BardPort M.R.I. 6603880Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741027413), received between Jun 28, 2018 and Aug 26, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892563 ↗
• MalfunctionJul 25, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607496 ↗
• MalfunctionDec 27, 2024Loss of or Failure to Bond; Fracture; Material Separation; Fitting Problem; Detachment of Device or Device Component; Loss of or Failure to Bond; Fracture; Material Separation; Fitting Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE VALVE CUFF ON THE PORT WAS ALLEGEDLY BROKEN AND GOT SEPARATED. REPORTEDLY, IT COULD NOT BE REATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025364 ↗
• InjuryJan 19, 2022Fluid/Blood Leak; Difficult to Flush; Material Puncture/Hole; Suction Problem; Migration; Fluid/Blood Leak; Difficult to Flush; Material Puncture/Hole; Suction Problem; Migration

  IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF "BURDEN OF COMPLICATIONS FROM NEEDLE PENETRATION OF PLASTIC PORTS IN CHILDREN", THAT THE PORT ALLEGEDLY HAD EIGHT OCCURRENCES OF POSTERIOR PORT PERFORATION AND ONE OCCURRENCES OF LEAK, DIFFICULT TO FLUSH, SUCTION ISSUE AND MIGRATION WAS NOTED. THE PATIENT REPORTEDLY EXPERIENCED PAIN AND DIAGNOSED WITH EXTRAVASATION AND INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Pain; Unspecified Infection

  MAUDE report 13289567 ↗
• MalfunctionOct 27, 2020Fracture; Suction Problem; Fracture; Suction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 6603880 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED FRACTURE AND SUCTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744568 ↗
• InjuryDec 12, 2019Fracture; Deformation Due to Compressive Stress; Material Twisted/Bent; Fracture; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT PROCEDURE THE GUIDEWIRE WAS ALLEGEDLY DAMAGED. THE GUIDEWIRE DAMAGED ALLEGEDLY RESULTED IN BLOOD LOSS, REQUIRING A TRANSFUSION. REPORTEDLY ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 9459203 ↗
• InjuryAug 15, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT DEVICE IMPLANT, THE PORT CATHETER ALLEGEDLY RUPTURED WITH DISTAL FRAGMENT MIGRATION TO RIGHT CAVITIES. IT WAS FURTHER REPORTED THAT THE MIGRATED CATHETER WAS RETRIEVED VIA SNARE. IT WAS FURTHER REPORTED THAT ANOTHER PORT DEVICE WAS IMPLANTED. REPORTEDLY, THE PATIENT IS RESUMING CHEMOTHERAPY INFUSIONS.

  Patient problems: Injury; Swelling

  MAUDE report 8898013 ↗
• MalfunctionAug 29, 2018Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  DURING DECONTAMINATION OF THE DEVICE, THERE WERE HOLES FOUND ON THE BOTTOM SIDE OF THE PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7830845 ↗
• MalfunctionJun 28, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PORT BECAME DISCONNECTED WITH PERFORATIONS AT THE BASE CAUSING LEAKAGE. THE DEVICE WAS REPORTEDLY REMOVED. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7648524 ↗