HemoStar Long-Term Hemodialysis Catheter 5834190Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741013430), received between Mar 13, 2018 and Feb 20, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Collapse” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Restricted Flow rate; Reflux within Device; Suction Problem; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HEMOSTAR HEMODIALYSIS CATHETER. IT WAS REPORTED THAT THE CATHETER WAS SLIGHTLY FLATTENED. IT WAS FURTHER REPORTED THAT IT WAS RUN IN REVERSE WITH POWER FLUSHES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398569 ↗
• MalfunctionFeb 3, 2025Material Puncture/Hole; 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 21292458 ↗
• MalfunctionJun 27, 2024Collapse; Restricted Flow rate; Difficult to Flush; Stretched; Suction Problem; Material Protrusion/Extrusion; Material Too Soft/Flexible; Collapse; Restricted Flow rate; Difficult to Flush; Stretched; Suction Problem; Material Protrusion/Extrusion; Material Too Soft/Flexible

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR, EIGHT MONTHS, AND NINE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE ARTERIAL LUMEN OF THE CATHETER WAS ALLEGEDLY COLLAPSED SEVERELY ON ASPIRATION AND ALLEGEDLY DISTENDED ON FLUSHING THE ARTERIAL LINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622925 ↗
• MalfunctionApr 26, 2022Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST DIALYSIS CATHETER IMPLANT, THE CATHETER ALLEGEDLY DIFFICULT TO FLUSH. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY HAD SUCTION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14203854 ↗
• MalfunctionNov 1, 2021Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY MIGRATED OUTWARDS WITH THE CUFF AND THE PROCEDURE WAS ABORTED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 12726080 ↗
• MalfunctionAug 26, 2021Collapse; Restricted Flow rate; Material Twisted/Bent; Collapse; Restricted Flow rate; Material Twisted/Bent

  IT WAS REPORTED THAT SOME TIME POST PROCEDURE, THE CATHETER WAS ALLEGEDLY TWISTED AND COLLAPSED WHILE ASPIRATING. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULT TO INCREASE PUMP SPEED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368943 ↗
• MalfunctionAug 18, 2021Collapse; Restricted Flow rate; Material Twisted/Bent; Collapse; Restricted Flow rate; Material Twisted/Bent

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE LINES WERE ALLEGEDLY REPORTED TO BE COLLAPSING UPON ASPIRATION. IT WAS FURTHER REPORTED THAT THE LINES WERE NOTED TO BE TWISTED AND WAS DIFFICULT TO INCREASE THE PUMP SPEED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335087 ↗
• InjuryAug 15, 2021Fluid/Blood Leak; Material Separation; Improper Flow or Infusion; Fluid/Blood Leak; Material Separation; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY SEPARATED AND HAD A FLUID LEAK, IMPROPER FLOW. IT WAS FURTHER REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12322325 ↗
• MalfunctionAug 13, 2021Defective Component; Failure to Infuse; Obstruction of Flow; Defective Component; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A DEFECTIVE COMPONENT, INFUSION PROBLEM AND OBSTRUCTION OF FLOW. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318463 ↗
• MalfunctionAug 13, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INFUSION PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317974 ↗
• MalfunctionAug 13, 2021Failure to Infuse; Deformation Due to Compressive Stress; Failure to Infuse; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DEFORMED AND HAD AN INFUSION PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317921 ↗
• MalfunctionAug 13, 2021Collapse; Material Twisted/Bent; Collapse; Material Twisted/Bent

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY COLLAPSED AND TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317562 ↗
• InjuryDec 29, 2020Fluid/Blood Leak; Material Separation; Failure to Infuse; Obstruction of Flow; Improper Flow or Infusion; Fluid/Blood Leak; Material Separation; Failure to Infuse; Obstruction of Flow; Improper Flow or Infusion

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE DEVICE ALLEGEDLY EXPERIENCED IMPROPER FLOW, INFUSION PROBLEM, MATERIAL SEPARATION AND LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085796 ↗
• MalfunctionDec 1, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER ARTERIAL PORT ALLEGEDLY COLLAPSES WHEN ASPIRATING FROM THE LINE AND VENOUS PORT IS SLIGHTLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926589 ↗
• MalfunctionNov 9, 2020Collapse; Collapse

  IT WAS REPORTED THAT DURING A HEMODIALYSIS CATHETER PLACEMENT PROCEDURE, THE VENOUS LINE WAS ALLEGEDLY COLLAPSED WHEN ASPIRATED FROM CVC CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10807545 ↗
• InjuryJul 8, 2020Fluid/Blood Leak; Free or Unrestricted Flow; Fluid/Blood Leak; Free or Unrestricted Flow

  IT WAS REPORTED THAT DURING A DIALYSIS PROCEDURE, THE PATIENT ALLEGEDLY HAD A LEAK FROM THE ARTERIAL LUMEN. REPORTEDLY THE LUMEN WAS IMMEDIATELY CLAMPED, AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10243586 ↗
• MalfunctionApr 17, 2018Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE RUBBER MATERIAL USED BY 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 SUPPOSEDLY 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 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. THE RUBBER /PLASTIC USED TO MAKE THE TWO PORTS SHOULD NOT KEEP THE MEMORY OF THE CLAMPS. FOR THIS PATIENT, MOST DIALYSIS RUNS IN THE LAST THREE MONTHS REQUIRED REVERSING THE TWO PORTS, RESULTING REDUCE CLEARANCE OF THOSE DIALYSIS RUNS.

  Patient problems: No Code Available

  MAUDE report 7438555 ↗
• MalfunctionMar 21, 2018Mechanics Altered

  IT WAS REPORTED THAT THE RUBBER MATERIAL USED BY HEMOSTAR CVC ON THE TWO PORTS OUTSIDE THE PATIENT'S BODY HAS MEMORY FROM THE CLAMPS. WHEN THE CLAMPS WERE APPLIED BETWEEN DIALYSIS TREATMENTS (USUALLY TWO DAYS) THE RUBBER MATERIAL ALLEGEDLY KEEPS THE MEMORY OF THE CLAMP AND DOES NOT GO BACK TO ITS ORIGINAL ROUND SHAPE WHEN UNCLAMPED. IT REMAINS COLLAPSED, FLAT AND NARROW. THIS 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. THE RUBBER/PLASTIC USED TO MAKE THE TWO PORTS SHOULD NOT KEEP THE MEMORY OF THE CLAMPS. FOR THIS PATIENT, THERE WERE MANY DIALYSIS RUNS THAT REQUIRED REVERSING THE TWO PORTS, RESULTING, REDUCES CLEARANCE OF THOSE DIALYSIS RUNS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358363 ↗
• MalfunctionMar 15, 2018Collapse

  IT WAS REPORTED THAT THE RUBBER MATERIAL USED BY 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, 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. USER BELIEVES THAT THE RUBBER /PLASTIC USED TO MAKE THE TWO PORTS SHOULD NOT KEEP THE MEMORY OF THE CLAMPS.

  Patient problems: No Code Available

  MAUDE report 7342829 ↗
• MalfunctionMar 13, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE RUBBER MATERIAL USED IN THE 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, WHICH 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 Known Impact Or Consequence To Patient

  MAUDE report 7335802 ↗