RELIANCE XK Long-Term Hemodialysis Catheter 5327190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741012099), received between Apr 18, 2017 and May 18, 2017 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2017Break

  IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE CLAMP BROKE WHEN THE PATIENT CAME IN FOR DIALYSIS, IT WAS THE ARTERIAL CLAMP. ON 5/11/17-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575202 ↗
• MalfunctionMay 18, 2017Break

  IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE CLAMP BROKE WHEN THE PATIENT CAME IN FOR DIALYSIS, IT WAS THE VENOUS CLAMP. ON 5/11/2017-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575147 ↗
• MalfunctionMay 18, 2017Break

  ON (B)(6) 2017 - IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE CLAMP BROKE WHEN THE PATIENT CAME IN FOR DIALYSIS, IT WAS THE ARTERIAL CLAMP. ON (B)(6) 2017-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575146 ↗
• MalfunctionMay 18, 2017Break

  IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE CLAMP BROKE WHEN THE PATIENT CAME IN FOR DIALYSIS, IT WAS THE ARTERIAL CLAMP. ON (B)(6) 2017-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575144 ↗
• MalfunctionMay 18, 2017Break

  IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE CLAMP BROKE WHEN THE PATIENT CAME IN FOR DIALYSIS, IT WAS THE VENOUS CLAMP. ON (B)(6) 2017-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575142 ↗
• MalfunctionMay 15, 2017Break

  FACILITY REPORTED TO THE SALES REP THAT THE CLAMP IS BROKE ON THE CATHETER DURING THE PROCEDURE. DEVICE WAS REMOVED AND ANOTHER DEVICE USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM WAS REPORTED. ON 4/25/2017 - ADDITIONAL INFORMATION REPORTED BY THE SALES REP, THAT THE CLAMP IS BREAKING DURING DIALYSIS AS SOON AS THE NURSE IS PUTTING PRESSURE ON THE CLAMP; CAUSING THE CLAMP TO FALL APART. THE SALES REP IS NOT SURE IF THIS IS WHEN THE NURSE IS CLAMPING OR UNCLAMPING THE DEVICE. ON 5/11/2017-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567947 ↗
• MalfunctionApr 18, 2017Detachment Of Device Component; Component Falling

  IT WAS REPORTED BY THE FACILITY VIA CUSTOMER SERVICE THAT THE CATHETER FELL OUT AFTER THE SUTURES WERE REMOVED, THE SUTURES ARE REMOVED AFTER A TWO WEEK PERIOD BASED ON THE CUSTOMER'S FACILITY POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6501523 ↗