Power-Trialysis catheter 5608150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741041891), received between Dec 3, 2021 and Sep 30, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  It was reported while inserting the dialysis catheter, the guidewire remained stuck inside the catheter. The entire catheter, including the guidewire, had to be removed. Upon removal, a visible kink was observed in the tip of the catheter, making it impossible to remove the guidewire. The procedure was completed using a 2nd kit. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941803 ↗
• MalfunctionFeb 25, 2026Material Deformation

  IT WAS REPORTED THAT ONCE INSERTED, THE GUIDEWIRE IS COILING. WE OPENED THREE CATHETER FOR ONE PATIENT, BUT ALL HAD THE SAME PROBLEM OF GUIDEWIRE COILING. NO HARM WAS FOR THE PATIENT OR HCP, IT IS JUST A DELAY OF TREATMENT. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446634 ↗
• MalfunctionOct 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CLIENT INDICATES THAT THE RED LUER EXTENSION IS ANGLED. THEY BELIEVE THAT THE CLAMP IN THE BLISTER WAS CLOSED AND CAUSED THE CATHETER TO BE PINCHED. THE CATHETER IS REMOVED AND REPLACED WITH AN EQUIVALENT ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426684 ↗
• MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "RUPTURED CATHETER AT THE JUNCTION OF THE TRANSPARENT PART OF THE CATHETER AND THE DIVIDING PART. SMALL BUBBLES FOUND IN DIALYSIS SET DURING THE TREATMENT, RUPTURED CATHETER IDENTIFIED. THE CATHETER WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN ON (B)(6) 2024. RUPTURED CATHETER IDENTIFIED ON (B)(6) 2024. THE INCIDENT OCCURRED 9.5 HOURS AFTER THE START OF THE TREATMENT. THE TREATMENT WAS IMMEDIATELY DISCONTINUED, CATHETER WAS TAKEN OUT AND ANTIBIOTICS WERE GIVEN TO THE PATIENT. PATIENT RECOVERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713229 ↗
• MalfunctionDec 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE ICU PHYSICIANS ARE COMPLAINING OF THE BAD QUALITY OF POWER TRIALYSIS SHORT TERM STRAIGHT DIALYSIS CATHETER. THE GUIDE WIRE IS TWISTING DURING INSERTION AND IT ALSO STUCK TO THE VEIN AND THE PHYSICIAN HAD TO REMOVE BOTH THE WIRE AND THE CATHETER FOR PATIENT SAFETY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924726 ↗