BardPort, ChronoFlex 0607301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741026126), received between Jan 21, 2021 and Feb 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE CATHETER TIP ALLEGEDLY COMPRESSED FLAT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ALLEGEDLY HAD TO CUT THE COMPRESSED CATHETER TIP TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384592 ↗
• MalfunctionJan 21, 2021Nonstandard Device; Obstruction of Flow; Component Misassembled; Nonstandard Device; Obstruction of Flow; Component Misassembled

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0607301 PORT SYSTEM ALLEGEDLY EXPERIENCED OBSTRUCTION OF FLOW, COMPONENT MISASSEMBLED AND NONSTANDARD DEVICE THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11211323 ↗