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Hickman 0600560Recalls & reported problems

Bard Access Systems, Inc. · Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Bard Hickman catheter is a long-term tube placed in a large vein for ongoing treatment. Its 52 reports mostly describe cracking, holes and leaking, sometimes with clogging, and mention no deaths and 5 injuries. It has 1 open recall started in December 2025 about damage to the outer tray that could affect sterility.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
53
Deaths reported
0
Injuries reported
5
Recalls naming it
1

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741051845), received between Mar 11, 2016 and Sep 9, 2026 — classified as 5 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 4 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 12, 2025Open, Classified

    Due to damage to outer tray that can potentially compromise the sterile barrier

    Z-1367-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Fracture19
  • Fluid/Blood Leak10
  • Adverse Event Without Identified Device or Use Problem7
  • Material Puncture/Hole6
  • Break5
  • Obstruction of Flow5
  • Material Separation4
  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions33
  • No Consequences Or Impact To Patient8
  • No Known Impact Or Consequence To Patient6
  • Rash2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Foreign Body In Patient1
  • No Information1
  • Perforation of Vessels1

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2026Fracture; Improper or Incorrect Procedure or Method

    On (b)(6) 2026, the patient underwent a central venous catheter placement procedure using a Hickman CV Catheter. After some time, on (b)(6) 2026, it was noted that a crack had developed in the plastic hub due to improper clamping too close to the hub. There was no reported patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50690889 ↗
  • MalfunctionApr 30, 2026Material Puncture/Hole

    ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. PRIOR TO THE PROCEDURE, UPON OPENING THE PACKAGE, IT WAS NOTED THAT THERE WAS A HOLE IN THE CATHETER. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25038735 ↗
  • MalfunctionFeb 16, 2026Burst Container or Vessel; Fluid/Blood Leak; Difficult to Flush; Fracture; Obstruction of Flow; Air/Gas in Device

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2025, POST PLACEMENT PROCEDURE, A CRACK ALLEGEDLY DEVELOPED. DURING FLUSHING AFTER ADMINISTRATION, THE LINE REPORTEDLY BECAME CLOGGED, AND FLUSH FLUID WAS OBSERVED BUBBLING AND SUBSEQUENTLY SQUIRTING OUT OF THE CATHETER. THE ISSUE WAS RESOLVED FOLLOWING REPAIR OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24342739 ↗
  • MalfunctionNov 17, 2025Fracture; Nonstandard Device; Material Puncture/Hole; Fracture; Nonstandard Device; Material Puncture/Hole

    ON (B)(6) 2025 A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE CATHETER WAS ALLEGEDLY HAD A HOLE NEAR THE HUB THAT WAS NOTED UPON OPENING. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23566004 ↗
  • MalfunctionSep 15, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    ON (B)(6) 2025 A PATIENT UNDERWENT CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING A HICKMAN INSTRUMENT FOR UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE THE CATHETER WAS ALLEGEDLY FOUND LEAKING. THE PROCEDURE WAS DONE BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23051716 ↗
  • MalfunctionMar 27, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21705638 ↗
  • MalfunctionMar 7, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY SPLIT NEAR THE CUFF. IT WAS FURTHER REPORTED THAT THE INFUSION FLUID WAS LEAKING OUT OF THE CATHETER DURING INFUSION AND GOING ON HER SKIN. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21546428 ↗
  • MalfunctionMar 7, 2025Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

    IT WAS REPORTED THAT APPROXIMATELY FOUR-FIVE YEARS POST A CHRONIC CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A PINHOLE NEAR THE HUB OF THE CONNECTOR. IT WAS FURTHER REPORTED THAT THE LEAK WAS NOTED DURING INFUSE. THE PROCEDURE WAS COMPLETED BY EXCHANGING THE PINHOLE USING A REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21546194 ↗
  • MalfunctionMar 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE DOCUMENTED LENGTH IS FROM CUFF TO TIP OF LINE BUT NO INFORMATION NOTED ON REMAINDER OF LUMEN LENGTH. IT WAS FURTHER REPORTED THAT NO TOTAL CATHETER LENGTH ON PACKAGING EITHER WAS ALLEGEDLY MENTIONED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21543521 ↗
  • MalfunctionFeb 3, 2025Fracture; Material Separation; Fracture; Material Separation

    IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT, THE LINE WAS ALLEGEDLY FOUND TO BE IN HALF. IT WAS FURTHER REPORTED THAT APPROXIMATELY THREE INCHES OF THE CATHETER HAD SPLIT OFF. REPORTEDLY, THE CLAMP WAS ALSO OFF AND THE EXPOSED LENGTH OF THE CATHETER LEFT ON PATIENT APPROXIMATELY FIVE INCHES. ADDITIONALLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21291600 ↗
  • MalfunctionJan 1, 2025Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THAT ONE YEAR, FOUR MONTHS, AND SIXTEEN DAYS POST A PORT PLACEMENT. THE CATHETER ALLEGEDLY HAD BLOCKAGE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21051120 ↗
  • MalfunctionJul 1, 2024Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component

    IT WAS REPORTED THAT ELEVEN MONTHS AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE WHITE ADAPTOR END WAS ALLEGEDLY SEPARATED INTO TWO PIECES. IT WAS FURTHER REPORTED THAT THE TWO PIECES WERE GLUED TOGETHER BUT IT WAS UNSUCCESSFUL. REPORTEDLY, THE DEVICE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19641626 ↗
  • MalfunctionJun 14, 2024Fracture; Material Separation; Fracture; Material Separation

    IT WAS REPORTED THAT THREE WEEKS AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE CONNECTION OF THE CATHETER CAME LOOSE AND ALLEGEDLY BROKE OFF. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19535425 ↗
  • MalfunctionFeb 2, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THAT NINE MONTHS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT UPON RADIOLOGICAL CHECK, THE INSPECTION ALLEGEDLY SHOWED EXTRAVASATION OF CONTRAST MEDIUM THROUGH CRACKS IN THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18630041 ↗
  • MalfunctionJan 3, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THAT ONE YEAR AND EIGHT DAYS POST A CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18433272 ↗
  • InjuryJul 28, 2023Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE CUFF ALLEGEDLY CAUSED INFECTION. IT WAS FURTHER REPORTED THAT ANTIBIOTICS WERE PRESCRIBED TO TREAT INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 17411509 ↗
  • MalfunctionMay 27, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

    IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, WHEN THE CATHETER WAS ATTEMPTED TO BE INSERTED INTO THE SHEATH, THE CATHETER WAS ALLEGEDLY FOUND TO BE DAMAGED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND STOPPED INSERTING. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17015400 ↗
  • MalfunctionMar 2, 2023Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16465776 ↗
  • MalfunctionMar 2, 2023Expulsion; Expulsion

    IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST CATHETER PLACEMENT PROCEDURE, CATHETER ALLEGEDLY MIGRATED OUTSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT CUFF ALLEGEDLY EXPOSED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16465741 ↗
  • MalfunctionJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGY. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16135592 ↗
  • MalfunctionNov 17, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT SOME TIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY POWER INJECTED. IT WAS FURTHER REPORTED THAT THE IMPLANTED CATHETER IS A NOT A POWER INJECTABLE CATHETER. REPORTEDLY THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15812198 ↗
  • MalfunctionOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15578501 ↗
  • MalfunctionSep 20, 2022Fracture; Fracture

    IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE DEVICE DISTAL END ALLEGEDLY FRACTURED WHEN FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15453256 ↗
  • MalfunctionAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED SILICONE ALLERGY. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15181070 ↗
  • MalfunctionJul 30, 2022Fracture; Fracture

    IT WAS REPORTED THAT SOMETIMES POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKEN AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15136698 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.