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Hickman 0606460Recalls & reported problems

Bard Access Systems, Inc. · Hickman 10F Triple-Lumen CV Catheter with SureCuff Tissue Ingrowth Cuff · Class 2 · Implant

All models of Hickman (28)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741052002), received between May 18, 2018 and Apr 16, 2021 — classified as 3 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
  • Break1
  • Burst Container or Vessel1
  • Fracture1
  • Suction Problem1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 16, 2021Fluid/Blood Leak; Fracture; Suction Problem; Fluid/Blood Leak; Fracture; Suction Problem

    IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED ON SLEEVE AT WHICH THE 3 LUMENS WERE SEPARATED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED OVER THE FRACTURE AND FAILED TO ASPIRATE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11676727 ↗
  • MalfunctionMay 22, 2018Break; Burst Container or Vessel; Break; Burst Container or Vessel

    IT WAS REPORTED THAT THE CATHETER HAS AN ALLEGED SPLIT THAT WAS FOUND DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7535742 ↗
  • MalfunctionMay 18, 2018Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE CATHETER HAS AN ALLEGED SPLIT THAT WAS NOTED DURING USE, WHILE PATIENT WAS RECEIVING IV THERAPY. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7526314 ↗

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Sources and updates

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