Hickman TriFusion 0659190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741036552), received between Aug 26, 2021 and Apr 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE WHITE PLASTIC PIECE COVERING THE TUNNELER AND CATHETER TIP SLID OFF AND ENTERED THE TUNNEL TRACT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754520 ↗
• MalfunctionApr 1, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE WHITE PLASTIC PIECE COVERING THE TUNNELER AND CATHETER TIP SLID OFF AND ENTERED THE TUNNEL TRACT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754367 ↗
• MalfunctionNov 13, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE TUNNELING DEVICE ALLEGEDLY BROKE IN TWO WITHIN THE PATIENT'S TISSUE TRACT WHERE THE LINE WAS TUNNELED UNDER THE SKIN. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN PIECE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117711 ↗
• MalfunctionDec 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT PROCEDURE, CLAMP OF THE DEVICE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15957051 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE TUNNELER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER ALLEGEDLY BROKE INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948260 ↗
• MalfunctionAug 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT PROCEDURE, THE TUNNELER SHEATH WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE PHYSICIAN REMOVED THE BROKEN PIECE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370385 ↗