BardPort 0602190Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741025549), received between Dec 21, 2018 and Mar 13, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 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 24589159 ↗
• InjuryDec 17, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23825504 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22989832 ↗
• InjuryJul 11, 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 IS UNKNOWN.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 22477702 ↗
• InjuryOct 3, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT IT WAS LOCATED IN THE RIGHT VENTRICLE OF THE HEART AND PHYSICIAN REMOVED THE RESERVOIR ON THE LEFT CHEST WALL AND ACCESSED THE RIGHT JUGULAR VEIN TO PLACE A NEW PORT AND TO RETRIEVE THE FRACTURED PIECE. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20357083 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE BLOOD CULTURE TEST RESULTED POSITIVE FOR STAPH INFECTION AND THE PATIENT ALLEGEDLY DEVELOPED WITH BLOOD GROWING SEPSIS SECONDARY TO BACTERIAL INFECTION AS A RESULT OF THE DEFECTIVE INFECTED CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 19804233 ↗
• InjuryJun 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SEVEN YEARS FIVE MONTHS AND THREE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH BACTERIAL INFECTION AND THROMBOSIS. IT WAS FURTHER REPORTED THAT PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 19590801 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE YEAR, ONE MONTH AND TWENTY-SIX DAYS POST PORT PLACEMENT IN THE LEFT SUBCLAVIAN VEIN, THE PATIENT WAS ALLEGEDLY EXPERIENCED WITH PORT SITE INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED WITH SEPSIS. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17921089 ↗
• MalfunctionJun 19, 2023Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Entrapment of Device; Fracture; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AND ONE MONTH POST-PORT PLACEMENT, THE PORT ALLEGEDLY BROKE AWAY FROM THE CATHETER DURING THE ATTEMPT TO REMOVE THE DEVICE. IT WAS FURTHER REPORTED THAT THE PORT WAS EASILY DISSECTED FREE OF THE CAPSULE. IT WAS ALSO REPORTED THAT THE CATHETER WAS ALLEGEDLY FIXED AT THE SUBCLAVIAN VEIN ENTRY SITE AND WAS DISSECTED FREE OF SURROUNDING TISSUE DOWN TO THE VEIN UNDER THE CLAVICLE. HOWEVER, THE EXTERNAL ASPECT OF THE CATHETER WAS NOTED TO BE CHANGED FROM SMOOTH TO TEXTURED, LIKELY RELATED TO CALCIFICATIONS, ADHESION, OR INGROWTH WITHIN THE VEIN. REPORTEDLY, THE CATHETER WAS UNABLE TO BE PULLED OUT WITH VEIN TENTING UPON TRACTION, AND IT WAS DECIDED TO LEAVE THE INTERNAL CATHETER IN PLACE DUE TO THE RISK OF VEIN INJURY OR HEMORRHAGE. THE EXTERNAL CATHETER AND THE SUBCUTANEOUS PORT WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150483 ↗
• MalfunctionJul 1, 2021Fracture; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY FRAYED AND LODGED IN THE INTRODUCER NEEDLE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DIFFICULT TO BE ADVANCED OR REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097871 ↗
• InjuryJun 1, 2021Fracture; Material Separation; Material Protrusion/Extrusion; Migration; Fracture; Material Separation; Material Protrusion/Extrusion; Migration

  IT WAS REPORTED THAT AFTER THE PORT PLACEMENT, THE LINE WAS ALLEGEDLY DISLODGED FROM THE HUB AND THE DEVICE ALLEGEDLY MIGRATED. IT WAS FURTHER REPORTED THAT A SEPARATE PROCEDURE WAS USED TO REMOVE THE LINE FROM INSIDE RIGHT ATRIUM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11911292 ↗
• MalfunctionOct 26, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0602190 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED MIGRATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) PATIENT WEIGHS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737913 ↗
• MalfunctionJul 16, 2020Backflow; Backflow

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602190 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED BACK FLOW. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT IS A 12 YEAR OLD FEMALE WITH 46 KG'S OF WEIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10284701 ↗
• MalfunctionJul 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602190 PORT ALLEGEDLY LEAKED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS (B)(6) MALE AND WEIGHED (B)(6) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283652 ↗
• MalfunctionJan 15, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 602190 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9592513 ↗
• MalfunctionApr 18, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 602190 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED HAVING FOREIGN MATERIAL PRESENT IN DEVICE. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS A 24-YEAR-OLD MALE WITH NO WEIGHT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529867 ↗
• InjuryDec 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THERE WAS ALLEGEDLY SKIN EROSION AND THE PORT WAS REMOVED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 8190871 ↗