BardPort M.R.I. 0604550Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741025860), received between Dec 21, 2018 and Mar 6, 2026 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24528310 ↗
• 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 SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22587114 ↗
• InjuryJun 19, 2025Device Appears to Trigger Rejection; Adverse 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 WAS ALLEGEDLY DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22291602 ↗
• MalfunctionFeb 27, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  ON (B)(6) 2025, A PATIENT UNDERWENT THE PORT PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING A PREPARATION OF PORT PLACEMENT, WHEN OPENED THE PACKAGE AN EYELASH AND HAIR WAS ALLEGEDLY FOUND. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21476745 ↗
• MalfunctionMay 9, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ONE WEEK AND THREE DAYS POST PORT PLACEMENT, THE TIP OF THE CATHETER WAS ALLEGEDLY FOUND SPLIT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED SUBCUTANEOUSLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893517 ↗
• InjuryJul 2, 2021Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST PORT PLACEMENT, THE PORT ALLEGEDLY FRACTURED AND MIGRATED. IT WAS FURTHER REPORTED THAT ADDITIONAL SURGERY WAS PERFORMED. PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 12106276 ↗
• MalfunctionJun 8, 2021Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE NEEDLE WAS ALLEGEDLY HAD LEAKAGE. IT WAS FURTHER REPORTED THE PATIENT WAS UNABLE TO ASPIRATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953884 ↗
• MalfunctionFeb 16, 2021Fracture; Leak/Splash; Air/Gas in Device; Fracture; Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE SYRINGE PLUNGER ALLEGEDLY HAD AIR LEAK DURING ASPIRATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331608 ↗
• MalfunctionApr 14, 2020Break; Difficult to Insert; Break; Difficult to Insert

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0604550 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED DIFFICULT TO INSERT AND BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959680 ↗
• MalfunctionJan 15, 2020Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0604550. IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS FEMALE, AND THE WEIGHT IS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594154 ↗
• MalfunctionDec 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER ALLEGEDLY FOUND A PLASTIC RING ON THE DILATOR COMPONENT. IT WAS FURTHER REPORTED THAT THE PLASTIC RING WAS REMOVED PRIOR TO IMPLANTED THE PORT DEVICE. REPORTEDLY, ANOTHER PEEL-AWAY SHEATH WAS USED IN THE COMPLETION OF THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189389 ↗