HemoStar XK Long-Term Hemodialysis Catheter 5883730Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741013607), received between Jul 19, 2016 and Nov 10, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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.

• MalfunctionNov 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT SEVEN DAYS POST DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TUBING WAS ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769002 ↗
• MalfunctionAug 26, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE INTRODUCER WAS ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299864 ↗
• MalfunctionApr 13, 2021Fracture; Difficult to Insert; Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Difficult to Insert; Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT, THE GUIDEWIRE ALLEGEDLY FAILED TO INSERT THROUGH THE INTRODUCER NEEDLE AND FAILED TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656035 ↗
• MalfunctionAug 6, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373324 ↗
• MalfunctionJun 11, 2018Kinked; Material Deformation; Kinked; Material Deformation

  IT WAS REPORTED THAT A DIALYSIS CATHETER HAD ALLEGEDLY KINKED AND WOULD NOT ALLOW FLOW. THERE WERE NO OTHER COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589880 ↗
• MalfunctionJun 4, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT A DIALYSIS KIT HAD A WIRE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566368 ↗
• MalfunctionJul 19, 2016Hole In Material; Failure to Advance

  ON (B)(6) 2016 - IT WAS REPORTED BY COMPLAINANT THAT DURING THE PROCEDURE THE DIALYSIS DEVICE "DID NOT WORK". CONTACT STATED THAT THERE WAS A HOLE IN THE CATHETER. ON (B)(6) 2016 - DESPITE MULTIPLE ATTEMPTS DURING PLACEMENT, THE DIALYSIS CATHETER COULD NOT BE ADVANCED OVER THE WIRE AND FACILITY REPORTED THAT ACCESS WAS LOST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5806839 ↗