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Hickman 0606560Recalls & reported problems

Bard Access Systems, Inc. · Hickman 10F Triple-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Cuff · Class 2 · Implant

All models of Hickman (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Quick summary

This Hickman central venous catheter is a long-term implanted vascular access device. The 81 reports mostly describe catheter fractures, leaks, and breaks; there are no deaths and 8 injuries. One recall is open, started December 2025, because outer tray damage may compromise the sterile barrier. Reports rose to 24 in the last 12 months, from 8 in the prior 12 months.

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
80
Deaths reported
0
Injuries reported
7
Recalls naming it
1

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00801741052019), received between Aug 31, 2017 and Jul 8, 2026 — classified as 7 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Fracture” (32 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 4 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 9 reportsMar 2026: 1 reportsApr 2026: 4 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520269
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 · Recall details · FDA record ↗

Most reported problems

Device problems

  • Fracture32
  • Fluid/Blood Leak27
  • Burst Container or Vessel13
  • Air/Gas in Device11
  • Material Puncture/Hole8
  • Break6
  • Material Deformation5
  • Restricted Flow rate4

Patient problems

  • No Clinical Signs, Symptoms or Conditions39
  • No Consequences Or Impact To Patient23
  • No Known Impact Or Consequence To Patient10
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
  • Bacteremia2
  • Bacterial Infection2
  • High Pulmonary Arterial Wedge Pressure2
  • Unspecified Infection2

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 8, 2026Fluid/Blood Leak; Fracture

    On (b)(6) 2026, a patient underwent a chronic catheter placement procedure using a Hickman/Leonard/Broviac Central Venous Catheter. On (b)(6) 2026, following the procedure, a small tear was observed in the blue lumen during flushing, along with a minor trickle of blood from the affected site. There was no reported patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25749506 ↗
  • MalfunctionMay 13, 2026Fracture

    THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER HAD RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25157850 ↗
  • MalfunctionMay 13, 2026Fracture

    THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER HAD RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25157841 ↗
  • MalfunctionApr 30, 2026Fluid/Blood Leak; Fracture; Material Split, Cut or Torn

    A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2026, THE PORT SPLIT AND STARTED LEAKING WHEN THE NURSE FLUSHED THE LINE. THERE WAS NO PATIENT REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25038977 ↗
  • MalfunctionApr 30, 2026Fluid/Blood Leak; Fracture; Material Split, Cut or Torn

    A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. ON (B)(6) 2026, THE PORT SPLIT AND STARTED LEAKING WHEN THE NURSE FLUSHED THE LINE. THERE WAS NO PATIENT REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25038972 ↗
  • MalfunctionApr 21, 2026Burst Container or Vessel; Fracture; Material Separation

    ON (B)(6) 2026, THE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING A HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE ON (B)(6) 2026, THE IMPLANTED CATHETER WAS REPORTED TO BE RUPTURED. THE AFFECTED CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER DEVICE ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24939494 ↗
  • MalfunctionApr 21, 2026Burst Container or Vessel; Fracture; Material Separation

    ON (B)(6) 2026, THE PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. POST THE PROCEDURE ON (B)(6) 2026, THE NURSING STAFF OBSERVED A RUPTURE IN THE LUMEN OF THE REPLACEMENT CATHETER. REPORTEDLY, THE CHEMOTHERAPY TREATMENT HAD NOT YET BEEN COMPLETED, THE CATHETER WAS TEMPORARILY COVERED UNTIL THE THERAPY CONCLUDED. AS PER THE RECOMMENDATION OF INTERVENTIONAL RADIOLOGY, THE CATHETER WAS REMOVED ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24939493 ↗
  • MalfunctionMar 24, 2026Material Puncture/Hole

    A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUSTOMER OBSERVED THE PRESENCE OF A HOLE IN THE CENTRAL VENOUS CATHETER (CVC). THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24679945 ↗
  • MalfunctionFeb 19, 2026Stretched; Material Protrusion/Extrusion; Air/Gas in Device

    ON (B)(6) 2025, A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT THE DEVICE SHOWED A BUBBLE. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24386180 ↗
  • MalfunctionFeb 19, 2026Air/Gas in Device

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385266 ↗
  • MalfunctionFeb 18, 2026Air/Gas in Device

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385172 ↗
  • MalfunctionFeb 18, 2026Air/Gas in Device

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385171 ↗
  • MalfunctionFeb 18, 2026Air/Gas in Device

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F. DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385168 ↗
  • MalfunctionFeb 18, 2026Fracture; Air/Gas in Device

    ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WHILE BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER WAS FOUND TO BE RUPTURED AND RESULTED IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS AND REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385121 ↗
  • MalfunctionFeb 18, 2026Fracture; Air/Gas in Device

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F. IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER RUPTURED, RESULTING IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS THIS REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385120 ↗
  • MalfunctionFeb 18, 2026Fracture; Air/Gas in Device

    ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT WHILE BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER WAS FOUND TO BE RUPTURED AND RESULTED IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS AND REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385118 ↗
  • MalfunctionFeb 18, 2026Fracture; Air/Gas in Device

    ON (B)(6) 2025, IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSPORTED TO THE OPERATING ROOM, THE HICKMAN CATHETER RUPTURED, RESULTING IN LOSS OF CENTRAL ACCESS. FURTHER, THERE WAS CREATION OF AN AIR BUBBLE IN ONE OF THE CATHETER PATHWAYS THIS REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24385116 ↗
  • MalfunctionJan 8, 2026Fracture

    A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F. POST THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN AND ISOLATED. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR AN EMERGENCY CATHETER REPLACEMENT. THERE WERE NO REPORTED PATIENT INJURIES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24000704 ↗
  • MalfunctionJan 6, 2026Air/Gas in Device

    A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE BY USING HICKMAN CATHETER. ON (B)(6) 2025, IT WAS REPORTED THAT DURING FLUSHING OF THE HICKMAN CATHETER, BUBBLES WERE OBSERVED. THE PROCEDURE WAS IMMEDIATELY INTERRUPTED, AND THE CATHETER WAS RENDERED UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23972236 ↗
  • MalfunctionJan 6, 2026Fracture; Air/Gas in Device

    A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE BY USING HICKMAN CATHETER. ON (B)(6) 2025, IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING TRANSPORTED TO THE OPERATING ROOM, THE CATHETER RUPTURED, RESULTING IN LOSS OF CENTRAL ACCESS. THIS REQUIRED AN EMERGENCY REPLACEMENT OF THE CATHETER TO ENSURE THE PATIENT COULD PROCEED WITH THE NECESSARY TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23972038 ↗
  • MalfunctionNov 19, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    ON (B)(6) 2024, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. ONE YEARS 9 MONTHS AND 5 DAYS POST PROCEDURE, THE LINE ALLEGEDLY HAD A LEAK. LINE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Bacteremia; Bacterial Infection; High Pulmonary Arterial Wedge Pressure; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23590802 ↗
  • InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (b)(6) 2024, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. ONE YEAR NINE MONTHS AND FOUR DAYS POST PROCEDURE THE PATIENT ALLEGEDLY REPORTED PULMONARY HYPERTENSION CNS AND ALSO TREATED FOR A STAPH AUREUS BACTEREMIA AND REMAINS AN INPATIENT. IV FLUCLOAXACILLIN AND IV GENTAMICIN GIVEN FOR THE INFECTION. LINE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Bacteremia; Bacterial Infection; High Pulmonary Arterial Wedge Pressure

    MAUDE report 23590795 ↗
  • MalfunctionNov 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN. IT WAS REPORTED THAT POST PROCEDURE, THE HICKMAN LINE WAS ALLEGEDLY HAD A HOLE IN THE WHITE LUMEN AND LEAK WAS FOUND IN THE WHITE LUMEN IMMEDIATELY DISTAL TO THE TRIFURCATIONS. THE CATHETER HAS BEEN REMOVED AND A PICC PLACED TO FURTHER FACILITATE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23447825 ↗
  • MalfunctionSep 15, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN. IT WAS REPORTED THAT POST PROCEDURE, ON (B)(6) 2025, THE HICKMAN LINE WAS ALLEGEDLY HAD A HOLE IN THE WHITE LUMEN. THE CATHETER HAS BEEN REMOVED AND A PICC PLACED TO FURTHER FACILITATE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23048675 ↗
  • MalfunctionAug 8, 2025Burst Container or Vessel; Fluid/Blood Leak; Fracture; Material Puncture/Hole; Burst Container or Vessel; Fluid/Blood Leak; Fracture; Material Puncture/Hole

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN TRIPLE LUMEN CATHETER. ON (B)(6) 2025, ONE MONTH AND FIVE DAYS LATER POST CHRONIC CATHETER PLACEMENT, THE DEVICE WAS ALLEGEDLY LEAKING WITH BLOOD FOLLOWING FLUSHING. IT WAS FURTHER REPORTED THAT THE LINE WAS ALLEGEDLY FOUND BURST. ON (B)(6) 2025, THE DEVICE WAS REMOVED. REINSERTION OF TUNNELED CVC TO COMPLETE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Erythema; Extravasation; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

    MAUDE report 22749958 ↗

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Sources and updates

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