RELIANCE XK Alphacurve Long-Term Hemodialysis Catheter 5325190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741012051), received between Oct 12, 2017 and Dec 19, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionDec 19, 2017Kinked

  IT WAS REPORTED THAT DURING PLACEMENT "INSERTION OF DENOVO TUNNELED CENTRAL VENOUS CATHETER FOR DIALYSIS. PHYSICIAN NOTED THAT THE J PORTION OF THE J WIRE WAS NOT SMOOTH AND THE SCRUB TECH SHOWED THE PHYSICIAN THE SPLIT IN THE PEEL AWAY DILATOR. THE KIT WAS ABANDONED AND A NEW KIT WAS OPENED". ON (B)(6) 2017-EVALUATION FOUND KINKED GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131570 ↗
• MalfunctionOct 12, 2017Defective Component

  IT WAS REPORTED BY THE FACILITY THAT DURING PLACEMENT "INSERTION OF DENOVO TUNNELED CENTRAL VENOUS CATHETER FOR DIALYSIS. THE GUIDEWIRE AND THE PEEL AWAY SHEATH WERE DEFECTIVE IN THE KIT. ANOTHER KIT WAS USED FOR THE PROCEDURE. THE REPORTED EVENT RESULTED IN USE OF A NEW KIT, CAUSING AN INCONSEQUENTIAL PROLONGATION OF THE PROCEDURE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945852 ↗