HemoSplit Long-Term Hemodialysis Catheter 5704150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741012907), received between Oct 5, 2017 and Feb 21, 2024 — classified as 4 malfunctions.

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

• MalfunctionFeb 21, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD TO BE REMOVED AS A SEMI-EMERGENCY MEASURE DUE TO A LEAK. IT WAS FURTHER REPORTED THAT WHEN WATER WAS INJECTED THROUGH THE BRANCHES OF THE REMOVED CATHETER, A DROP OF WATER ALLEGEDLY APPEARED AT THE POINT ON THE ROOT OF THE RED BRANCH WHERE THE BRANCHES BIFURCATE. FURTHERMORE, AIR BUBBLES WERE ALLEGEDLY NOTED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746318 ↗
• MalfunctionAug 28, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY UNRAVELED. IT WAS FURTHER REPORTED ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941032 ↗
• MalfunctionAug 2, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS ALREADY OPEN WHEN THE NURSE WENT TO OPEN IT. THERE WAS AN ALLEGED RIP/TEAR IN THE PACKAGE ITSELF. THIS WAS DISCOVERED BEFORE USE ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7745314 ↗
• MalfunctionOct 5, 2017Break

  IT WAS REPORTED THAT ONE CLAMP WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917739 ↗