTED. ONE PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21041965 ↗
• MalfunctionSep 18, 2024Incomplete or Inadequate Priming; Incomplete or Inadequate Priming

  IT WAS REPORTED THAT THE DEVICE HAD ISSUES WHILE PRIMING THE CADD TUBING. THE CUSTOMER HAD PRIMED MANUALLY AS WELL AS BY USING THE PRIME FEATURE ON THE PUMP. THE CUSTOMER HAD TO PRIME MULTIPLE TIMES TO REMOVE ALL OF THE AIR AND MANY TIMES IT WAS VERY DIFFICULT TO DO SO. THIS WAS ESPECIALLY CONCERNING DUE TO THE AMOUNT OF MEDICATION THAT WAS BEING WASTED DURING PRIMING. PER REPORTER, THE CUSTOMER WAS ABLE TO REMOVE ALL AIR FROM THE TUBING VIA MANUALLY DEPRESSING THE GREEN FLOW STOP AND MANUALLY PRIMING THE AIR BUBBLES OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249521 ↗
• MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN EPIDURAL, A LEAK OCCURRED. PER REPORTER THE ADMINISTRATION SET HAD SHEARED OFF AND THE LEUR LOCK ADAPTOR WAS CONNECTED TO THE EPIDURAL LINE, BUT THE ADMINISTRATION SET HAD DISCONNECTED CAUSING THE LEAK. NO ADVERSE EFFECTS WERE REPORTED, ALTHOUGH REPORTER INDICATED A NEAR INCIDENT INVOLVING PATIENT SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761246 ↗

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