Power-Trialysis catheter 5613200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741041952), received between Feb 11, 2016 and Mar 21, 2019 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionMar 21, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT AT THE START OF THE RN'S SHIFT, IT WAS NOTED THE PATIENT'S TRIALYSIS LINE WAS SUTURED BUT THAT THE HUB WASN¿T SUTURED AND SO THEY ATTEMPTED TO SECURE IT BETTER WITH STEREO STRIPS. IT WAS STATED AROUND 0200, THE RNS WERE REINTUBATING AND POSITIONING THE PATIENT AND HIS LINE BECAME DISLODGED. THE RN WENT TO PREPARE TO PUSH DRUGS AND NOTICED IT WAS OUT ABOUT AN INCH AND A HALF FROM PREVIOUS LOCATION. AFTER REMOVING, RNS NOTED THAT THE SUTURING ADAPTOR HAD MOVED FROM IT¿S ORIGINAL LOCATION (PICTURE 1), TO FURTHER DOWN THE LINE (PICTURE 2). RN STATES SHE DOESN'T KNOW IF IT WAS INTENTIONALLY SUTURES THAT WAY BEFORE BUT THAT IT CREATED AN UNSAFE SITUATION AS THE LINE MOVED POSITION WHILE CVVHD WAS RUNNING. A NEW CATHETER WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441848 ↗
• InjuryJun 8, 2017Appropriate Device Problem Term/Code Not Available

  FACILITY REPORTED TO THE SALES REP THAT THE INFECTED PORT WAS REMOVED. NO OTHER INFORMATION WAS REPORTED, BUT HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 6623953 ↗
• MalfunctionFeb 11, 2016Break

  IS REPORTED, THAT DURING THE PROCEDURE, THE GUIDEWIRE "CAME FLYING OUT OF THE DEVICE", THIS TOOK PLACE WHILE TRYING TO FEED AND RETRACT THE GUIDEWIRE. RETURNED SAMPLE HAS A BROKEN CORE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5430715 ↗