Power-Trialysis Alphacurve catheter 5655200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741066078), received between Mar 25, 2022 and Apr 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 10, 2026Open, Classified

   this is a downstream recall of class I recall RES 98777

   Z-2984-2026 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THE CATHETER WAS NOT THE SIZE THAT THE PACKAGE STATED. THE CATHETER WAS 24CM AND THE PACKAGING STATES 20CM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978080 ↗
• MalfunctionMar 25, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE HAD A COMPLAINT FROM A PHYSICIAN ABOUT THE SIZE OF THE CATHETER NOT BEING WHAT THE PACKAGE SAID IT WAS. IT WAS BROUGHT TO MY ATTENTION YESTERDAY THAT THE CATHETER IN THIS KIT WAS A 24CM CATHETER AND THE PACKAGING STATES THE CATHETER IS 20CM. HE PLACED THE LINE IN FACILITY. THIS PRESENTS A CHALLENGE IN PLACING THE LINE AND IN SECURING THE LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908781 ↗