Skip to content

Duo-Flow® MCDLT4400Recalls & reported problems

Medical Components, Inc. · 11.5F X 20CM Duo-Flow® CATHETER TRAY · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908026443), received between May 10, 2018 and May 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 10, 2018Leak/Splash; Leak/Splash

    DIALYSIS TREATMENT COMPLETE WITHOUT ISSUE. DURING THE RETURN OF BLOOD FROM THE CIRCUIT TO THE PATIENT A LEAK WAS NOTED ON THE VENOUS (BLUE) PORT OF THE HD CATHETER WHERE THE BLUE HUB SITS INSIDE CLEAR RUBBER TUBING. SURGERY WAS CONSULTED AND REPAIRED THE LINE. THE LINE HAS BEEN ORIGINALLY INSERTED APPROXIMATELY 4 MONTHS EARLIER. POINT OF LEAKAGE MAY BE DUE TO CATHETER BENDING AT THE SITE DUE TO PATIENT'S HABITUS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7502054 ↗

Other Accessories, a-v shunt devices

All Accessories, a-v shunt devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.