BardPort M.R.I. 0604580Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00801741025877), received between May 9, 2018 and Jan 22, 2026 — classified as 16 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2025 A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING M.R.I. HARD BASE IMPLANTABLE PORT, THE LEFT INTERNAL JUGULAR VEIN WAS PUNCTURED AND A DILATOR WAS INTRODUCED. DURING THE PROCEDURE THE CATHETER WAS ALLEGEDLY FOUND NOT PASSING THROUGH THE DILATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143079 ↗
• InjurySep 3, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22950460 ↗
• MalfunctionAug 29, 2025Difficult to Insert; Suction Problem; Obstruction of Flow; Difficult to Insert; Suction Problem; Obstruction of Flow

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A PORT PLACEMENT PROCEDURE THROUGH THE SUBCLAVIAN REGION GUIDED BY ULTRASOUND. DURING THE PROCEDURE, IT WAS REPORTED THAT THE RESERVOIR ALLEGEDLY FOUND WITH NO RETURN WHILE CONNECTING TO THE CATHETER. IT WAS FURTHER REPORTED THAT THE RESERVOIR ALLEGEDLY FOUND TO BE OBSTRUCTED. THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920398 ↗
• InjuryFeb 3, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED AND LODGED IN THE PULMONARY ARTERY. REPORTEDLY, IT WAS REMOVED THROUGH HEMODYNAMICS AND CATHETER WAS REPLACED. HOWEVER, THE CURRENT OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 21292160 ↗
• MalfunctionNov 25, 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, THERE WAS ALLEGEDLY AN OBSTRUCTION OCCURRED IN THE CATHETER. IT WAS FURTHER REPORTED THERE WAS ALLEGEDLY AN ISSUE WITH INFUSION AND ASPIRATION. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769680 ↗
• MalfunctionAug 5, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING THE PREPARATION OF A PORT PLACEMENT PROCEDURE, THE PINK PUNCTURE NEEDLE WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT LEAKAGE ALLEGEDLY OCCURRED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905404 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS AND THIRTEEN DAYS POST A PORT PLACEMENT IN THE RIGHT AND LEFT MAIN BRANCHES OF THE PULMONARY ARTERY, THE CATHETER WAS ALLEGEDLY FOUND TO BE RUPTURED UNDER CHEST COMPUTED TOMOGRAPHY EXAMINATION. REPORTEDLY, THE CATHETER WAS EXCHANGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643784 ↗
• MalfunctionApr 5, 2024Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DILATOR WAS ALLEGEDLY CRUSHED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049403 ↗
• MalfunctionNov 13, 2023Fluid/Blood Leak; Fracture; Suction Problem; Fluid/Blood Leak; Fracture; Suction Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PUNCTURE NEEDLE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO ASPIRATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117912 ↗
• MalfunctionNov 13, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PINK PUNCTURE NEEDLE ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117890 ↗
• MalfunctionOct 19, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE NEEDLE ALLEGEDLY HAD A HOLE IN IT AND MADE THE PUNCTURE DIFFICULT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963318 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A FLUID LEAK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903222 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A FLUID LEAK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903187 ↗
• MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD FLUID LEAK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894615 ↗
• MalfunctionAug 31, 2023Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE NEEDLE OF THE DEVICE WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE INTRODUCER. IT WAS FURTHER REPORTED THAT WHEN THEY FORCED THE NEEDLE INTO THE INTRODUCER, THE NEEDLE ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660779 ↗
• InjuryJan 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO MONTHS AND FOURTEEN DAYS POST PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED EXTRAVASATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 16270320 ↗
• MalfunctionJan 31, 2023Fracture; Material Puncture/Hole; Suction Problem; Obstruction of Flow; Fracture; Material Puncture/Hole; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY HAD SUCTION ISSUE. IT WAS FURTHER REPORTED THAT THE PORT ALLEGEDLY HAD OBSTRUCTION OF FLOW. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270027 ↗
• InjuryNov 7, 2022Fracture; Material Separation; Dent in Material; Migration; Fracture; Material Separation; Dent in Material; Migration

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED AND SEPARATED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY MIGRATED INTO THE PULMONARY ARTERY. REPORTEDLY THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 15741943 ↗
• MalfunctionSep 30, 2022Fracture; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent; Fracture; Stretched; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, GUIDEWIRE ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518763 ↗
• MalfunctionSep 29, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CONNECTION BETWEEN THE CATHETER AND THE ROD ON THE TOP OF THE CHAMBER WAS ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507956 ↗
• InjuryAug 4, 2022Fracture; Material Separation; Dent in Material; Migration; Fracture; Material Separation; Dent in Material; Migration

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AND TEN MONTHS POST PORT PLACEMENT IN SUBCLAVIAN ARTERY, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE FRAGMENT EMBOLIZED TO THE PULMONARY ARTERY AND MAIN BRANCHES BILATERALLY. REPORTEDLY, CATHETER FRAGMENT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 15162210 ↗
• MalfunctionJun 22, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PLASTIC PART OF THE PUNCTURE NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14768671 ↗
• MalfunctionMay 23, 2022Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE AIR LEAKAGE FROM THE PLASTIC SYRINGE WAS ALLEGEDLY FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469797 ↗
• MalfunctionApr 28, 2022Difficult to Flush; Suction Problem; Obstruction of Flow; Deformation Due to Compressive Stress; Difficult to Flush; Suction Problem; Obstruction of Flow; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY SHOWED NO FLOW. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14235252 ↗
• MalfunctionDec 13, 2021Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD OBSTRUCTION OF FLOW AND DIFFICULT TO INFUSE. IT WAS FURTHER REPORTED THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982004 ↗