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Hickman 0600580Recalls & reported problems

Bard Access Systems, Inc. · Hickman 9 Fr Pediatric Length Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth · Class 2 · Implant

All models of Hickman (28)

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

Adverse event reports
8
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741051883), received between Dec 29, 2015 and Nov 4, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 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: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak3
  • Fracture3
  • Backflow1
  • Burst Container or Vessel1
  • Component Missing1
  • Difficult to Flush1
  • Failure to Advance1
  • Material Protrusion/Extrusion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Extravasation1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 4, 2025Fracture; Fracture

    ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN PEDIATRIC CV CATHETER. DURING THE PROCEDURE, ALLEGEDLY THERE WAS BREAKAGE IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23460688 ↗
  • MalfunctionJan 23, 2024Backflow; Burst Container or Vessel; Fracture; Stretched; Material Protrusion/Extrusion; Backflow; Burst Container or Vessel; Fracture; Stretched; Material Protrusion/Extrusion

    IT WAS REPORTED THAT SEVEN MONTHS AND SIXTEEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY FOUND TO BE BALLOONED APPROXIMATELY ONE MONTH POST PLACEMENT. IT WAS FURTHER REPORTED THAT BLOOD BACKFLOW ALLEGEDLY OCCURRED AT THE SMALL LUMEN. REPORTEDLY, A SMALL FRACTURE WAS ALLEGEDLY NOTICED WHILE FLUSHING. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18561907 ↗
  • MalfunctionJun 14, 2023Unclear Information; Unclear Information

    IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE LABEL DOES NOT ALLEGEDLY HAVE THE INFORMATION ABOUT FULL LENGTH OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17123762 ↗
  • InjuryJul 21, 2021Fluid/Blood Leak; Difficult to Flush; Fracture; Obstruction of Flow; Fluid/Blood Leak; Difficult to Flush; Fracture; Obstruction of Flow

    IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT CONTRAST MEDIUM ALLEGEDLY LEAKED. REPORTEDLY THERE WAS DIFFICULTY IN FLUSHING THE CATHETER AND THROMBUS AT THE TIP WAS OBSERVED. PATIENT EXPERIENCED EXTRAVASATION. PATIENT CURRENT STATUS WAS UNKNOWN.

    Patient problems: Extravasation

    MAUDE report 12201049 ↗
  • MalfunctionFeb 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11277691 ↗
  • MalfunctionApr 19, 2019Component Missing; Component Missing

    THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0600580 HICKMAN 9.0FR D/L PED EXPERIENCED A MISSING COMPONENT. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. NEITHER EVENT INVOLVED PATIENTS.

    Patient problems: No Patient Involvement

    MAUDE report 8533130 ↗
  • MalfunctionJun 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT WHEN FLUSHING THE LINE, PRIOR TO BLOOD DRAW, THE LUMEN PROXIMAL TO THE BIFURCATION HUB BURST. THE CATHETER WAS LATER REMOVED AND A NEW DEVICE WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7648816 ↗
  • MalfunctionDec 29, 2015Failure to Advance

    IT WAS REPORTED THAT THE SURGEON WAS ALLEGEDLY UNABLE TO ADVANCE THE GUIDE WIRE THROUGH THE NEEDLE. SURGEON ALLEGED THAT THE NEEDLE WAS BLOCKED. A NEW CATHETER SET WAS OPENED TO COMPLETE THE PROCEDURE. A NEW PUNCTURE WITH THE NEW NEEDLE WAS NECESSARY TO COMPLETE THE PROCEDURE. RETURNED SAMPLE SHOWS A GUIDEWIRE FRAY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5332449 ↗

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Sources and updates

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