HemoStar Long-Term Hemodialysis Catheter 5833690Recalls & reported problems

Summary

The FDA's MAUDE database contains 290 adverse event reports that list this exact device (DI 00801741013386), received between Jan 21, 2016 and Sep 29, 2026 — classified as 2 deaths, 24 injuries, 264 malfunctions.

The most frequently reported specific device problem is “Fracture” (81 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 290 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  On (b)(6) 2026, a patient was prepared for a dialysis catheter placement procedure using a HemoStar Hemodialysis Catheter. Prior to patient use, during device preparation, the physician inspected the product's outer packaging and observed no abnormalities. After opening the catheter package and flushing the introducer needle and catheter with saline, fluid leakage was observed from the introducer needle. The device was not used on the patient, and the procedure was subsequently completed using another device. There was no reported patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928109 ↗
• MalfunctionJun 4, 2026Material Opacification

  ON (B)(6) 2025, A PATIENT UNDERWENT DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR HEMODIALYSIS CATHETER. AFTER SOME TIME, ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER CONNECTING SEGMENT APPEARED TO BE SEVERELY EMULSIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25388471 ↗
• MalfunctionMay 25, 2026Suction Problem; Air/Gas in Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, AIR ALLEGEDLY LEAKED IN THE SYRINGE NEEDLE AND BLOOD COULD NOT BE WITHDRAWN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25269301 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak; Fracture; Air/Gas in Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER IMPLANTATION USING HEMOSTAR HEMODIALYSIS CATHETER. DURING PROCEDURE FOR A PATIENT WITH CHRONIC RENAL FAILURE IN THE UREMIC STAGE, THE CATHETER KIT WAS INSPECTED PREOPERATIVELY AND CONFIRMED TO BE WITHIN ITS VALIDITY PERIOD. PUNCTURE OF THE INTERNAL JUGULAR VEIN WAS SUCCESSFUL WITH FLUENT VENOUS BLOOD RETURN. HOWEVER, A LARGE NUMBER OF AIR BUBBLES WERE OBSERVED DURING ASPIRATION. TROUBLESHOOTING MEASURES, INCLUDING REPLACEMENT OF OTHER CONSUMABLES SUCH AS SYRINGES, DID NOT RESOLVE THE ISSUE, AND THE SOURCE OF THE AIR BUBBLES WAS ATTRIBUTED TO THE CATHETER KIT, PROMPTING IMMEDIATE DISCONTINUATION OF ITS USE. THE CATHETER TUBING WAS REPLACED WITH A NEW ONE, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT ANY KNOWN PATIENT HARM. POSTOPERATIVELY, LEAKAGE WAS NOTED FROM THE PLASTIC COMPONENT WHEN THE INTRODUCER NEEDLE EYE'S FURTHER INSPECTION REVEALED AN IMPERCEPTIBLE CRACK IN THE INTRODUCER NEEDLE, CONFIRMING IT AS THE CAUSE OF THE INTRAOPERATIVE AIR BUBBLES. THE DAMAGED INTRODUCER NEEDLE WAS SUBSEQUENTLY SEALED AND LABELED AS "DAMAGED" IN ACCORDANCE WITH MEDICAL WASTE CLASSIFICATION REQUIREMENTS. THERE WAS NO REPORTED PATIENT INJUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179902 ↗
• MalfunctionMay 12, 2026Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A RIGHT INTERNAL JUGULAR VEIN LONG TERM HEMODIALYSIS CATHETER PLACEMENT USING THE HEMOSTAR. PRE OPERATIVE INSPECTION CONFIRMED THE DIALYSIS CATHETER PACKAGE WAS INTACT AND WITHIN EXPIRATION. DURING THE PROCEDURE, VENOUS PUNCTURE WAS SUCCESSFULLY PERFORMED WITH SMOOTH BLOOD RETURN HOWEVER, AFTER PLACEMENT, THE GUIDEWIRE COULD NOT BE ADVANCED INTO THE VESSEL, AND SLIGHT DEFORMATION OF THE GUIDEWIRE WAS OBSERVED UPON WITHDRAWAL. A SECOND PUNCTURE ATTEMPT WAS MADE, BUT THE GUIDEWIRE AGAIN COULD NOT BE INSERTED. THE CENTRAL VENOUS CATHETER KIT WAS THEN REPLACED, AFTER WHICH THE GUIDEWIRE WAS SUCCESSFULLY ADVANCED AND THE PROCEDURE COMPLETED. THE INCIDENT RESULTED IN ADDITIONAL PAIN DURING CATHETER PLACEMENT AND INCREASED THE POTENTIAL RISK OF BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 25145964 ↗
• MalfunctionMay 6, 2026Fluid/Blood Leak

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN. DURING THE PROCEDURE, THE INTRODUCER NEEDLE ALLEGEDLY LEAKED BLOOD. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090528 ↗
• MalfunctionApr 21, 2026Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A HAIR WAS FOUND INSIDE THE CATHETER DURING THE OPERATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934592 ↗
• MalfunctionApr 6, 2026Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PLACEMENT PROCEDURE FOR INSERTION OF A LONG TERM HEMODIALYSIS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN USING THE HEMOSTAR. THE PATIENT HAD A CONFIRMED DIAGNOSIS OF STAGE 5 CHRONIC KIDNEY DISEASE AND WAS TAKEN TO THE OPERATING ROOM FOR THE PROCEDURE. THE CATHETER PLACEMENT WAS INITIATED UNDER GUIDEWIRE GUIDANCE. DURING INSERTION, THE CATHETER WAS ADVANCED INTO THE TEAR OFF SHEATH AND DILATOR ASSEMBLY. HOWEVER, IT WAS NOTED THAT THE CATHETER WAS NOT ADVANCING PROPERLY, AND THE TIP OF THE DILATOR WAS OBSERVED TO BE SLIGHTLY BENT AND DEFORMED. THE ANGLE WAS ADJUSTED, AND THE DILATOR WAS REINTRODUCED. UPON WITHDRAWAL OF THE GUIDEWIRE, THE GUIDEWIRE WAS ALSO FOUND TO BE BENT AND DEFORMED. DESPITE THESE ISSUES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT RESULTED IN INCREASED PAIN DURING CATHETER PLACEMENT AND AN INCREASED RISK OF BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 24788071 ↗
• InjuryMar 25, 2026Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  ON (b)(6) 2026, A PATIENT UNDERWENT A TRANSVENOUS LONG TERM DIALYSIS CATHETER IMPLANTATION PROCEDURE USING HEMOSTAR. DURING THE PROCEDURE, IT WAS NOTED THAT DUE TO KINKING OF THE TEAR OFF SHEATH, NORMAL INSERTION WAS NOT POSSIBLE. IT WAS ALSO REPORTED THAT THE SHEATH HAD TO BE REMOVED FORCIBLY BECAUSE THE PATIENT WAS BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24684756 ↗
• MalfunctionMar 25, 2026Suction Problem; Air/Gas in Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR VIA THE RIGHT INTERNAL JUGULAR VEIN. DURING THE PROCEDURE, AIR LEAKAGE WAS DETECTED FROM THE INTRODUCER NEEDLE UPON INSERTION AT THE PUNCTURE SITE UNDER ULTRASOUND GUIDANCE, WITH NOTICEABLE GAS ASPIRATED THROUGH THE NEEDLE. IT WAS FURTHER REPORTED THAT BY FIRMLY PINCHING THE INTRODUCER NEEDLE HANDLE TO MINIMIZE FURTHER AIR ENTRY, THE CLINICIAN WAS ABLE TO CONTINUE THE PROCEDURE, AND SUBSEQUENT CANNULATION PROCEEDED SMOOTHLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684325 ↗
• InjuryMar 3, 2026Fracture; Material Separation; Deformation Due to Compressive Stress

  ON (b)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, THE TUNNELLER ALLEGEDLY BROKE OFF INTO PIECES WHILST ON THE PATIENT. REPORTEDLY, HALF OF THE TUNNELLER WAS EASILY REMOVED FROM THE SURGICAL SITE. HOWEVER, THE OTHER HALF OF THE METAL COMPONENT OF THE TUNNELLER REMAINED IN SITE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 24493967 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak; Fracture

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER HAD FRACTURED, RESULTING IN BLOOD SPURTING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24480551 ↗
• MalfunctionFeb 26, 2026Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A HEMODIALYSIS PROCEDURE USING THE HEMOSTAR. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE OUTER PACKAGING HAS SCRATCHES AND TEAR PRIOR TO OPENING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452686 ↗
• MalfunctionFeb 24, 2026Connection Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, INSPECTION OF THE DIALYSIS CATHETER REVEALED A MALFORMED CONNECTION AT THE LONG NEEDLE PORT, PREVENTING SYRINGE ATTACHMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426870 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  ON (B)(6) 2026, A PATIENT PREPPED FOR AN ULTRASOUND-GUIDED DIALYSIS CATHETER PLACEMENT PROCEDURE USING A HEMOSTAR HEMODIALYSIS CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE INTRODUCER NEEDLE ALLEGEDLY HAD A LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301889 ↗
• MalfunctionFeb 9, 2026Fracture; Material Separation; Stretched; Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE BY USING HEMOSTAR. IT WAS REPORTED THAT DURING PROCEDURE, THE CATHETER WAS ALLEGEDLY ADVANCED APPROXIMATELY HALFWAY WHEN THE FRONT BEND OF THE GUIDEWIRE BROKE CANNOT BE ADVANCED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289640 ↗
• MalfunctionFeb 6, 2026Fracture; Material Separation; Stretched; Unraveled Material; Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE KINKED AND PREVENTED SMOOTH PROGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276692 ↗
• MalfunctionJan 28, 2026Fracture; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED DIALYSIS CATHETER PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN, USING A HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE ASPIRATED BLOOD REVEALED THE PRESENCE OF GAS. SUBSEQUENT INSPECTION OF THE PUNCTURE NEEDLE REVEALED A CRACK IN THE HANDLE, CAUSING AIR LEAKAGE AND RENDERING THE NEEDLE UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197258 ↗
• MalfunctionJan 12, 2026Suction Problem; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE ASPIRATION WAS PERFORMED UNTIL A BREAKTHROUGH SENSATION WAS FELT WITHOUT BLOOD RETURN. REPEATED ATTEMPTS FAILED, SUGGESTING NEEDLE AIR LEAKAGE. FURTHERMORE, APPROXIMATELY 2ML OF BLOOD LOSS WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24033797 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak; Fracture; Suction Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE INSERTION OF THE NEEDLE INTO THE RIGHT INTERNAL JUGULAR VEIN, NO VENOUS RETURN WAS OBSERVED. ADDITIONALLY, THERE WAS LEAKAGE FROM AN INTRODUCER NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987166 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE BY USING AN INDWELLING DIALYSIS CATHETER. IT WAS REPORTED THAT BLOOD LEAKAGE FROM THE VENOUS END DUE TO A RUPTURE AT THE CATHETER INSERTION SITE. IMMEDIATE DRESSING WAS APPLIED TO CONTROL THE SEEPAGE, AND THE DIALYSIS SESSION WAS COMPLETED WITHOUT FURTHER INCIDENT. THE CATHETER WILL REQUIRE REPLACEMENT PRIOR TO THE NEXT SCHEDULED DIALYSIS SESSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987164 ↗
• MalfunctionDec 31, 2025Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR. DURING A HEMODIALYSIS TREATMENT IN THE CATHETERIZATION ROOM OF THE NEPHROLOGY UNIT, A LONG-TERM CATHETER WAS BEING IMPLANTED INTO THE RIGHT INTERNAL JUGULAR VEIN. WHILE INSERTING THE NEEDLE, CONTINUOUS AIR ASPIRATION OCCURRED, PREVENTING RAPID VASCULAR ACCESS. UPON INSPECTION, A FRACTURE WAS IDENTIFIED IN THE PLASTIC PORTION OF THE NEEDLE. THE PUNCTURE SITE WAS RELOCATED, AND THE PROCEDURE CONTINUED WITHOUT REPORTED ADVERSE EFFECTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932397 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE BY USING HEMOSTAR HEMODIALYSIS CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE WIRE ALLEGEDLY COULD NOT BE WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904259 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE BY USING HEMOSTAR HEMODIALYSIS CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE WIRE ALLEGEDLY COULD NOT BE WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904158 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE BY USING HEMOSTAR HEMODIALYSIS CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE WIRE ALLEGEDLY COULD NOT BE WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904157 ↗