HemoStar XK Long-Term Hemodialysis Catheter 5883690Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741013584), received between Jul 31, 2019 and Jun 1, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037397 ↗
• MalfunctionMay 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST THE DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017964 ↗
• InjuryMay 28, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWO DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING WHICH DID NOT STOP, AND THE TUBING WAS LATER CLAMPED WITH HEMOSTATS WHICH SUCCESSFULLY STOPPED THE BLEEDING. REPORTEDLY, THE CATHETER WAS REPLACED IN THE INTERVENTIONAL RADIOLOGY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016099 ↗
• MalfunctionJul 31, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING THE DIALYSIS CATHETER KIT, THE GUIDEWIRE WAS ALLEGEDLY MISSING. REPORTEDLY, ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8846603 ↗