HemoSplit Long-Term Hemodialysis Catheter 5733730Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00801741000454), received between Mar 24, 2016 and Mar 4, 2026 — classified as 1 death, 1 injury, 61 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Fracture; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT UNDERWENT CATHETER TUNNELING USING THE TUNNELER DEVICE, DURING WHICH THE WHITE PART OF THE CATHETER REPORTEDLY BROKE OFF AND REMAINED IN THE SUBCUTANEOUS TUNNEL. THE DEVICE WAS DIFFICULT TO EXTRACT, RESULTING IN LOSS OF TIME. THE PATIENT EXPERIENCED PAIN, ANXIETY, DISCOMFORT, AND DELAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Anxiety; Discomfort; Pain

  MAUDE report 24511766 ↗
• MalfunctionSep 26, 2025Fracture; Material Separation; Fracture; Material Separation

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. POST THE PROCEDURE, IT WAS REPORTED THAT THE TIP LUMENS OF THE CATHETER WERE ALLEGEDLY SEPARATED. IT WAS ALSO REPORTED THAT THE CATHETER LUMEN BROKE DURING WITHDRAWAL FROM THE SKIN, LEADING TO POST-PROCEDURAL CATHETER DYSFUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23152473 ↗
• MalfunctionAug 28, 2025Nonstandard Device; Suction Problem; Defective Component; Nonstandard Device; Suction Problem; Defective Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE HEMOSTATIC VALVE ON THE PEEL AWAY SHEATH FAILED, AND AIR WAS ¿SLURPED¿ IN BY THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915316 ↗
• MalfunctionJul 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT CATHETER. ON (B)(6) 2025, THE CUSTOMER WAS ALLEGEDLY CHANGING THE CLAMPING LOCATION OF THE CATHETERS TO PREVENT THEM FROM BENDING AND BREAKING. REPORTEDLY, THE CATHETER SHOWED MEMORY AND FOLDS IN THE SILICONE WHERE THE CLAMPING IS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528360 ↗
• MalfunctionJul 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT CATHETER. ON (B)(6) 2025, THE CUSTOMER WAS ALLEGEDLY CHANGING THE CLAMPING LOCATION OF THE CATHETERS TO PREVENT THEM FROM BENDING AND BREAKING. REPORTEDLY, THE CATHETER SHOWED MEMORY AND FOLDS IN THE SILICONE WHERE THE CLAMPING IS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528353 ↗
• MalfunctionSep 18, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BLOCKED. IT WAS FURTHER REPORTED THAT IT CAUSED A DISCOMFORT FOR THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247320 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWO MONTHS AND SIX DAYS POST A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE EXTENSION LEG OF THE CATHETER WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062890 ↗
• MalfunctionAug 5, 2024Material Discolored; Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation; Material Discolored; Melted; Material Opacification; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER INLET AND OUTLET LINE WAS ALLEGEDLY MOLDED AND MELTED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BECAME OFF WHITE COLOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905940 ↗
• MalfunctionAug 2, 2024Difficult to Flush; Obstruction of Flow; Failure to Advance; Difficult to Flush; Obstruction of Flow; Failure to Advance

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE VENOUS BRANCH WAS ALLEGEDLY OCCLUDED AND DOES NOT LET THE SERUM PASSED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY DID NOT PASS THROUGH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19897933 ↗
• MalfunctionJul 10, 2024Fluid/Blood Leak; Material Puncture/Hole; Difficult to Remove; Failure to Advance; Fluid/Blood Leak; Material Puncture/Hole; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY DIDN¿T STUCK BUT IT WAS NOT MOVING AHEAD. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED WITHOUT MUCH OF A DIFFICULTY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708969 ↗
• MalfunctionApr 26, 2024Loss of or Failure to Bond; Material Separation; Failure to Advance; Difficult or Delayed Separation; Loss of or Failure to Bond; Material Separation; Failure to Advance; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PEEL AWAY ALLEGEDLY DID NOT BREAK THE VALVE, FALLING IN THE MIDDLE OF THE PELL AWAY. IT WAS FURTHER REPORTED THAT IT WAS PREVENTING THE CATHETER FROM PASSING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192894 ↗
• MalfunctionFeb 28, 2024Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD NO BACK FLOW. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18795267 ↗
• MalfunctionJan 30, 2024Restricted Flow rate; Deformation Due to Compressive Stress; Material Integrity Problem; Restricted Flow rate; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT ONE YEAR, THREE MONTHS AND FIVE DAYS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER REPEATEDLY EXHIBITED VENOUS AND ARTERIAL CLAMPING DAMAGE ON BOTH LEGS, WHICH ALLEGEDLY LED TO FLOW LIMITATIONS. IT WAS FURTHER REPORTED THAT THE TUBE WAS ALLEGEDLY NARROWED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607575 ↗
• MalfunctionDec 22, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, A LEAKAGE WAS ALLEGEDLY FOUND FROM THE EXTENSION LINE BELOW THE HUB AREA. IT WAS FURTHER REPORTED THAT A LITTLE HOLE WAS ALLEGEDLY FOUND IN THE EXTENSION LINE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388760 ↗
• MalfunctionDec 22, 2023Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT TWO MONTHS AND ONE DAY POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY EXPELLED OUT WITH NO FIBROSIS. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY CAME OUT SPONTANEOUSLY FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381858 ↗
• MalfunctionNov 28, 2023Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY STUCK IN PEEL APART SHEATH. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215326 ↗
• MalfunctionNov 27, 2023Reflux within Device; Component Misassembled; Reflux within Device; Component Misassembled

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE COLOR CODE CONNECTOR WAS FOUND TO BE IN THE WRONG POSITION AS THE RED COLOR WAS IN THE BLUE POSITION AND THE BLUE COLOR WAS IN THE RED POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208081 ↗
• MalfunctionOct 11, 2023Moisture Damage; Unsealed Device Packaging; Moisture Damage; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER SEAL WAS VISIBLY OPENED BUT THE CONTENTS WERE INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912005 ↗
• MalfunctionOct 11, 2023Melted; Moisture Damage; Unsealed Device Packaging; Melted; Moisture Damage; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER SEAL WAS VISIBLY OPENED BUT THE CONTENTS WERE INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911473 ↗
• MalfunctionOct 10, 2023Moisture Damage; Unsealed Device Packaging; Packaging Problem; Moisture Damage; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PACKAGING WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER SEAL WAS VISIBLY OPENED BUT THE CONTENTS WERE INTACT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907159 ↗
• MalfunctionDec 27, 2022Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ONE MONTH POST DIALYSIS CATHETER PLACEMENT, THE LUMEN MATERIAL OF THE CATHETER WAS ALLEGEDLY BULGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049214 ↗
• MalfunctionJun 27, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PULL AWAY SHEATH AND HUB OF CATHETER WAS ALLEGEDLY HARD TO SEPARATE. IT WAS FURTHER REPORTED THAT THE CATHETER NOT BEING ABLE TO BE USED. REPORTEDLY THE DEVICE WAS IMPLANTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14825793 ↗
• MalfunctionJun 22, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PULL AWAY SHEATH AND HUB OF CATHETER WAS ALLEGEDLY HARD TO SEPARATE. IT WAS FURTHER REPORTED THAT THE CATHETER NOT BEING ABLE TO BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14769564 ↗
• MalfunctionJun 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PLASTIC PIECE ON THE TUNNELER WAS SHEARED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14586358 ↗
• MalfunctionMar 8, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT SOMETIMES POST DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT JUGULAR VEIN, AIR ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AIR EMBOLISM. THE DEVICE WAS REPORTED TO BE REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691800 ↗