HemoSplit Long-Term Hemodialysis Catheter 5735190Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741013188), received between Jul 23, 2019 and Apr 29, 2026 — classified as 3 deaths, 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 25025557 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 25025389 ↗
• DeathApr 29, 2026Deformation Due to Compressive Stress

  ON (B)(6), 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE WITH USE OF A HEMOSPLIT HEMODIALYSIS CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN. THE VENOUS PUNCTURE AND CATHETERIZATION WERE COMPLETED WITHOUT ISSUE; HOWEVER, AFTER THE CATHETER WAS ADVANCED THROUGH THE SUBCUTANEOUS TUNNEL AND INTO THE PUNCTURED JUGULAR VEIN, THE CLINICIAN ENCOUNTERED DIFFICULTY PROGRESSING THE DEVICE THROUGH THE SUPERIOR VENA CAVA DUE TO THE DEVICE'S CURVATURE AND RIGIDITY. UNDER FLUOROSCOPY, THE CATHETER TIP WAS NOTED TO BE KINKED AT THE SUPERIOR VENA CAVA RIGHT ATRIUM JUNCTION. IT WAS NOT POSSIBLE TO STRAIGHTEN THE CATHETER USING A GUIDEWIRE THAT WAS INSERTED INTO THE LUMENS. AFTER ATTEMPTING TO COMPLETELY REMOVE THE CATHETER, THE PATIENT SUFFERED A TRAUMATIC TEAR OF THE RIGHT ATRIUM REPORTEDLY DUE TO THE RIGID CATHETER. THE PATIENT SUBSEQUENTLY DEVELOPED A THROMBOSIS OF THE SUPERIOR VENA CAVA WITH ACUTE TAMPONADE. THE PATIENT WENT INTO CARDIAC ARREST AND REPORTEDLY EXPIRED.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Thrombosis/Thrombus

  MAUDE report 25024620 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) , 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THIS IS REPORT 3 OF 13.

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

  MAUDE report 24678404 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) , 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THIS IS REPORT 8 OF 13.

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

  MAUDE report 24671730 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THIS IS REPORT 12 OF 13.

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

  MAUDE report 24671729 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (b)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.THIS IS REPORT 2 OF 13.

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

  MAUDE report 24671726 ↗
• DeathMar 23, 2026Material Too Rigid or Stiff; Failure to Advance

  ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE WITH USE OF A HEMOSPLIT HEMODIALYSIS CATHETER IN TO THE RIGHT INTERNAL JUGULAR VEIN. THE VENOUS PUNCTURE AND CATHETERIZATION WERE COMPLETED WITHOUT ISSUE; HOWEVER AFTER THE CATHETER WAS ADVANCED THROUGH THE SUBCUTANEOUS TUNNEL AND INTO THE PUNCTURED JUGULAR VEIN, THE CLINICIAN ENCOUNTERED DIFFICULTY PROGRESSING THE DEVICE THROUGH THE SUPERIOR VENA CAVA DUE TO THE DEVICE'S CURVATURE AND RIGIDITY. UNDER FLUOROSCOPY, THE CATHETER TIP WAS NOTED TO BE KINKED AT THE SUPERIOR VENA CAVA RIGHT ATRIUM JUNCTION. IT WAS NOT POSSIBLE TO STRAIGHTEN THE CATHETER USING A GUIDEWIRE THAT WAS INSERTED INTO THE LUMENS. AFTER ATTEMPTING TO COMPLETELY REMOVE THE CATHETER, THE PATIENT SUFFERED A TRAUMATIC TEAR OF THE RIGHT ATRIUM REPORTEDLY DUE TO THE RIGID CATHETER. THE PATIENT SUBSEQUENTLY DEVELOPED A THROMBOSIS OF THE SUPERIOR VENA CAVA WITH ACUTE TAMPONADE. THE PATIENT WENT INTO CARDIAC ARREST AND REPORTEDLY EXPIRED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Thrombosis/Thrombus

  MAUDE report 24659469 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 22-YEAR-OLD PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. FOUR DAYS POST PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED EOSINOPHILIA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22824752 ↗
• 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 19907286 ↗
• 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 19907191 ↗
• MalfunctionJul 25, 2024Difficult to Flush; Suction Problem; Obstruction of Flow; Failure to Advance; Physical Resistance/Sticking; Difficult to Flush; Suction Problem; Obstruction of Flow; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, AN OCCLUSION HAD ALLEGEDLY OCCURRED IN THE VENOUS LUMEN AND IT GOT STUCK IN THE MIDDLE OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD ISSUES IN FLUSHING AND ASPIRATION PARTIALLY BLOCKED IN THE VENOUS LUMEN. FURTHERMORE, ATTEMPTS TO PASS A GUIDEWIRE THROUGH THE LUMEN ALSO INDICATED A PARTIAL BLOCKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824491 ↗
• MalfunctionApr 19, 2023Fracture; Material Separation; Stretched; Fracture; Material Separation; Stretched

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767505 ↗
• DeathAug 6, 2021Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY FIVE YEARS POST CATHETER PLACEMENT, VENOUS HUB OF CATHETER WAS ALLEGEDLY NOTED TO BE DISCONNECTED FROM THE LUMEN OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE BLOODLINE CONNECTOR REMAINED IN PLACE. BLOOD LOSS FROM DISCONNECTION NOTED. REPORTEDLY PATIENT EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 12286451 ↗
• MalfunctionMay 4, 2021Stretched; Stretched

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY DAMAGED AT ARTERIAL LUMEN HUB AND CATHETER WALL FORMED A BALLOON AT THE TIME OF FLUSHING. IT WAS FURTHER REPORTED THAT DURING ASPIRATION, BALLOON WAS ALLEGEDLY DEFLATING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768278 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED APPROXIMATELY TWO WEEKS POST DIALYSIS CATHETER PLACEMENT THAT THE EXTENSION LEG WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND A NEW DEVICE WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817074 ↗