HemoSplit Long-Term Hemodialysis Catheter 5733690Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00801741013096), received between Jan 14, 2016 and Sep 23, 2026 — classified as 8 injuries, 73 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fracture

  On (b)(6) 2026, a patient underwent a catheter placement procedure through the right internal jugular vein using a HemoSplit Hemodialysis Catheter. During the procedure, angiography confirmed that the guidewire was properly positioned. While inserting the new catheter, a fractured catheter tip was observed. The procedure was subsequently completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865161 ↗
• MalfunctionMar 12, 2026Deformation Due to Compressive Stress; Material Integrity Problem; Difficult or Delayed Separation

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING INSERTION, THE PEEL AWAY SHEATH WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580340 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE BY USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312586 ↗
• MalfunctionJan 23, 2026Stretched; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE ALLEGEDLY COULD NOT PASS THROUGH THE NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158681 ↗
• MalfunctionJan 2, 2026Loss of or Failure to Bond; Device Markings/Labelling Problem; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THROUGH HEMOSPLIT HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE PRODUCT LABELS WERE NOT ATTACHED CORRECTLY, WHICH RESULTED DAMAGE TO THE PRODUCTS INSIDE THE SHIPPING PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942854 ↗
• MalfunctionJan 2, 2026Loss of or Failure to Bond; Device Markings/Labelling Problem; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THROUGH HEMOSPLIT HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE PRODUCT LABELS WERE NOT ATTACHED CORRECTLY, WHICH RESULTED DAMAGE TO THE PRODUCTS INSIDE THE SHIPPING PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942842 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fracture; Material Split, Cut or Torn; Fluid/Blood Leak; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE HEMOSPLIT HEMODIALYSIS CATHETER EXPENDED LEGES, A CRACK WAS OBSERVED ON ONE OF THE LUMENS AND FLUID LEAK WAS NOTED ADDITIONALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288823 ↗
• MalfunctionSep 24, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER, FOR AN UNKNOWN MEDICAL CONDITION. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT TIP OF THE CATHETER ALLEGEDLY WAS BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23131102 ↗
• MalfunctionJul 25, 2025Fracture; Difficult to Remove; Material Separation; Stretched; Deformation Due to Compressive Stress; Material Twisted/Bent; Physical Resistance/Sticking; Fracture; Difficult to Remove; Material Separation; Stretched; Deformation Due to Compressive Stress; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY FELT RESISTANCE AND STUCK WHEN TRIED TO REMOVE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE HAD SOME COILING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607662 ↗
• MalfunctionMay 27, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING A HEMOSPLIT CATHETER. ON (B)(6) 2025, LEAKAGE IN VENOUS LINE OF HEMOSPLIT CATHETER WAS OBSERVED DURING DIALYSIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085674 ↗
• MalfunctionMay 14, 2025Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY STUCK IN THE INTRODUCER NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016934 ↗
• MalfunctionOct 13, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE TIP WAS ALLEGEDLY KINKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436162 ↗
• MalfunctionOct 3, 2024Material Integrity Problem; Air/Gas in Device; Material Integrity Problem; Air/Gas in Device

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY DAMAGED AT THE CLAMP. IT WAS FURTHER REPORTED THAT AN AIR LEAK WAS ALLEGEDLY FOUND IN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362211 ↗
• InjuryJul 18, 2024Backflow; Device Appears to Trigger Rejection; Suction Problem; Backflow; Device Appears to Trigger Rejection; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE DEVICE WAS ALLEGEDLY NOT FUNCTIONING WITH RESPECT TO ASPIRATION IN EITHER LUMEN. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD FIBRIN SHEATH FORMATION. REPORTEDLY THE INJECTED CONTRAST WAS FLOWING BACKWARD ALONG THE FIBRIN SHEATH. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 19769612 ↗
• MalfunctionMar 13, 2024Material Discolored; Material Opacification; Stretched; Material Protrusion/Extrusion; Material Discolored; Material Opacification; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SIX MONTHS AND ONE DAY POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER HUBS WERE ALLEGEDLY GETTING WEAKER, CAUSING BALLOONING WHILE FLUSHING. IT WAS FURTHER REPORTED THAT THE COLOR OF THE CATHETER HUB WAS ALLEGEDLY CHANGED TO PALE YELLOW. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899908 ↗
• 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 17911663 ↗
• MalfunctionOct 9, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE LEAKAGE WAS ALLEGEDLY FOUND FROM THE EXTENSION LINE BELOW THE HUB AREA. IT WAS FURTHER REPORTED THAT A CRACK 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 17894510 ↗
• MalfunctionAug 14, 2023Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CAME OUT BY ITSELF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539217 ↗
• MalfunctionAug 7, 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 FOUR DAYS POST DIALYSIS CATHETER PLACEMENT, THE CUFFS APPEARED PAPERY WITH NO FIBROSIS. IT WAS FURTHER REPORTED THAT CATHETER WAS ALLEGEDLY CAME OUT FROM THE PATIENT SPONTANEOUSLY. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469029 ↗
• MalfunctionJul 20, 2023Fracture; Material Separation; Separation Failure; Deformation Due to Compressive Stress; Material Twisted/Bent; Fracture; Material Separation; Separation Failure; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE HEALTHCARE PERSONNEL FOUND THAT THE SHEATH HAD ALLEGEDLY FRACTURED BEFORE BEING USED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE HAD ALLEGEDLY BECOME TORTUOUS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359386 ↗
• MalfunctionJul 5, 2023Material Discolored; Fluid/Blood Leak; Material Discolored; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE MONTH AND THREE DAYS POST DRAINAGE CATHETER PLACEMENT, WHILE FLUSHING WITH SALINE, SWELLING WAS ALLEGEDLY NOTED. IT WAS FURTHER REPORTED THAT LEAKAGE WAS ALLEGEDLY FOUND IN THE CATHETER UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259835 ↗
• MalfunctionJun 1, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER SHEATH ALLEGEDLY DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036748 ↗
• MalfunctionMay 22, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT FOURTEEN DAYS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT BLOOD WAS LEAKING FROM THE RUPTURED PART. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974417 ↗
• MalfunctionMay 15, 2023Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, AIR WAS ALLEGEDLY SUCKED IN UNDER NEGATIVE PRESSURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928933 ↗
• MalfunctionDec 19, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PLASTIC CONNECTOR IN THE TUNNELLER ALLEGEDLY BROKE INTO TWO PIECES WHILE TUNNELING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002211 ↗