HemoStar Long-Term Hemodialysis Catheter 5834150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741013423), received between Mar 13, 2018 and Feb 3, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT A DIALYSIS CATHETER PLACEMENT PROCEDURE OCCURRED ON (B)(6) 2024, AND SOMETIME POST PROCEDURE, THE EXTERNAL LUMEN OF THE CATHETER ALLEGEDLY DEVELOPED A SMALL PINHOLE AND WAS EXPLANTED ON (B)(6) 2024. FOLLOW UP DETAILS PROVIDED BY THE COMPLAINANT ON (B)(6) 2024 INDICATED THAT THE PATIENT WAS UNKNOWN GENDER, 82 Y/O. THE LINE WAS REPLACED, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITH NO OTHER INTERVENTIONS REQUIRED FOR THIS INCIDENT. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291823 ↗
• MalfunctionJan 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE MONTH AND TWENTY-ONE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE EXTERNAL LUMEN OF THE CATHETER ALLEGEDLY DEVELOPED A SMALL PINHOLE. REPORTEDLY, THE CATHETER WAS REPLACED, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITH NO OTHER INTERVENTIONS REQUIRED FOR THIS INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093463 ↗
• MalfunctionJul 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CUFF OF THE CATHETER WAS ALLEGEDLY FAILED TO BOND. IT WAS FURTHER THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101127 ↗
• MalfunctionApr 21, 2022Backflow; Difficult to Flush; Suction Problem; Backflow; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT TWO DAYS POST DIALYSIS CATHETER IMPLANT, THE CATHETER ALLEGEDLY RUN IN THE REVERSE POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165753 ↗
• MalfunctionMar 22, 2022Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT ONE DAY POST DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY RUNNING IN THE REVERSE POSITION SINCE THE FIRST DIALYSIS AND WAS UNABLE TO BE RUN IN A STRAIGHT POSITION RESULTING IN POOR PATIENT CLEARANCE DUE TO HIGH RECIRCULATION. THE DEVICE WAS REPORTED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13854462 ↗
• MalfunctionJun 17, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015273 ↗
• MalfunctionMar 13, 2018Product Quality Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE RUBBER MATERIAL USED IN THE4 HEMOSTAR CVC ON THE TWO PORTS OUTSIDE THE PATIENT'S BODY ALLEGEDLY HAS MEMORY FROM THE CLAMPS, MEANING WHEN THE CLAMPS WERE APPLIED BETWEEN DIALYSIS, USUALLY TWO DAYS BETWEEN, THE RUBBER MATERIALS KEEP THE MEMORY OF THE CLAMP AND DO NOT GO BACK TO ITS ORIGINAL ROUND SHAPE WHEN UNCLAMPED , IT REMAINS COLLAPSED, FLAT AND NARROW. THIS APPARENTLY CAUSES REDUCTION AND RESTRICTION IN BLOOD FLOW THROUGH THE PORTS OF THE CVC, IN TURN CAUSES REDUCTION IN PUMP SPEED USED IN DIALYSIS, RESULTING IN REDUCTION IN CLEARANCE IN THE DIALYSIS TREATMENT OF THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7335831 ↗