Power-Trialysis catheter 5608240Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741041914), received between Feb 2, 2018 and Apr 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED FOREIGN BODY CLEARLY VISIBLE BEFORE USE IN THE SEALED PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753399 ↗
• MalfunctionNov 22, 2023Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "WHEN INSERTING THE CATHETER OVER THE GUIDE WIRE, IT KINKED SUBCUTANEOUSLY TOGETHER WITH THE CATHETER. THE CATHETER REMOVED, LEAVING THE GUIDE WIRE IN PLACE (STILL CORRECTLY POSITIONED INTRAVASCULARLY). SLIGHTLY STRONGER TRACTION THAN NORMAL WAS APPLIED. SPIRAL FROM WHICH THE GUIDE WIRE IS MADE HAS STRETCHED INTO A THIN WIRE (SPIRAL WAS TWISTED OPEN)". 11/09/2023 - ADDITIONAL INFORMATION PROVIDED BY BD REP AS FAR AS WE CAN CURRENTLY JUDGE, THERE WERE NO CONSEQUENTIAL DAMAGES. THE CATHETER IS IN USE. ONLY THE WIRE WAS DAMAGED, NOT THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192963 ↗
• MalfunctionSep 26, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THE RESUSCITATOR ENCOUNTERED DIFFICULTIES DURING THE INSTALLATION OF THE DIALYSIS KT AND WHEN SHE WANTED TO REMOVE THE GUIDE, IT DETERIORATED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818898 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER IS FAULTY (DRUG LEAKAGE). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328040 ↗
• MalfunctionDec 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED INSERTION OF SHALDON FEMORALLY, PUNCTURE WITHOUT ANY PROBLEM AND ADVANCEMENT OF THE WIRE WITH CONTROL OF THE WIRE INTRAVASALLY, DILATATION WITHOUT ANY PROBLEM, WIRE ALWAYS FREELY MOVABLE DURING THIS TIME. NOW AN ATTEMPT TO SELDING THE CATHETER OVER THE WIRE IT WAS NOT POSSIBLE, BECAUSE THE WIRE (PART THAT WAS IN THE MUSCLE) HAS MASSIVE BENDS. IT ALSO SHOWS THAT THE WIRE KINKS AT THE SLIGHTEST TOUCH. CONSEQUENCE: IN A FULLY ANTICOAGULATED PATIENT, 2ND PUNCTURE, SAME BRAND BUT NEW SET - NO PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960877 ↗
• MalfunctionMay 1, 2020Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED: THE CUSTOMER HANDS OVER THE GUIDE WIRE OF A POWER TRIALYSIS CATHETER TO THE SALES REP. THIS WAS REMOVED AFTER THE CATHETER WAS SUCCESSFULLY PLACED IN THE FEMORAL ARTERY. THE GUIDE WIRE KINKED SEVERAL TIMES, AND THE WIRE PULLED APART. THE PATIENT WAS NOT HARMED. THE USERS ALSO REPORTED THAT THE ENCLOSED DILATOR SHOWS SMALL EDGES AT THE TIP. THIS HAS BEEN NOTICED SEVERAL TIMES. NO HARM TO THE PATIENT HERE EITHER. 4/27/2020-TWO SAMPLES WERE RETURNED. THIS REPORT ADDRESSES THE SECOND SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018313 ↗
• MalfunctionFeb 20, 2020Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED: THE CUSTOMER HANDS OVER THE GUIDE WIRE OF A POWER TRIALYSIS CATHETER TO THE SALES REP. THIS WAS REMOVED AFTER THE CATHETER WAS SUCCESSFULLY PLACED IN THE FEMORAL ARTERY. THE GUIDE WIRE KINKED SEVERAL TIMES, AND THE WIRE PULLED APART. THE PATIENT WAS NOT HARMED. THE USERS ALSO REPORTED THAT THE ENCLOSED DILATOR SHOWS SMALL EDGES AT THE TIP. THIS HAS BEEN NOTICED SEVERAL TIMES. NO HARM TO THE PATIENT HERE EITHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732314 ↗
• MalfunctionFeb 2, 2018Kinked; Difficult to Remove

  IT WAS REPORTED THAT THE GUIDEWIRE KINKED UPON INSERTION, WHICH LED TO THE PHYSICIAN NOT BEING ABLE TO INSERT THE POWER-TRIALYSIS CATHETER. THE PHYSICIAN REQUESTED A LESS MALLEABLE WIRE FROM THEIR CATH LAB TO THEN BE ABLE TO COMPLETE THE INSERTION PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7239269 ↗