HemoStar Long-Term Hemodialysis Catheter 5835230Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741013508), received between Aug 12, 2020 and Feb 10, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• MalfunctionFeb 10, 2026Material Integrity Problem

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301269 ↗
• MalfunctionNov 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY MISSING LOT NUMBER, MATERIAL NUMBER AND THE EXPIRATION DATE DETAILS ON ONE OF THE ITEMS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793923 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fracture; Air/Gas in Device; Fluid/Blood Leak; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT NINE MONTHS AND THIRTEEN DAYS POST A DIALYSIS CATHETER PLACEMENT, THERE WAS A TEAR IN THE ARTERIAL PART OF THE CATHETER JUST AT THE DISTAL EXIT OF THE HUB. IT WAS FURTHER REPORTED THAT THE TEAR ALSO CAUSED SOME AIR TO BE DRAWN INTO THE CATHETER. FURTHERMORE, IT WAS FOUND THAT THERE WAS ALLEGEDLY A LEAK. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381492 ↗
• MalfunctionAug 12, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO THE CATHETER PLACEMENT, OUT OF FIVE DEVICES TWO DEVICES WERE ALLEGEDLY MISSING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10394673 ↗