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Hickman 0600350Recalls & reported problems

Bard Access Systems, Inc. · Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray 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.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741051777), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

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

  • Fluid/Blood Leak1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE CATHETER BALLOONED, BUT DID NOT RUPTURE. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7830646 ↗

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

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

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