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Hickman 0600310Recalls & reported problems

Bard Access Systems, Inc. · Hickman 7 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
8
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741051739), received between Jan 10, 2020 and Jul 14, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

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

  • Detachment of Device or Device Component2
  • Fracture2
  • Stretched2
  • Adverse Event Without Identified Device or Use Problem1
  • Collapse1
  • Component Missing1
  • Contamination1
  • Defective Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient2
  • No Patient Involvement1
  • Sepsis1

Recent adverse event reports

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

  • MalfunctionJul 14, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

    IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE Y PIECE OF THE HUB ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12164625 ↗
  • MalfunctionMay 11, 2021Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

    IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE LUMEN OF THE DEVICE WAS ALLEGEDLY OCCLUDED AND AS A RESULT BLOOD WAS UNABLE TO BE ASPIRATED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11805206 ↗
  • MalfunctionFeb 24, 2021Material Discolored; Fracture; Stretched; Material Discolored; Fracture; Stretched

    IT WAS REPORTED THAT DURING FLUSHING THE WHITE LUMEN, A LITTLE BALLOON WAS NOTICED ON THE HUB THAT APPEARED PINK. IT WAS FURTHER REPORTED THAT RED LUMEN WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11371325 ↗
  • MalfunctionFeb 24, 2021Collapse; Contamination; Stretched; Material Protrusion/Extrusion; Collapse; Contamination; Stretched; Material Protrusion/Extrusion

    IT WAS REPORTED THAT DURING FLUSHING, THE LUMEN ALLEGEDLY COLLAPSED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11371308 ↗
  • InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THREE DAYS POST CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED CATHETER RELATED SEPSIS WITH STAPHYLOCOCCUS AUREUS. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

    Patient problems: Sepsis

    MAUDE report 11277641 ↗
  • MalfunctionJan 14, 2020Component Missing; Missing Information; Component Missing; Missing Information

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0600310 CHRONIC CATHETER EXPERIENCED MISSING COMPONENTS AND MISSING INFORMATION. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 9586867 ↗
  • MalfunctionJan 13, 2020Material Perforation; Material Perforation

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600310 CHRONIC CATHETER ALLEGEDLY EXPERIENCED MATERIAL PERFORATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9582945 ↗
  • MalfunctionJan 10, 2020Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600310 CHRONIC CATHETER EXPERIENCED DEFECTIVE COMPONENTS. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9578410 ↗

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