BardPort 0602870Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741025778), received between Sep 26, 2018 and Jun 26, 2026 — classified as 1 death, 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2006, A PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN USING A BARDPORT TITANIUM DOME IMPLANTABLE PORT FOR THE TREATMENT OF CROHNS DISEASE. APPROXIMATELY ONE YEAR, EIGHT MONTHS, AND TWENTY NINE DAYS LATER, ON (B)(6) 2007, THE PATIENT WAS DIAGNOSED WITH POSITIVE BLOOD CULTURES AND AN INFECTED PORT A CATH. SUBSEQUENTLY, ON (B)(6) 2007, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25632442 ↗
• DeathSep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP OF DEATH WITH THE DEVICE WAS UNKNOWN.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 20332078 ↗
• MalfunctionMar 5, 2024Fracture; Material Separation; Stretched; Material Deformation; Fracture; Material Separation; Stretched; Material Deformation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PROBLEM WAS ALLEGEDLY IDENTIFIED IN THE TEFLON TISSUE OF THE GUIDE WIRE WITH AN AREA OF EXPOSURE OF THE WIRE LINE. IT WAS FURTHER REPORTED THAT THE GUIDE WIRE WAS ALLEGEDLY DEFORMED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841655 ↗
• MalfunctionMar 5, 2024Stretched; Unraveled Material; Stretched; Unraveled Material

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY HAD A DEFECT AS IT CAME UNRAVELED WITH A DISASSEMBLED CORE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841243 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO YEARS, FOUR MONTHS AND FIVE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH SEPSIS. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 18010003 ↗
• MalfunctionOct 12, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, NO FLOW WAS ALLEGEDLY DETECTED IN THE CATHETER. REPORTEDLY, THE PORT WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921090 ↗
• MalfunctionMay 23, 2023Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, NEEDLE ALLEGEDLY DID NOT ASPIRATE. IT WAS FURTHER REPORTED THAT SERUM ALLEGEDLY CAME OUT THROUGH A HOLE ON THE SIDE OF THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982139 ↗
• MalfunctionDec 9, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY PLACED IMPROPERLY. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948261 ↗
• MalfunctionAug 6, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286061 ↗
• MalfunctionJul 16, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE THE DEVICE GUIDEWIRE ALLEGEDLY FAILED TO ADVANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12179125 ↗
• MalfunctionJul 16, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0602870 IMPLANTED PORT ALLEGEDLY EXPERIENCED SUCTION ISSUE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, GENDER AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286303 ↗
• MalfunctionJan 15, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602870 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A CRACK AND A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A FEMALE WHOSE WEIGHT AND AGE WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592510 ↗
• MalfunctionOct 17, 2019Material Frayed; Material Frayed

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602870 IMPLANTABLE PORT ALLEGEDLY FRAYED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS FEMALE AND AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205777 ↗
• MalfunctionOct 17, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602870. IMPLANTABLE PORT ALLEGEDLY HAD DEFECTIVE COMPONENT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS FEMALE; HOWEVER, AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205773 ↗
• MalfunctionApr 18, 2019Component Incompatible; Failure to Infuse; Component Incompatible; Failure to Infuse

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0602870 IMPLANTED PORT EXPERIENCED A COMPONENT INCOMPATIBILITY AND A FAILURE TO INFUSE. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS REPORTED AS A FEMALE WEIGHING (B)(6) KGS WHOSE AGE WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528530 ↗
• MalfunctionJan 28, 2019Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  IT WAS REPORTED THAT THE GUIDE WIRE ALLEGEDLY GOT STUCK AFTER THE GUIDE WIRE PASSED THROUGH THE NEEDLE AND DID NOT WITHDRAW OR ADVANCE ANY FURTHER. IT WAS FURTHER ALLEGED THAT THE GUIDE WIRE AND NEEDLE WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT AND IT WAS DEEMED NECESSARY TO USE ANOTHER KIT AND PUNCTURE THE CENTRAL VEIN OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8283564 ↗
• InjurySep 26, 2018Break; Break

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST PORT CATHETER IMPLANT VIA LEFT SUBCLAVIAN VEIN, THE DEVICE ALLEGEDLY BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7910649 ↗