RELIANCE XK Long-Term Hemodialysis Catheter 5323420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741012037), received between Jan 4, 2018 and Jan 11, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CATHETER WAS REMOVED AT AN OUTPATIENT DIALYSIS SETTING DUE TO AN INFECTION. THE FACILITY DOES NOT BELIEVE THE INFECTION HAD TO DO WITH THE CATHETER.

  Patient problems: Unspecified Infection

  MAUDE report 7183095 ↗
• MalfunctionJan 4, 2018Kinked; Material Integrity Problem; Material Twisted/Bent

  A REGISTER NURSE AT THE FACILITY REPORTED TO THE SALES REP THAT THE PLASTIC EXTENSION TUBING OF THE RELIANCE XK CATHETER TWISTED AND KINKED. IT WAS STATED THAT AN UNUSUALLY HIGH RATE WAS NOTED WHEN DIALYZING THROUGH THE CATHETER. THE REGISTER NURSE EXPRESSED IT SEEMS AS THOUGH THE TUBING IS MUCH THINNER THAN WHAT THE STAFF HAS PREVIOUSLY NOTICED WITH THE SAME CATHETERS. THERE HAVE NOT BEEN AN CHANGES TO THE CATHETER MAINTENANCE, CLEANSING OR CATHETER LOCKING PROCEDURES. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7164014 ↗