HemoSplit Long-Term Hemodialysis Catheter 5703690Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741012884), received between Dec 17, 2015 and May 4, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, THE FRONT END OF THE CATHETER WAS FOUND TO BE BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067222 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER ISP. DURING THE PREPARATION LEAKAGE WAS OBSERVED IN THE CATHETER LUMEN WHILE FLUSHING WITH HEPARIN SALINE SOLUTION UNDER POSITIVE PRESSURE PRIOR TO INSERTION. A NEW CATHETER WAS PROMPTLY REPLACED FOR FLUSHING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275776 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2025 A PATIENT UNDERWENT A PLACEMENT OF HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER. PRIOR TO THE PLACEMENT PROCEDURE WHILE ON SALINE PRIMING THE CATHETER WAS ALLEGEDLY FOUND LEAKAGE AT THE ARTERIAL END OF THE PROXIMAL EXTENSION TUBE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578827 ↗
• InjurySep 24, 2024Restricted Flow rate; Device Appears to Trigger Rejection; Obstruction of Flow; Restricted Flow rate; Device Appears to Trigger Rejection; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST A DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD POOR FLOW OF HEMODIALYSIS CATHETER. IT WAS FURTHER REPORTED THAT THE CEPHALIC END WAS ALLEGEDLY BLOCKED BY FIBRIN SHEATH AND BLOOD CLOTS IN THE BODY. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20288528 ↗
• MalfunctionJun 10, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE SYRINGE ALLEGEDLY HAD LEAKED AIR. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY LEAKED WATER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496524 ↗
• MalfunctionFeb 3, 2024Restricted Flow rate; Restricted Flow rate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637249 ↗
• MalfunctionSep 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PUNCTURE WAS NOT TIGHT, AND THE SALT WATER WAS PUMPED OUT OF THE NEEDLE. THE LEAKAGE OF PUNCTURE NEEDLE OF DIALYSIS TUBE CAUSE DISCOMFORT OF PATIENTS AND INCREASED PATIENTS' PAIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833713 ↗
• MalfunctionSep 28, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT FOUR MONTHS AND THIRTEEN DAYS POST DIALYSIS CATHETER PLACEMENT, BLOOD SEEPAGE WAS ALLEGEDLY FOUND ON THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD A TEAR IN THE TUBE BODY NEAR THE EXIT OF THE SKIN AND THE BLOOD ALLEGEDLY OOZED FROM THE TEAR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831799 ↗
• MalfunctionSep 26, 2023Difficult to Insert; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Insert; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE JUGULAR VEIN, THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO BE INSERTED AND TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE TIP OF THE GUIDEWIRE ALLEGEDLY GOT STUCK IN THE INTRODUCER NEEDLE. FURTHERMORE, THE TIP OF THE GUIDEWIRE WAS SEVERELY DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815788 ↗
• MalfunctionJul 24, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING FOUR MONTHS AND THIRTEEN DAYS POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY LEAKED BLOOD. IT WAS FURTHER REPORTED THAT A CRACK WAS ALLEGEDLY FOUND IN THE CATHETER BODY AT THE SKIN SURFACE OF PUNCTURE THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378109 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY LESS THAN TWO MONTHS POST DIALYSIS CATHETER PLACEMENT, BLOOD EXUDATION ALLEGEDLY OCCURRED FROM THE CATHETER BODY DURING ROUTINE DIALYSIS. IT WAS FURTHER REPORTED THAT THE CATHETER BODY HAD ALLEGEDLY CRACKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369514 ↗
• MalfunctionJun 21, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PREPARATION OF A PORT PLACEMENT PROCEDURE, A SMALL HOLE WAS ALLEGEDLY FOUND ON THE CATHETER AT THE CUFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169259 ↗
• MalfunctionSep 9, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT BLOOD LEAK OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12444951 ↗
• MalfunctionNov 5, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE PACKAGE OF THE PRODUCT WAS ALLEGEDLY UNABLE TO BE OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10789919 ↗
• MalfunctionJul 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING CATHETER IMPLANTATION IN RIGHT JUGULAR VEIN, THE NEEDLE JOINT ALLEGEDLY CRACKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306951 ↗
• MalfunctionMar 11, 2020Material Opacification; Stretched; Material Protrusion/Extrusion; Material Opacification; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS SEVENTEEN DAYS POST DIALYSIS CATHETER PLACEMENT, A BULGE WAS ALLEGEDLY FOUND ON THE CATHETER. REPORTEDLY, THE DIALYSIS CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818354 ↗
• MalfunctionJul 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER INSERTION PROCEDURE, AN ALLEGED AIR LEAK OCCURRED WITH THE INTRODUCER NEEDLE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXCHANGED WITH A NEW DIALYSIS CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841339 ↗
• MalfunctionJul 16, 2019Difficult to Insert; Component Missing; Difficult to Insert; Component Missing

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY COULD NOT FIRMLY ATTACH WITH THE TUNNELER FOR INSERTION. IT WAS FURTHER REPORTED THAT ANOTHER TUNNELER WAS USED AND CATHETER WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794653 ↗
• MalfunctionFeb 4, 2019Break; Corroded; Break; Corroded

  IT WAS REPORTED DURING PREPARATION, TUNNEL NEEDLE WAS IDENTIFIED RUSTY. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8303135 ↗
• MalfunctionSep 6, 2018Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT DURING PREPARATION FOR INTUBATING THE PATIENT, THE TUNNEL NEEDLE ALLEGEDLY HAD RUST ON IT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7853068 ↗
• MalfunctionDec 17, 2015Detachment Of Device Component

  IT WAS REPORTED BY DOCTOR THAT THE LONG TERM DIALYSIS CATHETER HAD BEEN USED FOR HALF A YEAR AND THE CUFF WAS FOUND DETACHED.

  Patient problems: No Information

  MAUDE report 5308789 ↗