Hickman TriFusion 0609230Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741036538), received between Apr 19, 2019 and Dec 16, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIFUSION CV CATHETER, TRIPLE LUMEN, 12F. POST THE PROCEDURE ON (B)(6) 2025, THE CLAMP WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813755 ↗
• MalfunctionJul 22, 2025Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Material Integrity Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT. DURING PREPARATION, IT WAS REPORTED THAT THE DEVICE WAS ALLEGEDLY FOUND DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564133 ↗
• MalfunctionAug 8, 2024Defective Component; Human-Device Interface Problem; Defective Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THERE WAS ALLEGEDLY NO VALVED PEEL AWAY IN THE TRAY FOR VESSEL ACCESS AND DEPARTMENT HAS TO DROP A SEPARATE VALVED PEEL AWAY TO KEEP TO SAFETY STANDARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936024 ↗
• MalfunctionAug 6, 2024Defective Component; Component Missing; Defective Component; Component Missing

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THERE WAS ALLEGEDLY NO VALVED PEEL AWAY IN THE TRAY FOR VESSEL ACCESS AND DEPARTMENT HAS TO DROP A SEPARATE VALVED PEEL AWAY TO KEEP TO SAFETY STANDARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915766 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE PLASTIC PIECE THAT COVERS THE TUNNELER ALLEGEDLY DISCONNECTED FROM THE TUNNELER AND REMAINED INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT SOMETIME POST A CATHETER PLACEMENT, THE CATHETER WAS REMOVED AND THE PATIENT COMPLAINED ABOUT THE DISCOMFORT AND THE PLASTIC PIECE WAS FOUND INSIDE THE PATIENT UNDER ULTRASOUND EXAMINATION. REPORTEDLY THE PLASTIC PIECE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927868 ↗
• InjuryMar 8, 2024Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE HOLE WAS ALLEGEDLY FOUND ON THE CATHETER JUST DISTAL TO THE CUFF. IT WAS FURTHER REPORTED THAT FLUID LEAK WAS ALLEGEDLY FOUND FROM THE INSERTION SITE AFTER FLUSHING. AFTER THE REMOVAL OF THE LINE, ALL THE THREE LUMENS WERE ALLEGEDLY LEAKED FROM A SPOT IN THE CATHETER JUST DISTAL TO THE CUFF. IT WAS ALSO REPORTED THAT CRACK WAS ALLEGEDLY FOUND AFTER THE LINE WAS REMOVED. FURTHERMORE, THE PATIENT EXPERIENCED EXTRAVASATION. HOWEVER, THE PATIENT WAS TREATED WITH MEDICATION. REPORTEDLY, THE CATHETER WAS PULLED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 18863324 ↗
• MalfunctionJan 19, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THREE MONTHS AND SIXTEEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKE UPON REMOVAL. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541016 ↗
• MalfunctionDec 7, 2023Loss of or Failure to Bond; Difficult to Remove; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST A CHRONIC CATHETER PLACEMENT, THE CUFF WAS ALLEGEDLY COULDN'T BE FOUND AND ALSO A PIECE OF PLASTIC WAS FOUND NEAR THE SITE. REPORTEDLY, EVERYTHING WAS SUCCESSFULLY REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282049 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, DEVICE ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679331 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS TEN DAYS POST CHRONIC CATHETER PLACEMENT, THE PATIENT WAS DIAGNOSED WITH BACTEREMIA, WHICH RESULTED IN HOSPITALIZATION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS AND CATHETER WAS REMOVED. THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE AND STUDY DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 14158344 ↗
• MalfunctionApr 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEBRIS NOTED AT THE HUB OF NEEDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14133133 ↗
• 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 12317685 ↗
• MalfunctionJul 22, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT, THE SHEATH ALLEGEDLY BROKE INTO TWO PIECES IN THE PATIENT'S CHEST WALL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208121 ↗
• MalfunctionApr 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE TREATMENT, THE TUNNELER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692916 ↗
• MalfunctionFeb 23, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TUNNELER ALLEGEDLY HAD A BREAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363941 ↗
• MalfunctionOct 26, 2020Fracture; Material Separation; Fracture; Material Separation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0609230 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FRACTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) OLD FEMALE PATIENT WEIGHS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738048 ↗
• MalfunctionApr 19, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0609230 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A MISSING COMPONENT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. OF THE ONE EVENT, ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532860 ↗