HemoSplit Long-Term Hemodialysis Catheter 5743730Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741013287), received between Feb 10, 2017 and May 8, 2026 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture

  ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. DURING USE, THE SHEATH TORE WITH THE OPENING OF THE TUBING RUPTURING SPONTANEOUSLY BEFORE IT WAS INTENTIONALLY TORN OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121584 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  ON (B)(6) , 2025, A PATIENT PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, DURING PREPARATION, LEAKAGE WAS DISCOVERED IN THE COMPONENTS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762514 ↗
• MalfunctionJun 17, 2025Fracture; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Fracture; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT THE DIALYSIS CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE USING A HEMOSPLIT CATHETER, EXTENSION TUBING WAS BROKEN. EXTENSION TUBE HAS CREASES AND HOLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217514 ↗
• InjuryFeb 24, 2025Restricted Flow rate; Suction Problem; Restricted Flow rate; Suction Problem

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD POOR FLOW RATE. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY AN ASPIRATION ISSUE. FURTHERMORE, THE PATIENT WAS ALLEGEDLY FOUND TO BE DIAGNOSED WITH THROMBOSIS. THE PATIENT STATUS IS REPORTED TO BE STABLE NOW.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21447337 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED HIGH FEVER WITH CHILLS AND CHILLS AFTER THE OPERATION. IT WAS FURTHER REPORTED THAT THE URINE CULTURE, BLOOD CULTURE, AND CATHETER BLOOD CULTURE WERE PERFECTED TO CLARIFY THE PATHOGENIC BACTERIA, AND PIPERACILLIN TAZOBACTAM WAS EMPIRICALLY ADMINISTERED TO FIGHT INFECTION FOR THE TIME BEING. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 21393214 ↗
• MalfunctionFeb 13, 2025Restricted Flow rate; Obstruction of Flow; Restricted Flow rate; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD POOR FLOW RATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372564 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT IN THE LEFT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED HIGH FEVER WITH CHILLS AND CHILLS AFTER THE OPERATION. IT WAS FURTHER REPORTED THAT THE URINE CULTURE, BLOOD CULTURE, AND CATHETER BLOOD CULTURE WERE PERFECTED TO CLARIFY THE PATHOGENIC BACTERIA, AND PIPERACILLIN TAZOBACTAM WAS EMPIRICALLY ADMINISTERED TO FIGHT INFECTION FOR THE TIME BEING. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 21372563 ↗
• MalfunctionFeb 13, 2025Restricted Flow rate; Obstruction of Flow; Restricted Flow rate; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD POOR FLOW RATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372295 ↗
• MalfunctionJul 23, 2024Fracture; Difficult to Insert; Suction Problem; Air/Gas in Device; Fracture; Difficult to Insert; Suction Problem; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PUNCTURE NEEDLE ALLEGEDLY HAD NO NEGATIVE PRESSURE AND WAS LEAKING AIR. IT WAS FURTHER REPORTED THAT THE BLOOD VESSEL PUNCTURE COULD NOT BE PERFORMED, AND A CRACK WAS FOUND DURING INSPECTION. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804023 ↗
• MalfunctionApr 11, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE FLOW WAS ALLEGEDLY INSUFFICIENT IN THE LONG-TERM CATHETER FOR HEMODIALYSIS. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087024 ↗
• MalfunctionOct 5, 2023Fracture; Difficult to Insert; Air/Gas in Device; Fracture; Difficult to Insert; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PUNCTURE NEEDLE ALLEGEDLY LEAKED AIR WITHOUT NEGATIVE PRESSURE AND THE PUNCTURE COULD NOT BE PERFORMED. IT WAS FURTHER REPORTED THAT AN OBVIOUS CRACK WAS ALLEGEDLY OBSERVED ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876735 ↗
• MalfunctionOct 5, 2023Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PUNCTURE NEEDLE ALLEGEDLY LEAKED AIR WITHOUT NEGATIVE PRESSURE AND THE PUNCTURE COULD NOT BE PERFORMED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A CRACK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876441 ↗
• MalfunctionJun 22, 2022Collapse; Material Discolored; Material Opacification; Material Deformation; Collapse; Material Discolored; Material Opacification; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE CATHETER ALLEGEDLY GOT THIN AND COLLAPSED IN THE LEFT POSTERIOR ORGAN CAVITY. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14768676 ↗
• MalfunctionDec 27, 2021Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO THE DIALYSIS CATHETER PLACEMENT PROCEDURE, THE OUTER PACKAGE ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087679 ↗
• MalfunctionJul 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE SHEATH WAS ALLEGEDLY UNABLE TO PEEL. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148514 ↗
• MalfunctionJan 6, 2021Fracture; Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED THAT THE CONNECTOR FOR INTRODUCER NEEDLE WAS ALLEGEDLY DAMAGED AND WAS LEAKING AIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122171 ↗
• MalfunctionJan 5, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT, UPON OPENING THE PACKAGE THE INTRODUCER NEEDLE WAS ALLEGEDLY MISASSEMBLED IN THE KIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115574 ↗
• MalfunctionAug 26, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE ON THE RIGHT JUGULAR VEIN, AFTER OPENING THE PACKAGE THE PEELABLE SHEATH WAS ALLEGEDLY FOUND MISSING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452820 ↗
• MalfunctionJun 3, 2020Material Opacification; Material Deformation; Material Opacification; Material Deformation

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT DURING THE TREATMENT OF CHRONIC RENAL FAILURE, THE CATHETER ALLEGEDLY EMULSIFIED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10114161 ↗
• MalfunctionJun 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY EMULSIFIED. IT WAS FURTHER REPORTED THAT THE DEVICE WILL BE REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113821 ↗
• MalfunctionOct 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST DIALYSIS CATHETER USE, THERE WAS ALLEGED EMULSIFICATION OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216061 ↗
• MalfunctionOct 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST DIALYSIS CATHETER USE, THERE WAS ALLEGED EMULSIFICATION OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215966 ↗
• MalfunctionOct 21, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST DIALYSIS CATHETER USE, THERE WAS ALLEGED EMULSIFICATION OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215964 ↗
• MalfunctionOct 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST DIALYSIS CATHETER USE, THERE WAS ALLEGED EMULSIFICATION OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9211599 ↗
• MalfunctionApr 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST CATHETER PLACEMENT, THE EXTENSION LEG ALLEGEDLY TURNED WHITE AND BECAME DEFORMED. IT WAS FURTHER REPORTED THAT THE DEFORMATION CONTINUED AND AFFECTED BLOOD FLOW VOLUME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533484 ↗