Power-Trialysis catheter 5603200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741041860), received between Jan 23, 2018 and May 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Product Quality Problem; Material Deformation

  IT WAS REPORTED GUIDE WIRE WOULD NOT ADVANCE, RESISTANCE MET AT TIP OF CATHETER, ALL PORTS FLUSHED WITH STERILE WATER WITH NO ISSUES BUT IT SEEMED THE TIP OF THE CATHETER MAY HAVE BEEN FUSED. NO HARM TO THE PATIENT. ADDITIONALLY THE HOLDER WAS DEFECTIVE WHERE THE PLASTIC TUBING MEETS THE BLUE PLASTIC. GUIDEWIRE NEEDED TO BE REMOVED FROM THE HOLDER TO ADVANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319063 ↗
• MalfunctionMay 2, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED BY THE CUSTOMER " THE CLINICIAN PLACED THE LINE, CATHETER WENT OVER THE WIRE FINE BUT WHEN SHE ATTEMPTED TO REMOVE THE WIRE IT STUCK INSIDE THE DISTAL PORT. THEY TRIED MULTIPLE TIMES TO REMOVE THE WIRE AND ENDED UP HAVING TO PULL THE LINE AND WIRE AS 1 UNIT FOR FEAR OF SHEARING THE WIRE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855452 ↗
• MalfunctionMar 18, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "THE CLINICIANS STATED THAT THEY CANNOT FEED THE WIRE THROUGH THE PORT UPON INSERTION DUE TO FRAYING OF THE WIRE ITSELF." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13806599 ↗
• MalfunctionMar 18, 2022Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  IT WAS REPORTED "THE CLINICIANS STATED THAT THEY CANNOT FEED THE WIRE THROUGH THE PORT UPON INSERTION DUE TO FRAYING OF THE WIRE ITSELF." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13806598 ↗
• MalfunctionJan 23, 2018Detachment Of Device Component; Device Slipped

  IT WAS REPORTED THAT THE CATHETER CAME OUT AFTER BEING SECURED BY THE DETACHABLE SUTURE WINGS. THE FACILITY STATED THAT THE SUTURE PART ON THE SECUREMENT DEVICE OF THE CATHETER HAS A DETACHABLE PIECE THAT COMES OFF AND THE CATHETER CAN MOVE THROUGH THE PIECE. THE SUTURE SITE ATTACHED TO THE CATHETER ALSO SPINS AND CAN LEAD TO CATHETER DISLODGEMENT. THEY STATE THAT IT HAD HAPPENED PREVIOUSLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7212396 ↗