BardPort M.R.I. 0602660Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741025655), received between Aug 29, 2018 and Sep 30, 2026 — classified as 4 deaths, 18 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 38 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Fracture; Material Separation; Migration

  It was reported through the litigation process that approximately ten months and twelve days after port placement procedure; the port catheter fractured and migrated into the left main pulmonary artery. Reportedly, the port and fractured catheter was removed. It was further reported that patient was expired, and the cause of death was not provided.

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

  MAUDE report 50947129 ↗
• InjurySep 25, 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 an unspecified infection, sepsis and acute organ dysfunction. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50894480 ↗
• InjuryJun 1, 2026Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, LEAKAGE OF DYE INTO THE SHOULDER TISSUE WAS OBSERVED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25346303 ↗
• InjuryMay 28, 2026Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, LEAKAGE OF DYE INTO THE SHOULDER TISSUE WAS OBSERVED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25312629 ↗
• MalfunctionApr 14, 2026Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868151 ↗
• InjuryMar 26, 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24695904 ↗
• DeathMar 2, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH 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 24479065 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, A PORT MALFUNCTION OCCURRED AND THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24275986 ↗
• DeathDec 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND OCCLUSION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 23837143 ↗
• InjuryNov 26, 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 23655490 ↗
• MalfunctionOct 21, 2025Fracture; Fracture

  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 23345730 ↗
• InjurySep 5, 2025Adverse 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 DIAGNOSED WITH PLEURITIC CHEST PAIN, THROMBOSIS AND PULMONARY EMBOLISM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Chest Pain; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 22975132 ↗
• DeathAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER PORT PLACEMENT PROCEDURE, THE CATHETER HAD ALLEGEDLY FRACTURED. REPORTEDLY, THE PATIENT EXPIRED, AND THE CAUSE OF DEATH WAS NOT PROVIDED.

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

  MAUDE report 22724750 ↗
• InjuryJul 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 UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22636642 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455560 ↗
• InjuryApr 3, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21760228 ↗
• MalfunctionFeb 9, 2025Fracture; Material Separation; Deformation Due to Compressive Stress; Migration; Fracture; Material Separation; Deformation Due to Compressive Stress; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER FRACTURED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341202 ↗
• MalfunctionNov 30, 2024Difficult to Flush; Suction Problem; Obstruction of Flow; Difficult to Flush; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED SWELLING AT CHEST POCKET. IT WAS FURTHER REPORTED THAT THE PORT WAS ALLEGEDLY UNABLE TO BE ASPIRATED AND INFUSED AND THE PORT ALLEGEDLY HAD A BLOCKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Swelling/ Edema

  MAUDE report 20813659 ↗
• InjuryNov 21, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT PROCEDURE, THE PORT CATHETER WAS ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED WITH SUPERIOR VENA CAVA SYNDROME. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 20744648 ↗
• InjuryNov 18, 2024Adverse 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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20705994 ↗
• InjuryOct 7, 2024Fracture; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE THE GUIDEWIRE SMOOTHLY WENT INSIDE, BUT THE SHEATH ALLEGEDLY COULDN¿T BE PUSHED IN OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT ADDITIONALLY, INTERNAL JUGULAR VEIN WAS GETTING INJURED WHICH LED TO BLOOD LOSS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380664 ↗
• InjurySep 4, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY SIX MONTHS AND NINE DAYS LATER POST PORT PLACEMENT PROCEDURE FOR INTRAVENOUS ACCESS, THE PORT CATHETER ALLEGEDLY HAD FRACTURED. IT WAS FURTHER REPORTED THAT THE FRACTURED CATHETER MIGRATED INTO THE RIGHT VENTRICLE. REPORTEDLY, THE FRACTURED CATHETER AND THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE.

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

  MAUDE report 20134953 ↗
• InjuryAug 30, 2023Fracture; Material Separation; Suction Problem; Dent in Material; Deformation Due to Compressive Stress; Migration; Fracture; Material Separation; Suction Problem; Dent in Material; Deformation Due to Compressive Stress; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIMES, POST PORT PLACEMENT FOR CANCER TREATMENT, THE PORT ALLEGEDLY COMPRESSED, ERODED, AND PINCHED OFF. IT WAS FURTHER REPORTED THAT THE PHYSICIANS WERE UNABLE TO DRAW BACK FROM THE PORT DURING THE INFUSION. FURTHERMORE, AN X-RAY REVIEW SHOWED THAT A LARGE PIECE OF THE CATHETER MEASURING OVER FIVE CENTIMETERS HAD BROKEN AWAY AND LODGED IN THE PATIENT'S HEART. REPORTEDLY, THE PATIENT UNDERWENT AN EMERGENCY HEART CATHETERIZATION TO RETRIEVE THE CATHETER SEGMENT FROM THE HEART AND WILL UNDERGO SURGERY TO REMOVE THOSE PORTIONS OF THE DEVICE THAT REMAIN IMPLANTED; HOWEVER, THE CURRENT STATUS OF THE PATENT IS UNKNOWN.

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

  MAUDE report 17648960 ↗
• InjuryJul 10, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY BROKE AND TWO PIECES WERE MIGRATED TO HEART AND ONE PIECE WAS MIGRATED TO LIVER. REPORTEDLY, SURGERY WAS PERFORMED TO REMOVE THE PARTS. PORT SYSTEM WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 17285600 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD PUNCTURE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY LEAKED WHILE FLUSHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501629 ↗