Power-Trialysis catheter 5618240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741042003), received between Sep 9, 2020 and Jul 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE HUB LEAKED AIR AND BLOOD. THIS HAPPENED DESPITE THEIR STANDARD PRACTICE OF FLUSHING OUT CLOTS MID PROCEDURE; NOTHING UNUSUAL, NOTHING AGGRESSIVE. THE LEAK ONLY CAME TO THEIR KNOWLEDGE WHEN THEY KEPT ASPIRATING AIR WHILE PERFORMING A FEMORAL VENOUS PUNCTURE ¿ ONCE THE NEEDLE GOES IN AND THEY START TO ASPIRATE, IMMEDIATELY AIR IS ASPIRATED, RECURRENTLY. LEADING TO THE PATIENT POKED MANY TIMES, AS THEY KEPT THINKING CONNECTION IS LOOSE. BUT THAT¿S NOT THE CASE. AND AFTER THAT ¿ THEY TRIED TO FLUSH, AND THE HUB LEAKED BLOOD AND SALINE. PATIENT STATUS/INTERVENTION : PATIENT IS FINE. CHANGED NEW SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122475 ↗
• MalfunctionSep 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER TWISTS OR EXPANDS BEFORE INTRODUCTION. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512110 ↗
• MalfunctionSep 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER TWISTS OR EXPANDS BEFORE INTRODUCTION. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512071 ↗
• MalfunctionSep 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER TWISTS OR EXPANDS BEFORE INTRODUCTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512059 ↗