BardPort M.R.I. 0602680Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00801741025679), received between Jul 7, 2017 and Sep 25, 2026 — classified as 2 deaths, 54 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Fracture” (91 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 179 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 21, 2026Difficult to Flush; Suction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING AN M.R.I IMPLANTABLE PORT. IT WAS REPORTED THAT POST IMPLANTATION, THE PORT INTERMITTENTLY FAILED IN BOTH ASPIRATION AND INFUSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934273 ↗
• MalfunctionApr 17, 2026Component Missing; Missing Information

  THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE INVOLVING A BARD MR-COMPATIBLE PORT. IT WAS REPORTED THAT THE PORTS WERE SUPPLIED ONLY IN BLISTER PACKS WITHOUT THE OUTER BOX. AS A RESULT, IMPORTANT PATIENT ID STICKERS WERE MISSING FROM THE PORT PACK TRAY, AND THERE WAS NO ABILITY TO MARK THE PLACEMENT AND FINAL POSITION OF THE CATHETER TIP. CONSEQUENTLY, PATIENT INFORMATION AND CLINICAL RECORDS MAY BE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907218 ↗
• MalfunctionApr 17, 2026Component Missing; Missing Information

  THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE INVOLVING A BARD MR-COMPATIBLE PORT. IT WAS REPORTED THAT THE PORTS WERE SUPPLIED ONLY IN BLISTER PACKS WITHOUT THE OUTER BOX. AS A RESULT, IMPORTANT PATIENT ID STICKERS WERE MISSING FROM THE PORT PACK TRAY, AND THERE WAS NO ABILITY TO MARK THE PLACEMENT AND FINAL POSITION OF THE CATHETER TIP. CONSEQUENTLY, PATIENT INFORMATION AND CLINICAL RECORDS MAY BE COMPROMISED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907215 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2018, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE VIA THE LEFT SUBCLAVIAN VEIN FOR COLON CANCER AND LEVO SCLEROSIS CHEMOTHERAPY. APPROXIMATELY ONE YEAR, EIGHT MONTHS AND EIGHTEEN DAYS LATER, ON (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH A DEEP VEIN THROMBOSIS AND SUPERIOR VENA CAVA (SVC) SYNDROME. SUBSEQUENTLY, ON (B)(6) 2021, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24739244 ↗
• MalfunctionMar 30, 2026Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE M.R.I IMPLANTABLE PORT, HICKMAN SINGLE LUMEN. POST PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS KINKING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725722 ↗
• MalfunctionMar 25, 2026Fracture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING M.R.I IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F. DURING THE PROCEDURE, THE DEVICE BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686027 ↗
• InjuryMar 16, 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24602923 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH 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 24602712 ↗
• InjuryMar 5, 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24519009 ↗
• InjuryFeb 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 AN UNSPECIFIED INFECTION ACCOMPANIED BY SWELLING, SEVERE PAIN, FLUID ACCUMULATION, AND A SMALL SEROMA TYPE CAVITY AT THE PORT SITE. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain; Seroma; Swelling/ Edema; Unspecified Infection

  MAUDE report 24280485 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak; Fracture

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING AN M.R.I. PORT. PRIOR TO THE PROCEDURE, DURING PREPARATION, IT WAS REPORTED THAT UPON OPENING THE CATHETER PACKAGE, IT WAS FOUND THAT THE CATHETER TIP WAS ALLEGEDLY FRACTURED. FURTHERMORE, THE ASSOCIATED NEEDLE WAS LEAKING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244208 ↗
• InjuryJan 30, 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 24223330 ↗
• DeathJan 8, 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24000514 ↗
• MalfunctionDec 22, 2025Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING M.R.I PORT. DURING THE PREPARATION OF THE PROCEDURE, THE DEVICE WAS FOUND TO BE DEFECTIVE AS THE NEEDLE WAS BROKEN, AND DURING ASPIRATION AIR WAS GETTING FILLED IN THE SYRINGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861554 ↗
• InjuryDec 13, 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: Thrombosis/Thrombus

  MAUDE report 23797179 ↗
• InjuryDec 13, 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, THE PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23797162 ↗