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Hickman 0600650Recalls & reported problems

Bard Access Systems, Inc. · Hickman 12.5 Fr Triple-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 triple-lumen central venous catheter is used for long-term IV access. Reports mostly describe catheters cracking, leaking or puncturing; there were 12 injuries, no deaths and 76 total reports. One open recall began in December 2025 because damage to the outer tray could compromise the sterile barrier.

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
82
Deaths reported
0
Injuries reported
12
Recalls naming it
1

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00801741051975), received between Jul 14, 2017 and Sep 24, 2026 — classified as 12 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Fracture” (38 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: 0 reportsFeb 2024: 0 reportsMar 2024: 2 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: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 2 reportsOct 2025: 4 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 0 reportsMar 2026: 2 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 1 reportsJul 2026: 2 reportsAug 2026: 0 reportsSep 2026: 4 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

  • Fracture38
  • Fluid/Blood Leak28
  • Material Puncture/Hole20
  • Burst Container or Vessel10
  • Material Protrusion/Extrusion5
  • Stretched5
  • Material Separation4
  • Suction Problem4

Patient problems

  • No Clinical Signs, Symptoms or Conditions52
  • No Consequences Or Impact To Patient12
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
  • No Known Impact Or Consequence To Patient4
  • No Patient Involvement4
  • Extravasation2
  • Unspecified Infection2
  • Bacterial Infection1

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Fracture

    On (b)(6) 2026, a patient underwent a Central venous catheter placement procedure using Hickman/Leonard/Broviac Central Venous Catheter. After some time, it was noted that the catheter had ruptured, so the catheter was removed on (b)(6) 2026. The procedure was completed using another device. There was no reported patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50880535 ↗
  • MalfunctionSep 24, 2026Fracture

    On (b)(6) 2026, a patient underwent a Central venous catheter placement procedure using Hickman/Leonard/Broviac Central Venous Catheter. After some time, it was noted that the catheter had ruptured, so the catheter was removed on (b)(6) 2026. The procedure was completed using another device. There was no reported patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50880534 ↗
  • MalfunctionSep 22, 2026Fluid/Blood Leak; Fracture

    On (b)(6) 2026, a patient underwent a Central venous catheter placement procedure using Hickman/Leonard/Broviac Central Venous Catheter. After 15 days, the catheter had ruptured and was leaking. There was no reported patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50851090 ↗
  • MalfunctionSep 10, 2026Fracture

    On (b)(6) 2026, a patient underwent a central venous catheter placement procedure using a Hickman/Leonard/Broviac Central Venous Catheter. Post the procedure on (b)(6) 2026, it was reported that a split in the triple lumen Hickman catheter line was noted. The catheter was removed from the patient and replaced with a different type of central line. The procedure was completed using the replacement device. There was no reported patient injury.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50710931 ↗
  • MalfunctionJul 28, 2026Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50048805 ↗
  • InjuryJul 1, 2026Fracture

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A CENTRAL VENOUS CATHETER. FOLLOWING THE PROCEDURE, THE LINE REQUIRED MULTIPLE REINSERTIONS DUE TO BLEEDING, WHICH WAS CONSIDERED A CONTRIBUTING FACTOR TO THE OBSERVED CATHETER DAMAGE. DESPITE THIS, THE CATHETER WAS NOTED TO HAVE CRACKED AT THE BIFURCATION POINT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 25675061 ↗
  • MalfunctionJun 16, 2026Fluid/Blood Leak

    ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. POST PROCEDURE ON (B)(6) 2026, THE CATHETER WAS ALLEGEDLY FOUND LEAKED. ON (B)(6) 2026, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Burning Sensation; No Clinical Signs, Symptoms or Conditions

    MAUDE report 25517273 ↗
  • MalfunctionMay 27, 2026Fluid/Blood Leak; Material Puncture/Hole

    A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. FOLLOWING THE PROCEDURE, IT WAS OBSERVED THAT THE BLUE-COLORED LUMEN HAD A SMALL HOLE, RESULTING IN SALINE SPRAYING FROM THE LUMEN. REPORTEDLY, ON (B)(6) 2025, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25296800 ↗
  • MalfunctionApr 22, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole

    ON (B)(6) 2026, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. 6 DAYS POST THE PROCEDURE THERE WAS HOLE AND LEAK NOTED IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24950045 ↗
  • MalfunctionMar 25, 2026Fracture

    On March 05, 2026, it was reported that an external catheter fracture was identified during routine care, and no medication was administered at the time the fracture was identified. Reportedly, the catheter line was isolated with sterile gauze and micropore tape. It was further reported that the patient expired due to unspecified causes. The relationship of the adverse event was determined to be not related to the device and not related to the reported external catheter fracture.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24695183 ↗
  • MalfunctionMar 9, 2026Stretched; Material Protrusion/Extrusion

    ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. IT WAS REPORTED THAT THE WHILE FLUSHING THE WHITE LUMEN OF THE CATHETER, A BULGE MEASURING APPROXIMATELY 10 TO 15 MM WAS OBSERVED JUST PROXIMAL TO THE THICKEST PORTION OF THE WHITE LUMEN. THE BALLOON LIKE BULGE RESOLVED IMMEDIATELY AFTER FLUSHING. NO RESISTANCE WAS ENCOUNTERED DURING FLUSHING, AND BLOOD ASPIRATION WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24542633 ↗
  • InjuryJan 7, 2026Migration

    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 PROCEDURE THE LINE ALLEGEDLY DISLODGED AND MIGRATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 23987039 ↗
  • InjuryJan 6, 2026Fracture

    ON (B)(6) 2025, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING A HICKMAN CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REFERRED BACK TO THE OPERATING ROOM FOR AN EMERGENCY CATHETER REPLACEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 23971349 ↗
  • MalfunctionJan 5, 2026Fluid/Blood Leak; Material Puncture/Hole

    ON (B)(6) 2025, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PROCEDURE USING THE TRIPLE LUMEN HICKMAN CV CATHETER. IT WAS REPORTED THAT THE TINY HOLE OR LEAK IN THE WHITE LUMEN, LOCATED IN DISTAL TO THE CLAMP AND ADJACENT TO THE IMPRINTED MEASUREMENT MARKINGS. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23954509 ↗
  • MalfunctionNov 5, 2025Material Puncture/Hole; Stretched; Material Protrusion/Extrusion; Material Puncture/Hole; Stretched; Material Protrusion/Extrusion

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F. POST THE PROCEDURE ON (B)(6) 2025, IT WAS REPORTED THAT THE WHITE LUMEN OF THE CATHETER WAS OBSERVED TO BE BULGED/BALLOONED. FURTHERMORE, ON THE SAME DAY, THE CATHETER WAS REMOVED. THERE WERE NO REPORTED PATIENT INJURIES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23475889 ↗
  • MalfunctionNov 5, 2025Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A CHRONIC CATHETER PLACEMENT USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F. ON (B)(6) 2025, DURING A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE THE DEVICE WAS ALLEGEDLY FOUND BULGED DURING INFUSION. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23473882 ↗
  • MalfunctionOct 24, 2025Material Puncture/Hole; Material Puncture/Hole

    ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER. ON (B)(6) 2025, POST THE PLACEMENT PROCEDURE, IT WAS REPORTED THAT THERE WAS A HOLE WAS NOTED AT THE BLUE LUMEN OF CATHETER WHILE FLUSHING WITH NORMAL SALINE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23376733 ↗
  • InjuryOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    ON (B)(6) 2025, A PATIENT UNDERWENT A CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. POST PROCEDURE IT WAS REPORTED THAT THE BLUE LUMEN OF CATHETER WAS ALLEGEDLY FOUND CLEAR FLUID LEAKED FROM EXIT SITE OF CATHETER WHILE FLUSHING WITH NORMAL SALINE. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED FEELING LIQUID INSIDE. 1 MONTH AND 11 DAYS POST PROCEDURE THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Extravasation

    MAUDE report 23376684 ↗
  • MalfunctionOct 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

    ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER. ON (B)(6) 2025, POST PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE BLUE LUMEN OF CATHETER WAS ALLEGEDLY FOUND BULGING WHILE FLUSHING WITH NORMAL SALINE. REPORTEDLY, PATIENT REQUIRED A SEPARATE SURGICAL INTERVENTION FOR REPLACEMENT OF THE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23376683 ↗
  • MalfunctionOct 15, 2025Material Puncture/Hole; Material Puncture/Hole

    ON (B)(6) 2025, A PATIENT UNDERWENT A HICKMAN T/L CATHETER PROCEDURE. DURING THE PROCEDURE, AN ISSUE WAS OBSERVED WHILE FLUSHING THE CATHETER WITH NORMAL SALINE, DURING WHICH A HOLE APPEARED IN THE BLUE LUMEN. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23297895 ↗
  • MalfunctionSep 30, 2025Burst Container or Vessel; Stretched; Material Protrusion/Extrusion; Burst Container or Vessel; Stretched; Material Protrusion/Extrusion

    ON (B)(6) 2025, A PATIENT WAS UNDERGOING A CATHETER PLACEMENT PROCEDURE, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LUMEN WAS ALLEGEDLY FOUND BALLOONED WHERE REINFORCED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23177674 ↗
  • MalfunctionSep 24, 2025Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

    ON (B)(6) 2025, DURING DRUG ADMINISTRATION OF 3CC, IT WAS REPORTED THAT THE HUB OF THE DEVICE ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23130420 ↗
  • MalfunctionAug 14, 2025Fluid/Blood Leak; Difficult to Flush; Fracture; Material Puncture/Hole; Suction Problem; Fluid/Blood Leak; Difficult to Flush; Fracture; Material Puncture/Hole; Suction Problem

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CV CATHETER. DURING THE PROCEDURE, THE BLUE LUMEN WAS ALLEGEDLY FOUND LEAKED. IT WAS FURTHER REPORTED THAT THE LINE WAS ALLEGEDLY FOUND SMALL HOLE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22802551 ↗
  • InjuryJul 24, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN CATHETER. IT WAS REPORTED THAT, 1 MONTH AND 11 DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY LEAKED FROM EXIT SITE, ON (B)(6) 2025. IT WAS FURTHER REPORTED THAT THIS RESULTED IN INJURY OR IMPAIRMENT REQUIRING MEDICAL INTERVENTION. ON (B)(6) 2025, THE DEVICE WAS EXPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 22584896 ↗
  • MalfunctionMay 12, 2025Fluid/Blood Leak; Fracture; Reflux within Device; Fluid/Blood Leak; Fracture; Reflux within Device

    ON (B)(6) 2025 A MALE PATIENT UNDERWENT FOR CHRONIC CATHETER INSERTED. ON (B)(6) 2025 IT WAS REPORTED THAT FOUR DAYS LATER, POST A CHRONIC CATHETER PLACEMENT, THE LUMEN WAS ALLEGEDLY FOUND LEAKAGE, AND THE BLUE LUMEN WAS VISUALLY INSPECTED AND ALSO FOUND TO BE DAMAGED AT THIS TIME. IT WAS FURTHER REPORTED THAT THE LUMEN WAS ALLEGEDLY FOUND SLITS NEAR THE HUB ON TWO OF THE LUMENS AND THE BLOOD FOUND TO BE BLEED BACK THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22000301 ↗

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