HemoSplit Long-Term Hemodialysis Catheter 5733734Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741013140), received between Mar 21, 2018 and Aug 29, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionAug 29, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE HD CATHETER WAS REMOVED AND THE CUFF WAS NOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7830987 ↗
• MalfunctionMar 21, 2018Material Frayed

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL EXPERIENCED DIFFICULTY REMOVING THE WIRE. ONCE THE WIRE WAS REMOVED IT WAS ALLEGED TO BE FRAYED. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359527 ↗