HemoStar Long-Term Hemodialysis Catheter 5833730Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 00801741013409), received between Oct 7, 2016 and Jun 4, 2026 — classified as 1 death, 9 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 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 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• DeathJun 4, 2026Fluid/Blood Leak; Fracture

  ON (B)(6) 2024, A PATIENT UNDERWENT CATHETERIZATION INTO THE RIGHT INTERNAL JUGULAR VEIN USING THE HEMOSTAR HEMODIALYSIS CATHETER. ON (B)(6) 2024, THE PATIENT EXPERIENCED A RUPTURE OF THE DIALYSIS CATHETER WHILE AT HOME. EMERGENCY RESPONDERS APPLIED PRESSURE TO THE TUBING AND TRANSFERRED THE PATIENT TO THE HOSPITAL AND DIAGNOSED WITH ACUTE RESPIRATORY FAILURE AND HEMORRHAGIC SHOCK. THE PATIENT WENT INTO CARDIAC ARREST AND CPR WAS PERFORMED. DESPITE RESUSCITATION EFFORTS, THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiac Arrest; Hypovolemic Shock

  MAUDE report 25390370 ↗
• MalfunctionApr 6, 2026Restricted Flow rate; Suction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT-SIDED SEMI-PERMANENT HEMODIALYSIS CATHETER PLACEMENT USING HEMOSTAR HEMODIALYSIS CATHETER TO REPLACE A DEFECTIVE CATHETER. POST THE PROCEDURE ON (B)(6) 2026, POOR BLOOD WITHDRAWAL WAS NOTED FROM THE RED END OF THE CATHETER, LEADING TO INADEQUATE HEMODIALYSIS. IT WAS FURTHER REPORTED THAT BLOOD FLOW WAS INADEQUATE. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787411 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak; Suction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT A SEMI PERMANENT DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN USING HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT BLOOD COULD NOT BE WITHDRAWN AND FURTHER REPORTED THAT BLOOD WAS LEAKED FORM THE TIP OF THE PUNCTURE NEEDLE. THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765977 ↗
• MalfunctionApr 2, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR DEVICE. PRIOR TO THE PROCEDURE, DURING PREPARATION AND WHILE THE PACKAGING REMAINED UNOPENED, AN UNKNOWN LIQUID WAS OBSERVED INSIDE THE CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762518 ↗
• MalfunctionMar 31, 2026Restricted Flow rate; Suction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT SIDED SEMI PERMANENT HEMODIALYSIS CATHETER PLACEMENT USING HEMOSTAR HEMODIALYSIS CATHETER TO REPLACE DEFECTIVE CATHETER. ON (B)(6) 2026, SOMETIMES POST DIALYSIS CATHETER PLACEMENT PROCEDURE, POOR BLOOD WITHDRAWAL WAS NOTED FROM THE RED END OF THE CATHETER, LEADING TO INADEQUATE HEMODIALYSIS. IT WAS FURTHER REPORTED THAT BLOOD FLOW WAS INADEQUATE. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740351 ↗
• MalfunctionMar 30, 2026Restricted Flow rate

  ON (B)(6) 2026, A PATIENT WITH CHRONIC KIDNEY DISEASE STAGE 5 UNDERWENT A HEMODIALYSIS TREATMENT USING THE HEMOSTAR. DURING THE PROCEDURE INADEQUATE CATHETER BLOOD FLOW WAS OBSERVED. THE CATHETER WAS TREATED WITH UROKINASE. HOWEVER, THE VENOUS PRESSURE REMAINED HIGH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711853 ↗
• MalfunctionMar 18, 2026Difficult to Flush; Fracture; Suction Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR HEMODIALYSIS CATHETER. DURING FLUSHING, IT WAS NOTED THAT THE INTRODUCER NEEDLE HAD BROKEN, WHICH PREVENTED FLUID FROM BEING EXTRACTED. IT WAS FURTHER REPORTED THAT THE INTRODUCER NEEDLE COULD NOT BE FLUSHED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625519 ↗
• MalfunctionFeb 23, 2026Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR. DURING THE PROCEDURE, THE DEVICE COULD NOT BE ADVANCED INTO THE PATIENT BECAUSE IT WAS KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411422 ↗
• MalfunctionJan 12, 2026Stretched; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR. DURING THE PROCEDURE IT WAS REPORTED THAT THE DEVICE ALLEGEDLY GOT MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033586 ↗
• MalfunctionDec 1, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR. PRIOR TO PROCEDURE, IT WAS REPORTED THAT FINDING THREE PUNCH HOLES WERE FOUND ON TWO OF THEIR HEMOSTAT DIALYSIS CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678822 ↗
• MalfunctionOct 7, 2025Fracture; Material Separation; Stretched; Unraveled Material; Fracture; Material Separation; Stretched; Unraveled Material

  ON (B)(6) 2025, THE PATIENT UNDERWENT A SEMI-PERMANENT VENOUS CATHETERIZATION FOR RENAL DIALYSIS UNDER ULTRASOUND GUIDANCE IN THE OPERATING ROOM. THE PATIENT WAS POSITIONED SUPINE WITH THE HEAD TURNED TO THE LEFT. FOLLOWING ROUTINE PREOPERATIVE DISINFECTION AND DRAPING, LOCAL ANESTHESIA WITH LIDOCAINE WAS ADMINISTERED. A PUNCTURE NEEDLE WAS INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN, FOLLOWED BY PLACEMENT OF A GUIDEWIRE. AFTER LOCALIZATION UNDER LOCAL ANESTHESIA AND CREATION OF A SUBCUTANEOUS TUNNEL, THE SKIN WAS DILATED ALONG THE GUIDEWIRE AND A DILATOR INSERTED. ONCE THE VESSEL WAS DILATED, THE GUIDEWIRE WAS ADVANCED THROUGH THE LONG-TERM CATHETER AND WITHDRAWN FROM THE VENOUS END. DURING GUIDEWIRE EXTRACTION, LAYERING OCCURRED, THE OUTERMOST COIL OF THE GUIDEWIRE DETACHED, EXPOSING THE CORE. SUBSEQUENTLY, BOTH THE LONG-TERM CATHETER AND GUIDEWIRE WERE REMOVED. A NEW PUNCTURE SITE WAS ESTABLISHED, AND A FRESH GUIDEWIRE WAS INSERTED. A SUBCUTANEOUS TUNNEL WAS CREATED, FOLLOWED BY PLACEMENT OF A TEAR-OFF SLEEVE ALONG THE GUIDEWIRE. THE LONG-TERM CATHETER WAS THEN INSERTED, AND THE TEAR-OFF SLEEVE WAS REMOVED. VASCULAR POSITIONING WAS ADJUSTED UNTIL BLOOD FLOW WAS ESTABLISHED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23232378 ↗
• MalfunctionSep 25, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A DIALYSIS PLACEMENT PROCEDURE USING HOMESTAR. DURING THE IMPLANTATION OF A HEMOSTAR HEMODIALYSIS CATHETER, FRACTURE AND FLUID LEAKAGE WAS OBSERVED BETWEEN THE RED LUER-LOCK CONNECTOR AND THE SYRINGE AND THERE WAS NO COMPLETE RUPTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143297 ↗
• InjuryAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR. DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE KIT CONNECTOR WAS ALLEGEDLY FELL OFF IN THE SUBCUTANEOUS TUNNEL AND THE CURVED PLIERS FROM THE SUBCUTANEOUS TUNNEL STRIPPING CLIP OUT. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22791200 ↗
• MalfunctionJul 31, 2025Material Opacification; Deformation Due to Compressive Stress; Material Opacification; Deformation Due to Compressive Stress

  ON (B)(6), A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE. ON (B)(6) 2025, THE CATHETER WAS ALLEGEDLY FOUND EMULSIFIED AND ALLEGEDLY GOT BENT. THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677994 ↗
• MalfunctionJul 28, 2025Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  ON (B)(6) 2025, A 71-YEAR-OLD MALE PATIENT WAS UNDERGOING A DIALYSIS CATHETER PLACEMENT USING HEMOSTAR. DURING THE PROCEDURE, THE INTRODUCER THE NEEDLE WAS ALLEGEDLY FOUND AIR LEAK. IT WAS FURTHER REPORTED THAT NEEDLE WAS ALLEGEDLY FOUND THAT IT CANNOT BE SUCTION LIQUID. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628497 ↗
• MalfunctionJul 1, 2025Suction Problem; Defective Component; Suction Problem; Defective Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR AND IT WAS REPORTED THAT DURING PROCEDURE, THE CATHETER IS TOO LONG, SO NEEDED TO CUT THE TIP ABOUT 0.8CM, AFTER THE PLACEMENT THEN ALSO BACK TO DRAW THE BLOOD FLOW IS NOT GOOD, AFTER SEVERAL TIMES DEBUGGING AND MAKING VENOUS END SMOOTHENED, THEN ALSO THE ARTERIAL END WAS SLIGHTLY BLOCKED. CHEST X-RAY WAS TAKEN WHERE THE CATHETER WAS FIXED, AND THE JUGULAR ULTRASOUND ON THE FOLLOWING DAY SHOWED NO ABNORMALITY, AND NO ABNORMALITY OF THE CATHETER'S POSITION WAS FOUND IN THE AREA THAT WAS EXAMINED. THE CATHETER FLOW IS CURRENTLY GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369082 ↗
• MalfunctionMay 19, 2025Restricted Flow rate; Suction Problem; Obstruction of Flow; Restricted Flow rate; Suction Problem; Obstruction of Flow

  ON (B)(6) 2024, A PATIENT UNDERWENT A DIALYSIS CATHETER BECAUSE OF CHRONIC RENAL FAILURE, NEED TO ESTABLISH LONG TERM HEMODIALYSIS ACCESS. THE DIALYSIS CATHETER FOR THE PATIENT TO DO THE RIGHT JUGULAR VEIN CANNULATION. AFTER PLACEMENT OF THE PATIENT'S DIALYSIS CATHETER FLOW IS POOR, AND SINCE THEN REPEATED SIMILAR SITUATIONS, AFTER MANY ADJUSTMENTS TO THE PIPE, THROMBOLYSIS AND OTHER OPERATIONS CAN BE IMPROVED. ON (B)(6) 2025, THE PATIENT'S CATHETER WAS BLOCKED AGAIN, AFTER UROKINASE PUMPED INTO THE THROMBOLYTIC TREATMENT IMPROVED, BUT THE FLOW REMAINED SUBOPTIMAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042352 ↗
• MalfunctionMay 19, 2025Restricted Flow rate; Suction Problem; Obstruction of Flow; Restricted Flow rate; Suction Problem; Obstruction of Flow

  ON (B)(6) 2024, A PATIENT UNDERWENT A DIALYSIS CATHETAR BECAUSE OF CHRONIC RENAL FAILURE, NEED TO ESTABLISH LONG TERM HEMODIALYSIS ACCESS. THE DIALYSIS CATHETER FOR THE PATIENT TO DO THE RIGHT JUGULAR VEIN CANNULATION. AFTER PLACEMENT OF THE PATIENT'S DIALYSIS CATHETER FLOW WAS POOR, AND SINCE THEN REPEATED SIMILAR SITUATIONS, AFTER MANY ADJUSTMENTS TO THE PIPE, THROMBOLYSIS AND OTHER OPERATIONS CAN BE IMPROVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 22042351 ↗
• MalfunctionMay 16, 2025Material Opacification; Deformation Due to Compressive Stress; Material Opacification; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT POST DIALYSIS CATHETER PLACEMENT, ALLEGEDLY EPITHELIAL CATHETER APPEARED TO BE HAD EMULSIFICATION PHENOMENON AND FURTHER CATHETER WAS FOUND DEFORMED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE CATHETER ALLEGEDLY APPEARED TO BE EMULSIFICATION PHENOMENON AND DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036420 ↗
• MalfunctionMay 16, 2025Material Opacification; Material Opacification

  IT WAS REPORTED THAT POST DIALYSIS CATHETER PLACEMENT, ALLEGEDLY EPITHELIAL CATHETER APPEARED TO BE HAD EMULSIFICATION PHENOMENON AND FURTHER CATHETER WAS FOUND DEFORMED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE CATHETER ALLEGEDLY APPEARED TO BE EMULSIFICATION PHENOMENON AND DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036415 ↗
• InjuryMay 14, 2025Fracture; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Fracture; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  ON (B)(6) 2025, A PATIENT UNDERWENT LONG-TERM DIALYSIS WITH A TUNNELED POLYESTER CANNULA VIA THE RIGHT INTERNAL JUGULAR VEIN. DURING THE PROCEDURE THE GUIDEWIRE WAS ALLEGEDLY FOUND RESISTANCE DURING THE INSERTION OF THE INTRODUCER NEEDLE AND GUIDE WIRE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE COULD NOT BE REMOVED SMOOTHLY AND WAS FRACTURED. REPORTEDLY, PATIENT ALLEGEDLY EXPERIENCED BLEEDING. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22017841 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2024, A PATIENT UNDERWENT A DIALYSIS CATHETER PROCEDURE USING THE HEMOSTAR DIALYSIS CATHETER. DURING PREPARATION, THE CATHETER EXTENSION TUBE ALLEGEDLY LEAKED. ADDITIONALLY, IT WAS REPORTED THAT THE CATHETER HAD A CRACK. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959043 ↗
• MalfunctionApr 16, 2025Loss of or Failure to Bond; Restricted Flow rate; Expulsion; Loss of or Failure to Bond; Restricted Flow rate; Expulsion

  IT WAS REPORTED THAT DURING HEMODIALYSIS, THE DIALYSIS CATHETER HAD SLIPPED OUT OF PLACE. IT WAS ALSO REPORTED THAT BLOOD FLOW BECOME IRREGULAR AND MAKING IT IMPOSSIBLE TO CONTINUE HEMODIALYSIS TREATMENT WITH THE CATHETER. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO HAVE THE CATHETER REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847776 ↗
• MalfunctionApr 8, 2025Stretched; Deformation Due to Compressive Stress; Material Protrusion/Extrusion; Stretched; Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT FIVE MONTHS AND TWELVE DAYS POST CATHETER PLACEMENT PROCEDURE, THE ARTERIAL END OF THE SEMI-PERMANENT TUBE WAS FOUND TO BE ABNORMALLY BULGING. CATHETER WAS REMOVED AND REPLACED DUE TO THE RISK OF FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21795919 ↗
• InjuryFeb 24, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE PEEL AWAY SHEATH WAS ALLEGEDLY SO TOUGH TO BE UNWRAPPED. IT WAS FURTHER REPORTED THAT WHEN IT WAS UNWRAPPED, IT ALLEGEDLY CAUSED AN INTERNAL JUGULAR VEIN INJURY TO THE PATIENT. REPORTEDLY, AN OPERATION WAS PERFORMED TO FIX THE INTERNAL JUGULAR VEIN INJURY. THE PATIENT STATUS IS REPORTED TO BE STABLE NOW.

  Patient problems: Perforation of Vessels

  MAUDE report 21454711 ↗