DuoGlide catheter 5623150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741042010), received between Mar 3, 2026 and Apr 16, 2026 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THE CLINICIAN NOTICED THAT AFTER THE VENOUS SIDE WAS FLUSHED AND CLAMPED, THE CATHETER STARTED TO BACK FILL. THE CLINICIAN THEN ASPIRATED, FLUSHED WITH SALINE, RE-FLUSHED WITH HEPARIN AND RE-CLAMPED THE CATHETER. AFTER ALL OF THAT, THE CLINICIAN NOTICED THAT THE CATHETER WAS STILL BACKFILLING. LATER IT WAS NOTED THAT SOME SALINE WAS ON THE PATIENT SHIRT, AND THAT LOOKED AS IF IT HAD LEAKED AND CAUSED THEM TO INSPECT THE LINE CLOSER. ON CLOSER INSPECTION, THE VENOUS LUMEN HAD SMALL HOLE THAT THEY COULD SEE LEAKING BLOOD. NO INJURIES OR SERIOUS EVENT  RESULTED DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896735 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  IT WAS REPORTED PATIENT HAD THIS LINE PLACED IN THE RT IJ. AFTER THE LINE WAS LOCKED, THE PROVIDER NOTED THAT IT WAS BACK FILLING WITH BLOOD. CONCERNED FOR A LEAK, THE PROVIDER REPLACED THE LINE INTRAPROCEDURAL PRIOR TO SUTURING IN PLACE. THE NEW LINE APPEARED TO BE INTACT. DURING THE PATIENT'S TREATMENT AFTER THE PLACEMENT, WE WERE CONTACTED BY THE TEAM BECAUSE THE LINE WAS LEAKING. THE PATIENT WAS AGAIN BROUGHT TO THE IR DEPARTMENT AND A 3RD LINE WAS PLACED FROM A DIFFERENT LOT NUMBER AND WAS SUCCESSFUL. DELAY IN TREATMENT PLAN BY APPROXIMATELY 24HOURS. OVERNIGHT STAY WAS REQUIRED TO ENSURE TIMING OF TREATMENT TO PREVENT A 3 MONTH DELAY FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500448 ↗