BardPort M.R.I.Recalls & reported problems across all models

We found 18 models of BardPort M.R.I. by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 421 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 30, 2026 — classified as 6 deaths, 151 injuries, 264 malfunctions.

The most frequently reported specific device problem is “Fracture” (172 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BardPort M.R.I. problems

BardPort M.R.I. models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BardPort M.R.I. 0602680

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 deaths179 reports
• BardPort M.R.I. 0603880

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  78 reports
• BardPort M.R.I. 0604580

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  64 reports
• BardPort M.R.I. 0602660

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 deaths38 reports
• BardPort M.R.I. 0602690

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  12 reports
• BardPort M.R.I. 0604550

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  11 reports
• BardPort M.R.I. 6603880

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  9 reports
• BardPort M.R.I. 0607100

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  8 reports
• BardPort M.R.I. 0603840

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  7 reports
• BardPort M.R.I. 0602670

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 reports
• BardPort M.R.I. 0602610

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• BardPort M.R.I. 0602620

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BardPort M.R.I. 0602650

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BardPort M.R.I. 0603500

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BardPort M.R.I. 0605930

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BardPort M.R.I. 0607174

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BardPort M.R.I. 0607200

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BardPort M.R.I. 6604550

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report

Recent BardPort M.R.I. adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 25, 2026Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured. However, there was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894488 ↗
• 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 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak; Suction Problem; Air/Gas in Device

  On (b)(6) 2026, a patient underwent a port placement procedure using an M.R.I. Port device. During the procedure, saline was observed leaking from the 10 mL syringe connected to the introducer needle. As a result, air entered the system, preventing aspiration. The procedure was subsequently completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750645 ↗
• InjuryAug 27, 2026Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Migration

  It was reported that twenty two years, two months and twenty three days old female patient underwent a port placement procedure using a M.R.I Port for the treatment of Stage II Hodgkin¿s lymphoma. On (b)(6) 2026, During the heparinization procedure, the patient developed severe pain. A chest X ray revealed a Port O Cath catheter fracture with embolization into the right atrium. The patient was subsequently scheduled for percutaneous removal of the intravascular foreign body and removal of the right subclavian vein Port O Cath via open anterior thoracic surgery. The removal procedure was reported to be very difficult. An attempt to capture the fractured catheter using a 6 Fr multilobed snare was unsuccessful. The catheter was subsequently captured and removed using a 6 Fr single-lobed snare catheter. Current status of the patient is reported to be stable.

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

  MAUDE report 50467574 ↗
• InjuryAug 14, 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 an unspecified infection. However, the current status of the patient was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50251854 ↗
• InjuryAug 12, 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 is unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50219022 ↗
• InjuryAug 5, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with supraventricular tachycardia, acute chest pain, thrombosis and coronary artery disease. However, the current status of the patient was unknown.

  Patient problems: Chest Pain; Tachycardia; Thrombosis/Thrombus

  MAUDE report 50137962 ↗
• MalfunctionAug 3, 2026Fracture; Material Separation; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113902 ↗
• MalfunctionAug 3, 2026Difficult to Remove; Failure to Advance

  On (b)(6)2026, a patient underwent a port placement procedure using an M.R.I. Port. During the procedure, a defect was identified in the needle, preventing it from moving in either direction. The needle could neither advance nor retract. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112403 ↗
• MalfunctionJun 2, 2026Fracture; Material Separation

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I IMPLANTABLE PORT. AFTER SOMETIMES, A BREAK WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25357008 ↗
• 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 ↗
• InjuryMay 21, 2026Device Appears to Trigger Rejection

  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 REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25239277 ↗
• MalfunctionMay 7, 2026Fracture; Material Separation; Stretched; Unraveled Material; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE M.R.I. IMPLANTABLE PORT. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT WHEN THE SURGEON PICKED UP THE WIRE, IT WAS ALLEGEDLY OBSERVED TO BE COILED, BENT, AND BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110223 ↗

Other Bard Access Systems, Inc. products

• Port Access Needle122 models · 3,744 reports · 3 recalls
• Groshong NXT ClearVue Catheter8 models · 3,266 reports
• PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports