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
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
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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