RELIANCE XK Long-Term Hemodialysis Catheter 5323190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741011986), received between Feb 17, 2017 and Feb 19, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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.

• MalfunctionFeb 19, 2025Difficult to Flush; Suction Problem; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Flush; Suction Problem; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE WIRE WAS DIFFICULT TO THREAD THROUGH THE ARTERIAL PORT OF THE CATHETER. IT WAS FURTHER REPORTED THAT TRIED TO ASPIRATE THROUGH THE PORT, THERE WAS RESISTANCE FELT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408563 ↗
• MalfunctionAug 24, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN, THE DEVICE ALLEGEDLY HAD A LOW FLOW RATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283563 ↗
• MalfunctionApr 27, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TUNNELER ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219191 ↗
• InjuryJul 15, 2021Fluid/Blood Leak; Fracture; Air/Gas in Device; Fluid/Blood Leak; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE AIR GUARD WAS ALLEGEDLY LEAKED AND BOLUS OF AIR ENTERED INTO THE PATIENT. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 12171496 ↗
• MalfunctionFeb 17, 2017Entrapment of Device; Material Fragmentation

  FACILITY REPORTED TO THE SALES REP THAT PART OF THE PEEL AWAY SHEATH BROKE APART AND LEFT LITTLE SHARDS OF PLASTIC ON THE CATHETER DURING INSERTION. THE HEALTHCARE PROFESSIONAL HAD TO "PICK THEM OUT OF THE TRACT INTO THE VEIN". NO OTHER INFORMATION WAS PROVIDED OR PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6341340 ↗