BardPort M.R.I., ChronoFlex 0605420Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741025921), received between Jul 27, 2018 and Sep 1, 2026 — classified as 1 death, 18 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 25 most recent of 33 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TWO YEARS, SIX MONTHS AND TWENTY-FIVE DAYS LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED INFECTION, BACTEREMIA, SEPSIS AND ORGAN DYSFUNCTION. THE PORT WAS REMOVED AND WAS REPLACED WITH A NEW DEVICE. LATER THE PATIENT PASSED AWAY AND CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Bacteremia; Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 22587026 ↗
• MalfunctionJun 30, 2025Fracture; Material Separation; Fracture; Material Separation

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE MRI CHRONO PORT. DURING THE PROCEDURE WHILE INSERTION, THE STEM OF THE CHEMO PORT ALLEGEDLY RUPTURED WHILE ATTACHING THE CATHETER TO THE PORT CHAMBER. THE CHEMO PORT HAD TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355781 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, ON (B)(6) 2013, A PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN INTRAVENOUS ACCESS. APPROXIMATELY TWO YEARS, FOUR MONTHS AND TWENTY SIX DAYS LATER, ON (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALSO DIAGNOSED WITH SEPSIS SECONDARY TO ENDOCARDITIS. SUBSEQUENTLY, ON (B)(6) 2016, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Endocarditis; Sepsis; Unspecified Infection

  MAUDE report 22334739 ↗
• InjuryMay 13, 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: Drug Resistant Bacterial Infection; Embolism/Embolus; Erythema; Extravasation; Purulent Discharge; Sepsis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22011119 ↗
• InjuryApr 30, 2025Fluid/Blood Leak; Difficult to Flush; Blocked Connection; Fluid/Blood Leak; Difficult to Flush; Blocked Connection

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING MRI CHRONO PORT. SOMETIMES POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD FLUSHING ISSUE, AND THE PATIENT EXPERIENCED SWELLING AND EXTRAVASATION. REPORTEDLY, DIFFICULTY IN PIERCING THE MEMBRANE OF THE DEVICE WAS OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 21933212 ↗
• InjuryApr 30, 2025Difficult to Flush; Blocked Connection; Difficult to Flush; Blocked Connection

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING MRI CHRONO PORT. SOMETIME POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD FLUSHING ISSUE AND EXPERIENCED SWELLING. REPORTEDLY, DIFFICULTY IN PIERCING THE MEMBRANE OF THE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 21933211 ↗
• InjuryApr 1, 2025Fracture; Device Appears to Trigger Rejection; Fracture; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT PROCEDURE, THE PORT CATHETER FRACTURED. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS AND FIBRIN SHEATH FORMATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21737339 ↗
• InjuryJan 17, 2025Expulsion; Expulsion

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, EXTRUSION OF PORT THROUGH SUPERIOR VENA CAVA WAS NOTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21176498 ↗
• InjuryJan 17, 2025Expulsion; Expulsion

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, EXTRUSION OF PORT THROUGH SUPERIOR VENA CAVA WAS NOTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21176497 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES, POST PORT PLACEMENT FOR ADMINISTRATION OF CHEMOTHERAPY, THE PATIENT DEVELOPED WITH PULMONARY EMBOLISM. REPORTEDLY, THE PATIENT WAS PLACED ON CHRONIC ANTICOAGULATION MEDICATION AND MONITORED. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 17692927 ↗
• MalfunctionSep 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE INTRODUCER NEEDLE ALLEGEDLY BROKEN .THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493543 ↗
• MalfunctionSep 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY STICKED TO THE CHEMOPORT KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492921 ↗
• MalfunctionAug 2, 2021Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE PREPARATION OF PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD DIFFICULTIES IN FLUSH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257543 ↗