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BardPort 0602180Recalls & reported problems

Bard Access Systems, Inc. · BardPort Titanium Low-Profile Implantable Port with Pre-Attached 6.6F Open-Ended Single-Lumen Venous Catheter · Class 2 · Implant

All models of BardPort (13)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741025532), received between Aug 19, 2019 and Jun 20, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Disconnection” (1 report).

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: 0 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: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 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

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Disconnection1
  • Fluid/Blood Leak1
  • Fracture1
  • Material Separation1
  • Migration1

Patient problems

  • Unspecified Infection2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Extravasation1
  • Pain1
  • Swelling1
  • Thrombosis/Thrombus1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE PATIENT DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 22296311 ↗
  • InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 21352612 ↗
  • InjuryJul 12, 2021Disconnection; Fracture; Material Separation; Migration; Disconnection; Fracture; Material Separation; Migration

    IT WAS REPORTED THAT DURING A PORT REMOVAL PROCEDURE THE CATHETER ALLEGEDLY FRACTURED FROM THE PORT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY MIGRATED TO THE PULMONARY ARTERY. REPORTEDLY, THE DEVICE WAS REMOVED. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12148509 ↗
  • InjuryAug 19, 2019Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT APPROXIMATELY FIVE YEARS POST PLACEMENT OF THE PORT CATHETER VIA THE RIGHT FACIAL VEIN, DURING HOME INFUSION OF SALINE, BENEFIX AND HEPARIN THE PORT WAS ALLEGEDLY LEAKING EXTERNALLY. REPORTEDLY, THE HEALTH CARE PROVIDER ADMINISTERED TISSUE PLASMINOGEN ACTIVATOR (TPA). IT WAS FURTHER REPORTED THAT WHILE PERFORMING THE DYE STUDY, THE PATIENT EXPERIENCED PAIN AND SWELLING AT THE PORT SITE AS THE CONTRAST MEDIUM LEAKED THROUGH THE SILICONE SEPTUM OF THE PORT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY. THE PATIENT WAS REPORTEDLY STABLE AFTER THE REMOVAL AND REPLACEMENT OF THE DEVICE.

    Patient problems: Extravasation; Pain; Swelling

    MAUDE report 8907622 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

All PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices →

Sources and updates

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