HemoSplit Long-Term Hemodialysis Catheter 5743690Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741013263), received between Aug 14, 2018 and Apr 8, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fluid/Blood Leak; Material Puncture/Hole

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PREPARATION, A PINHOLE WAS FOUND IN THE ARTERIAL SEGMENT OF THE Y TUBE AND ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813195 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak; Fracture

  ON (B)(6) 2026, A PATIENT WHICH WAS SUFFERING FROM RENAL INSUFFICIENCY UNDERWENT A LONG-TERM DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. DURING THE PROCEDURE, STEAM LIKE AND PINHOLE LIKE LEAKAGE WAS OBSERVED AT THE CONNECTION POINT OF THE TRANSPARENT CONNECTING TUBE, WHICH INTERFERED WITH THE DIALYSIS TREATMENT. THE CATHETER WAS REMOVED AND A NEW DEVICE WAS REINSERTED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342067 ↗
• MalfunctionNov 21, 2025Packaging Problem; Packaging Problem

  ON(B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE. PRIOR TO A PLACEMENT PROCEDURE THE PACKAGING WAS ALLEGEDLY FOUND DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613690 ↗
• MalfunctionJul 30, 2025Loss of or Failure to Bond; Fracture; Material Separation; Loss of or Failure to Bond; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PROCEDURE USING A HEMOSPLIT CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER KRAFT HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668777 ↗
• MalfunctionJun 19, 2025Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT THE DIALYSIS CATHETER PLACEMENT USING HEMOSPLIT CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE DIALYSIS CATHETER SHEATH TUBING WAS ALLEGEDLY FOUND FRACTURED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291324 ↗
• MalfunctionJun 17, 2025Fracture; Device Damaged Prior to Use; Material Integrity Problem; Material Split, Cut or Torn; Fracture; Device Damaged Prior to Use; Material Integrity Problem; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. DURING THE PREPARATION OF THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS DAMAGED, AND A SMALL CUT WAS ALLEGEDLY FOUND IN THE TUBING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229371 ↗
• MalfunctionJun 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ON (B(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. DURING THE PREPARATION OF THE PROCEDURE, A HAIR WAS FOUND IN THE STERILE PACKAGING OF THE DIALYSIS CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217696 ↗
• MalfunctionMay 9, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT HEMOSPLIT CATHETER INSERTION FOR UNKNOWN MEDICAL CONDITION. DURING INSERTION THE CATHETER BROKE OUTSIDE THE BLOOD VESSEL, AND THE BROKEN PART DID NOT ENTER THE VASCULAR SYSTEM. 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 21991982 ↗
• MalfunctionMay 2, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT DIALYSIS CATHETER. DURING THE DIALYSIS, THERE WAS LEAKAGE FROM THE VENOUS END OF THE SILICONE AND POLYURETHANE PORTION OF THE SEMI-PERMANENT DIALYSIS CATHETER. REPORTEDLY CATHETER WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949183 ↗
• MalfunctionApr 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE; THE HAIR WAS ALLEGEDLY FOUND INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21795397 ↗
• MalfunctionMar 6, 2025Restricted Flow rate; Difficult to Flush; Suction Problem; Restricted Flow rate; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY NOTED POOR CATHETER FLOW. IT WAS FURTHER REPORTED THAT THE BLOOD FLOW FLUCTUATING BY 180-200 ML/MIN, WITH MULTIPLE MACHINE ALARMS REQUIRING TREATMENT SUCH AS THROMBOLYSIS WITH UROKINASE AND CLOSURE OF THE CATHETER, AFFECTING THE ADEQUACY OF DIALYSIS. ADDITIONALLY, THERE ARE PROBLEMS DURING INFUSION AND ASPIRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536195 ↗
• MalfunctionMar 6, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT SOMETIMES POST DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY NOTED POOR CATHETER FLOW. IT WAS FURTHER REPORTED THAT THE BLOOD FLOW FLUCTUATING, AFFECTING THE ADEQUACY OF DIALYSIS. DURING MULTIPLE DIALYSIS SESSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534442 ↗
• MalfunctionMar 5, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT FOUR MONTHS AND EIGHTEEN DAYS POST DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY NOTED POOR CATHETER FLOW. IT WAS FURTHER REPORTED THAT THE BLOOD FLOW FLUCTUATING, WITH MULTIPLE MACHINE ALARMS REQUIRING TREATMENT SUCH AS THROMBOLYSIS WITH UROKINASE AND CLOSURE OF THE CATHETER, AFFECTING THE ADEQUACY OF DIALYSIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525798 ↗
• MalfunctionMar 5, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT FIVE MONTHS AND TWELVE DAYS POST DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY NOTED POOR CATHETER FLOW. IT WAS FURTHER REPORTED THAT THE BLOOD FLOW FLUCTUATING, AFFECTING THE ADEQUACY OF DIALYSIS. DURING MULTIPLE DIALYSIS SESSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525353 ↗
• MalfunctionFeb 4, 2025Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TEAR OFF SHEATH ALLEGEDLY BREAKS AFTER UNPACKING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302433 ↗
• MalfunctionNov 25, 2024Restricted Flow rate; Difficult to Flush; Obstruction of Flow; Deformation Due to Compressive Stress; Restricted Flow rate; Difficult to Flush; Obstruction of Flow; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PIPE WORK OF THE DEVICE WAS ALLEGEDLY NOT CLEAR. IT WAS FURTHER REPORTED THAT THERE WAS A LOT OF RESISTANCE TO THE FLOW OF WATER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769263 ↗
• MalfunctionNov 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE INTRODUCER NEEDLE WAS ALLEGEDLY FOUND TO BE LEAKING, AND THE PROCEDURE COULD NOT BE COMPLETED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585453 ↗
• MalfunctionOct 9, 2024Degraded; Degraded

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY DISSOLVING WHICH RESULTED IN A DYSFUNCTIONAL CATHETER, WHICH PREVENTED THE COMPLETION OF NORMAL HEMODIALYSIS TREATMENTS. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405421 ↗
• MalfunctionSep 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY FOUND TO HAVE A BLOOD LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330496 ↗
• MalfunctionJul 9, 2024Degraded; Restricted Flow rate; Degraded; Restricted Flow rate

  IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD DETERIORATED AT THE CONNECTION BETWEEN THE ARTERIAL AND VENOUS ENDS OF THE CATHETER RESULTING IN INSUFFICIENT BLOOD FLOW THROUGH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698679 ↗
• MalfunctionJun 26, 2024Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA THE JUGULAR VEIN, THE CATHETER ALLEGEDLY LEAKED AND THE NEGATIVE PRESSURE ALLEGEDLY FAILED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611970 ↗
• MalfunctionDec 28, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE AIR LEAKAGE WAS ALLEGEDLY FOUND AFTER SUCTION AFTER CATHETERIZATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411642 ↗
• MalfunctionJul 17, 2023Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE WHITE RUBBER TUBE OF THE TUNNELLER INSIDE THE DIALYSIS CATHETER WAS ALLEGEDLY FOUND TO BE RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334999 ↗
• MalfunctionDec 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE CLIP WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16066288 ↗
• MalfunctionJul 8, 2022Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE INTRODUCER ALLEGEDLY HAD SUCTION ISSUE. IT WAS FURTHER REPORTED THAT THE PLASTIC PART OF THE NEEDLE LEAKED AIR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14953045 ↗