HemoSplit Long-Term Hemodialysis Catheter 5733694Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741013119), received between May 20, 2022 and May 20, 2022 — classified as 2 deaths.

The most frequently reported specific device problem is “Restricted Flow rate” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMay 20, 2022Restricted Flow rate; Suction Problem; Restricted Flow rate; Suction Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT SOMETIME POST INDEX PROCEDURE COMPLETION, DEVICE FAILURE NOTED. POST INSERTION ATTEMPTED DIALYSIS, UNABLE TO USE DUE TO NO PULLS OR SLUGGISH FLOW FROM VENOUS PORT AND WAS NOT SUCCESSFULLY TREATED WITH HEMOSPLIT CATHETER DUE TO DYSFUNCTION. APPROXIMATELY SEVEN MONTHS AND TEN DAYS POST INDEX PROCEDURE COMPLETION, THE PATIENT WAS EXPIRED.

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

  MAUDE report 14461860 ↗
• DeathMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY SIXTEEN DAYS POST INDEX PROCEDURE COMPLETION, THE PATIENT WAS EXPIRED.

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

  MAUDE report 14460959 ↗