BardPort M.R.I., ChronoFlexRecalls & reported problems across all models

We found 5 models of BardPort M.R.I., ChronoFlex by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2018 and Sep 1, 2026 — classified as 1 death, 29 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BardPort M.R.I., ChronoFlex problems

BardPort M.R.I., ChronoFlex models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BardPort M.R.I., ChronoFlex 0605640

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  47 reports
• BardPort M.R.I., ChronoFlex 0605420

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death33 reports
• BardPort M.R.I., ChronoFlex 0605450

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• BardPort M.R.I., ChronoFlex 0607173

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• BardPort M.R.I., ChronoFlex 0655640

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports

Recent BardPort M.R.I., ChronoFlex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathSep 1, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50543367 ↗
• InjuryAug 5, 2026Fracture; Material Separation; Migration

  In 2023, a patient underwent a port placement procedure using an M.R.I. Ultra Slim Port. Post the procedure on (b)(6) 2026, it was reported that the catheter had fractured at the catheter-to-port connection site. It was further reported that a catheter fragment had migrated toward the heart. The device was subsequently removed. The patient's current condition is reported as stable.

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

  MAUDE report 50137688 ↗
• MalfunctionMay 26, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274409 ↗
• InjuryMay 25, 2026Device Appears to Trigger Rejection

  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 WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 25270742 ↗
• MalfunctionFeb 24, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425630 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24399019 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH DEEP VEIN THROMBOSIS AND METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, RESULTING IN PORT MALFUNCTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Drug Resistant Bacterial Infection; Thrombosis/Thrombus

  MAUDE report 24275989 ↗
• MalfunctionJan 8, 2026Fracture

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

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

  MAUDE report 24000872 ↗
• InjuryJan 7, 2026Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23987276 ↗
• InjuryDec 8, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23736188 ↗
• MalfunctionNov 18, 2025Degraded; Entrapment of Device; Fracture; Difficult to Remove; Material Too Rigid or Stiff; Material Separation; Deformation Due to Compressive Stress; Material Deformation; Naturally Worn; Degraded; Entrapment of Device; Fracture; Difficult to Remove; Material Too Rigid or Stiff; Material Separation; Deformation Due to Compressive Stress; Material Deformation; Naturally Worn

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. ULTRA SLIMPORT ON SIX MONTHS AGO. ON (B)(6) 2025, POST THE PROCEDURE WHILE REMOVAL OF THE PORT FROM PATIENTS' BODY, THE CATHETER TENDS TO STICK TO THE VEIN WALL AND GETS STUCK. THIS CAUSES ISSUES FOR THE SURGEON TO REMOVE THE OLD PORT. THEY ALSO OBSERVED THE CATHETER MATERIAL SEEMED HARDER AND STIFFER THAN A NEW PORT CATHETER SUSPECTING CHANGE IN MATERIAL OVER TIME. NEED TO ACCESS THE FEMORAL SITE TO ACCESS THAT PART OF THE VEIN AND SLOWLY REMOVE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579520 ↗
• MalfunctionNov 14, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE CATHETER HAD ALLEGEDLY FRACTURED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552074 ↗
• InjurySep 10, 2025Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A M.R.I. ULTRA SLIMPORT PLACEMENT PROCEDURE, FOR AN UNKNOWN MEDICAL CONDITION. DURING THE PROCEDURE, IT WAS REPORTED THAT AIR WAS ENTERING THROUGH THE PINK NEEDLE. ADDITIONALLY, IT WAS REPORTED THAT EMBOLISM WAS OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 23013012 ↗
• InjuryAug 28, 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 DEVELOPED WITH BLOOD CLOTS AND UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22911114 ↗
• InjuryJul 29, 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 DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22642496 ↗

Other Bard Access Systems, Inc. products

• Port Access Needle122 models · 3,744 reports · 3 recalls
• Groshong NXT ClearVue Catheter8 models · 3,266 reports
• PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports