Hickman TriFusion 0659230Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741036569), received between Apr 18, 2019 and Apr 20, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Fracture; Material Separation; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, THE DEVICE TUNNELLER ALLEGEDLY SNAPPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921551 ↗
• MalfunctionMay 25, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE TUNNELER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398140 ↗
• InjuryMay 15, 2024Fracture; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Fracture; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE TUNNELER HAD ALLEGEDLY BROKEN WHILE PULLING THROUGH THE CATHETER IN THE SOFT TISSUE. IT WAS FURTHER REPORTED THAT A PIECE OF THE TUNNELER WAS ALLEGEDLY NOT RETRIEVABLE AFTER SURGERY AND WAS STILL IN THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19317936 ↗
• MalfunctionOct 11, 2021Fracture; Fracture

  IT WAS REPORTED DURING PORT IMPLANTATION PROCEDURE, THE WHITE TUNNELER ON THE TRIFUSION CATHETER WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12603115 ↗
• MalfunctionDec 29, 2020Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED DURING PORT IMPLANTATION PROCEDURE, THE OUTER COAT OF THE TUNNELER ALLEGEDLY TORN. IT WAS FURTHER REPORTED THAT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086662 ↗
• MalfunctionDec 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE OUTER CORE WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11062266 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0659230 CENTRAL VENOUS CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK AND DETACHMENT OF DEVICE COMPONENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED INSIDE THE PATIENT, WITH NO REPORTED PATIENT INJURY. THE PATIENT INVOLVED IS (B)(6) YEARS OLD AND WEIGHS (B)(6) LBS. THE PATIENT'S GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529673 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0659230 CENTRAL VENOUS CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED INSIDE OF THE PATIENT, WITH NO REPORTED PATIENT INJURY. THE PATIENT INVOLVED IS A TWENTY-TWO YEAR-OLD, OF 119 LBS. PATIENT GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529508 ↗