BardPort 0602230Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741025563), received between Jan 2, 2019 and Feb 3, 2026 — classified as 14 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY LEAKED AND SUBSEQUENTLY FRACTURED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243131 ↗
• MalfunctionDec 9, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754789 ↗
• MalfunctionNov 21, 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 23614513 ↗
• InjuryNov 7, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23494549 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463664 ↗
• InjuryOct 21, 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 23345378 ↗
• InjuryAug 14, 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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22801619 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ELEVEN MONTHS AND EIGHT DAYS POST PORT PLACEMENT PROCEDURE FOR COLORECTAL CANCER CHEMOTHERAPY, THE PATIENT DEVELOPED WITH DEEP VEIN THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22517887 ↗
• InjuryJul 9, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2013, A PATIENT UNDERWENT PORT IMPLANTATION VIA THE RIGHT INTERNAL JUGULAR VEIN FOR THE TREATMENT OF B CELL LYMPHOMA. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SEPSIS. SUBSEQUENTLY, ON (B)(6) 2013, THE PORT WAS REMOVED DUE TO PORT INFECTION. IT WAS FURTHER REPORTED THAT PURULENT DISCHARGE WAS OBSERVED DURING THE REMOVAL. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Purulent Discharge; Sepsis; Unspecified Infection

  MAUDE report 22455555 ↗
• InjuryJun 4, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22138984 ↗
• InjuryFeb 14, 2025Disconnection; Fluid/Blood Leak; Fracture; Material Separation; Migration; Disconnection; Fluid/Blood Leak; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SIX MONTHS AND TWENTY-TWO DAYS POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY GOT SEPARATED FROM THE PORT CHAMBER. IT WAS FURTHER REPORTED THAT FLUID PASSING THROUGH THE SKIN AND THE CATHETER GOT MIGRATED FROM THE PORT CHAMBER WHICH HAS BEEN REMOVED WITH THE HELP OF SMEAR BY INTERVENTIONAL CARDIOLOGIST. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 21382680 ↗
• InjuryFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER FRACTURED. PATIENT HAD DEVELOPED WITH ARRHYTHMIAS AND CARDIAC ARREST. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Arrhythmia; Cardiac Arrest

  MAUDE report 21330740 ↗
• MalfunctionSep 30, 2024Fracture; Fracture; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY DEVELOPED WITH CATHETER FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 20333360 ↗
• InjurySep 22, 2024Fracture; Device Appears to Trigger Rejection; Material Separation; Migration; Fracture; Device Appears to Trigger Rejection; Material Separation; Migration

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

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

  MAUDE report 20275860 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT EIGHT YEARS, SEVEN MONTHS AND THIRTY DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED BACTEREMIA. REPORTEDLY, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 18562192 ↗
• MalfunctionSep 21, 2023Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PEEL AWAY SHEATH ALLEGEDLY GOT KINKED AND TARED INSIDE WHILE ADJUSTMENTS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788216 ↗
• InjuryFeb 12, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT ABOUT SEVEN YEARS POST PORT PLACEMENT FOR PURPOSES OF GAMMA GLOBULIN INJECTIONS, THE CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED WHEN THE PORT WAS REMOVED. IT WAS FURTHER REPORTED THAT THE FRAGMENT OF CATHETER MIGRATED AND LEFT IN ARTERY CAUSING TISSUE DAMAGE. FURTHERMORE, A COMPUTED TOMOGRAPHIC EXAMINATION CONFIRMED RETAINED CATHETER FRAGMENT ALONG THE POSTERIOR ASPECT OF THE UPPER SUPERIOR VENA CAVA. REPORTEDLY, THE PATIENT EXPERIENCED CHEST PAIN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Chest Pain; Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 16359850 ↗
• InjuryOct 10, 2022Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST PORT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN, THE CATHETER WAS ALLEGEDLY SEPARATED AND HAD BREAK. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD LEAKAGE AT PROXIMAL END. REPORTEDLY, PATIENT EXPERIENCED EXTRAVASATION. THE CURRENT STATUS OF THE PATIENT IS STABLE.

  Patient problems: Embolism/Embolus; Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571555 ↗
• MalfunctionSep 13, 2022Fluid/Blood Leak; Fracture; Suction Problem; Fluid/Blood Leak; Fracture; Suction Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD SUCTION ISSUE. IT WAS FURTHER REPORTED THAT FEW SOLUTION THAT THE SYRINGE HAS COMES OUT THROUGH THE CONNECTION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409117 ↗
• MalfunctionJun 17, 2022Fracture; Stretched; Failure to Advance; Physical Resistance/Sticking; Fracture; Stretched; Failure to Advance; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14726957 ↗
• MalfunctionFeb 3, 2022Fracture; Material Puncture/Hole; Air/Gas in Device; Fracture; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED UNSPECIFIED BD LUTONIX¿ CATHETER HAD A HOLE IN THE NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PERFORMING THE PUNCTURE, IT WAS DETECTED PRESENCE OF AIR IN THE SYRINGE IN SEVERAL OCCASIONS WITHOUT ACHIEVING THE PUNCTURE PROPERLY. THEREFORE, IT WAS PERFORMED A REVIEW OF THE PUNCTURE NEEDLE AND THE SYRINGE, AND IT WAS FOUND THE NEEDLE WAS BROKEN IN ITS BASE WHICH REPRESENTED THE AIR LEAKAGE TO THE SYRINGE."

  Patient problems: Bruise/Contusion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441231 ↗
• MalfunctionMar 31, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PORT PLACEMENT, THE HUB OF THE INTRODUCER NEEDLE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595597 ↗
• MalfunctionJan 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE PORT KIT ALLEGEDLY MISSED CARD. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153116 ↗
• InjuryOct 20, 2020Fracture; Material Separation; Suction Problem; Detachment of Device or Device Component; Migration; Fracture; Material Separation; Suction Problem; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, A PART OF THE DEVICE WAS FOUND TO BE DETACHED AND MIGRATED INTO THE HEART. THE MIGRATED SEGMENT WAS RECOVERED. THE CURRENT PATIENTS STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 10703658 ↗
• MalfunctionOct 17, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602230 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FOREIGN MATERIAL ON THE DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205652 ↗