BardPort, ChronoFlex 0605320Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741025907), received between Nov 20, 2018 and Dec 24, 2025 — classified as 1 death, 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23886373 ↗
• DeathDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION. REPORTEDLY THE PATIENT EXPIRED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23786844 ↗
• InjuryNov 26, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH THROMBOSIS AND OCCLUSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 23655500 ↗
• MalfunctionOct 15, 2025Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY MIGRATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298904 ↗
• InjuryMay 16, 2025Device Appears to Trigger Rejection; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22033295 ↗
• InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED WITH SEPSIS AS A RESULT OF THE DEFECTIVE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 19736712 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY SIX MONTHS AND EIGHT DAYS POST PORT PLACEMENT PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF SEPSIS AND ACUTE ENCEPHALOPATHY. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND THE DEVICE WAS REMOVED. THE STUDY WAS WITHDRAWAL DUE TO THE SUBJECT WAS EXPIRED. THE PRIMARY CAUSE OF THE DEATH WAS LUNG CANCER AND THE DEATH WAS NOT RELATED TO THE STUDY DEVICE AND PROCEDURE.

  Patient problems: Encephalopathy; Sepsis

  MAUDE report 18786919 ↗
• MalfunctionMay 16, 2023Material Discolored; Difficult to Remove; Material Discolored; Difficult to Remove

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT, CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS SUTURED TO THE VESSEL AND LEFT IT IN THE PATIENT BODY DUE TO THE RESISTANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937360 ↗
• MalfunctionJan 13, 2023Fracture; Suction Problem; Fracture; Suction Problem

  IT WAS REPORTED THAT TEN DAYS POST PORT PLACEMENT PROCEDURE VIA LEFT SUBCLAVIAN, THE PUNCTURE NEEDLE WAS ALLEGEDLY NOT VACUUMING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16155784 ↗
• MalfunctionJul 16, 2020Fluid/Blood Leak; Migration or Expulsion of Device; Detachment of Device or Device Component; Fluid/Blood Leak; Migration or Expulsion of Device; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0605320 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE AND LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD FEMALE IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286360 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT THE PORT DEVICE WAS ALLEGEDLY LEAKING. IT WAS FURTHER REPORTED THAT THE PORT DEVICE WAS REMOVED AND UPON REMOVAL, A ONE CENTIMETER GAP WAS FOUND ON THE TUBING OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090092 ↗