HemoStar Long-Term Hemodialysis Catheter 5833150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741013317), received between Nov 22, 2017 and Dec 20, 2019 — classified as 4 malfunctions.

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

• MalfunctionDec 20, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE DIALYSIS CATHETER BROCHURE HAD AN ALLEGED ERROR AS THE PICTURE SHOWED SIDEHOLES IN ONE TYPE OF DIALYSIS CATHETER BUT INFORMATION DETAILS SHOWED ANOTHER DIALYSIS CATHETER INCLUDES THREE HUNDRED SIXTY DEGREE MULTIPLE SIDHOLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9507484 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TESTING OF THE DIALYSIS CATHETER, AN ALLEGED LEAK WAS FOUND. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8528123 ↗
• MalfunctionDec 21, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THE GUIDE WIRE WAS STUCK IN THE INTRODUCTION NEEDLE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189336 ↗
• MalfunctionNov 22, 2017Crack

  IT WAS REPORTED THAT THE CATHETER WAS INSERTED APPROXIMATELY THREE WEEKS AGO. TODAY AS THE NURSE WAS PREPARING TO DIALYZE THE PATIENT SHE NOTICED THAT THE CATHETER HAD CRACKED AT THE CLAMPING SITE OF THE ARTERIAL LUMEN. THE PATIENT NEEDS TO UNDERGO CATHETER REMOVAL AND REINSERTION PROCEDURES. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053943 ↗