Hickman TriFusion 0609270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741036545), received between Nov 1, 2020 and Sep 9, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Integrity Problem

  A patient was prepped for a chronic catheter placement procedure using the Hickman TriFusion CV Catheter. Prior to the procedure, it was noted the goods were allegedly damaged. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50687611 ↗
• InjuryMar 3, 2026Fracture; Material Separation; Device Dislodged or Dislocated; Migration

  ON (B)(6) 2026, THE PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HICKMAN TRIFUSION CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, THE PLASTIC PIECE COVERING THE CONNECTION POINT BETWEEN THE TUNNELER AND THE CATHETER REPORTEDLY SLID OFF THE TUNNELER AND TRAVELED DOWN THE CATHETER BENEATH THE PATIENT¿S SKIN, RESULTING IN A FOREIGN BODY LEFT INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WITH THE TUNNELED LINE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Discomfort; Foreign Body In Patient

  MAUDE report 24495000 ↗
• MalfunctionJan 19, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT, THE LUMEN WITH THE RED INDICATOR WAS COMPLETELY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287655 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE PATIENT ALLEGEDLY STARTED BLEEDING. THE DEVICE WAS REMOVED OFF THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12479032 ↗
• InjuryAug 13, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE SLEEVES THAT WERE OVER THE CATHETER AFTER IT¿S CONNECTED WITH THE TUNNELER WERE ALLEGEDLY MUCH LARGER AND RESULTS IN CREATING A SPACE THAT IS NOT FILLED BY THE CATHETER. THE PATIENT EXPERIENCES BLEEDING; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12317689 ↗
• MalfunctionDec 22, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LUMEN AND CLAMP WERE ALLEGEDLY DETACHED FROM THE DISTAL LUMEN. REPORTEDLY, LUER CONNECTOR WAS MISSING FROM THE DISTAL LUMEN ALONG WITH THE CLAMP ON THE LUMEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11053739 ↗
• MalfunctionNov 1, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE CAME WITH THE PACKAGE OPEN AND UNSEALED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10768274 ↗