HemoSplit Long-Term Hemodialysis Catheter 5704190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741012914), received between Apr 27, 2020 and Apr 16, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fracture

  THE CUSTOMER REPORTED THAT ON MAR 23, 2026, THE HEMOSPLIT HEMODIALYSIS CATHETER IS FUNCTIONING PROPERLY, BUT ONE OF THE CLAMPS IS CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902190 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT; AFTER PLACING THE PEEL-AWAY SHEATH AND REMOVAL OF THE PREMOUNTED-DILATOR, BLOOD WAS ALLEGEDLY LEAKED THROUGH THE INLET LIKE NO VALVE WAS PRESENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057414 ↗
• MalfunctionFeb 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE NON-FUNCTIONAL HEMOSTATIC VALVE ALLEGEDLY LEAKED BLOOD WHEN REMOVAL OF THE DILATOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738971 ↗
• InjuryMay 6, 2020Material Opacification; Stretched; Material Protrusion/Extrusion; Material Opacification; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER WALL WAS ALLEGEDLY BLISTERING AND WAS AT A RISK OF RUPTURE. IT WAS FURTHER REPORTED THAT THE CATHETER SITE WAS TREATED WITH AN ANTIBIOTIC FOR SWELLING OF THE SURROUNDING TISSUES. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Swelling

  MAUDE report 10029641 ↗
• MalfunctionApr 27, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE GUIDE WIRE WAS ALLEGEDLY FOUND TO BE BROKEN AT THE BENDING PART. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10002905 ↗