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Hickman 0600564Recalls & reported problems

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

All models of Hickman (28)

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

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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741051852), received between Feb 17, 2017 and Jul 4, 2021 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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

Device problems

  • Fluid/Blood Leak2
  • Crack1
  • Defective Component1
  • Fracture1
  • Suction Problem1

Patient problems

  • No Consequences Or Impact To Patient2
  • Death1
  • Diaphoresis1
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1
  • Numbness1
  • Stroke/CVA1
  • Weakness1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 4, 2021Suction Problem; Suction Problem

    IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY FAILED TO ASPIRATE BLOOD. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12114685 ↗
  • MalfunctionJan 14, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL 0600564 CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE. WEIGHT WAS NOT PROVIDED FOR THE REPORTED PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9586486 ↗
  • MalfunctionOct 16, 2019Defective Component; Defective Component

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600564 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A FEMALE WHOSE AGE AND WEIGHT WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9200120 ↗
  • MalfunctionNov 22, 2017Fluid/Blood Leak

    THE FACILITY REPORTED TO THE SALES REP THAT THE PHYSICIAN FLUSHED THE HICKMAN CATHETER AT THE END OF THE PROCEDURE AND NOTICED IT TO BE LEAKING. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7054228 ↗
  • DeathFeb 17, 2017Crack

    PER MEDWATCH REPORT, THE FACILITY REPORTED THAT THE PATIENT PRESENTED WITH A CRACKED HICKMAN CATHETER, WHICH WAS INITIALLY PLACED APPROXIMATELY FIFTEEN MONTHS AGO. IT WAS STATED THAT AFTER THE CATHETER WAS REPLACED, THE PATIENT APPEARED TO BE DIAPHORETIC WITH LEFT SIDED NUMBNESS/WEAKNESS, AND A NOTICEABLE FACIAL DROOP. THE STROKE TEAM WAS NOTIFIED. IT WAS STATED THAT THE PATIENT SUFFERED AN ACUTE STROKE. THE PATIENT EXPIRED FOUR DAYS LATER.

    Patient problems: Death; Diaphoresis; Numbness; Stroke/CVA; Weakness

    MAUDE report 6341333 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources and updates

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