HemoSplit Long-Term Hemodialysis Catheter 5703730Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741012891), received between Jun 23, 2020 and Nov 1, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT PROCEDURE, THE CATHETER PUNCTURE NEEDLE WAS ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046564 ↗
• MalfunctionJul 7, 2023Break; Fracture; Suction Problem; Break; Fracture; Suction Problem

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PLASTIC AT THE JUNCTION OF THE PUNCTURE NEEDLE ALLEGEDLY CRACKED IN MANY PLACES DURING THE TUBE INSERTION, WHICH CAUSED THE NEEDLE TO FAIL TO DO NEGATIVE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277244 ↗
• MalfunctionDec 3, 2021Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Stretched; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE GUIDE WIRE COULD NOT BE ADVANCED AND GUIDEWIRE STUCK. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922426 ↗
• InjuryJun 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY FIFTEEN DAYS POST DIALYSIS CATHETER PLACEMENT, EXTERNAL PART OF THE CATHETER ALLEGEDLY RUPTURED, WHICH RESULTS IN RE-HOSPITALIZATION TO REMOVE THE REMAINING PART OF THE CATHETER. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10183692 ↗