BardPort M.R.I., ChronoFlex 0605450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741025945), received between Jan 21, 2021 and Jul 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY RUPTURED AND LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210847 ↗
• MalfunctionJul 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY THREE YEAR SIX MONTHS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097870 ↗
• MalfunctionJan 21, 2021Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0605450 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FRACTURE AND DEFORMATION DUE TO COMPRESSIVE STRESS. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11211147 ↗