BardPort, Groshong 0602850Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741025754), received between Aug 22, 2018 and Aug 14, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Fracture; Material Separation; Migration

  It was reported through the litigation process that, on (b)(6) 2020, the patient underwent a port placement using the BardPort Titanium Dome Implantable Port Catheter via right internal jugular for chemotherapy. About three years, three months and eight days later, on (b)(6) 2023, the catheter allegedly fractured on the right side with migration to the right heart border. Subsequently, on the same day, the port was removed. However, the current status of the patient remains unknown.

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

  MAUDE report 50249145 ↗
• InjuryMar 17, 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, SEPTIC EMBOLI AND RECURRENT PNEUMONIA. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Embolism/Embolus; Pneumonia; Unspecified Infection

  MAUDE report 24614958 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE ON (B)(6) 2010, VIA RIGHT INTERNAL JUGULAR VEIN FOR TREATMENT OF LYMPHOMA. APPROXIMATELY FOUR WEEKS LATER, ON (B)(6) 2010, THE PATIENT PRESENTED TO THE HOSPITAL WITH TACHYCARDIA, AND SUBSEQUENTLY WAS DIAGNOSED WITH AN INFECTION. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) BACTEREMIA. FURTHER, THE DEVICE WAS REMOVED ON (B)(6) 2010. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Bacteremia; Tachycardia; Unspecified Infection

  MAUDE report 24345552 ↗
• InjuryJul 28, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, CATHETER FRACTURE AND MIGRATION WERE OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22628676 ↗
• MalfunctionNov 1, 2024Fracture; Fracture; Device Appears to Trigger Rejection; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 20586978 ↗
• InjuryOct 17, 2024Fracture; Material Too Rigid or Stiff; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fracture; Material Too Rigid or Stiff; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration

  IT WAS REPORTED THAT FIFTEEN YEARS, ONE MONTH AND TWENTY DAYS POST A PORT PLACEMENT, THE PORT WAS PLANNED FOR REMOVAL DUE TO RECURRENT FEBRILE EPISODES AND NON-FUNCTIONAL IMPLANTABLE CHAMBER. IT WAS FURTHER REPORTED THAT THE CATHETER RUPTURED DURING REMOVAL AND ALLEGEDLY MIGRATED INTO THE RIGHT VENTRICLE. FURTHERMORE, THE PART OF THE CATHETER RECOVERED ALLEGEDLY APPEARED FRAGILE WITH A FRIABLE ASPECT OF THE SILICONE AND TWO SECTIONS OF SILICONE IN THE TWO CENTIMETERS UPSTREAM OF THE RUPTURED ZONE. REPORTEDLY, THE CATHETER PIECE WAS RETRIEVED VIA FEMORAL ROUTE AND THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Fever

  MAUDE report 20472583 ↗
• MalfunctionMay 3, 2024Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT TWO MONTHS AND THREE DAYS POST PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236553 ↗
• InjuryApr 16, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19113798 ↗
• MalfunctionJan 10, 2023Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE NEEDLE ALLEGEDLY HAD A CRACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128841 ↗
• InjuryDec 1, 2022Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT FIFTEEN YEARS EIGHT MONTHS AND TEN DAYS POST PORT PLACEMENT, THE PART OF THE CATHETER ALLEGEDLY FRACTURED AND SEPARATED. IT WAS FURTHER REPORTED THAT UPON X-RAY IMAGING, THE CATHETER ALLEGEDLY MIGRATED TO THE HEART. REPORTEDLY, THE REMNANT FRAGMENT WAS STILL INSIDE THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 15896491 ↗
• InjuryNov 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT PROCEDURE, A CHEST X-RAY EXAMINATION WAS PERFORMED AND DEMONSTRATED THAT STYLET WAS ALLEGEDLY LEFT IN THE CATHETER INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT ADDITIONAL INTERVENTIONAL WAS REQUIRED TO REMOVE THE STYLET. PATIENT CURRENT STATUS WAS UNKNOWN.

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

  MAUDE report 12802477 ↗
• InjurySep 9, 2021Fracture; Material Separation; Dent in Material; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fracture; Material Separation; Dent in Material; Deformation Due to Compressive Stress; Naturally Worn; Migration

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS 4 MONTHS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY RUPTURED AND MIGRATED INTO HART CHAMBERS. IT WAS FURTHER REPORTED THAT CATHETER SEGMENTS ARE REMOVED FROM THE PATIENT. PATIENT CURRENT STATUS IS UNKNOWN.

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

  MAUDE report 12444690 ↗
• InjuryMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD LEAKAGE AND THE PATIENT EXPERIENCED PAIN. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11587272 ↗
• InjuryMar 9, 2021Fracture; Difficult to Advance; Migration; Fracture; Difficult to Advance; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT AN IMPLANTABLE PORT WAS PLACED IN A PATIENT, THE REASON FOR PLACEMENT WAS NOT GIVEN. APPROXIMATELY THREE MONTHS AFTER PORT PLACEMENT, THE DEVICE ALLEGEDLY FRACTURED AND MIGRATED TO THE PATIENT'S RIGHT VENTRICLE. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT HEART SURGERY TO REMOVE THE FRACTURED CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11444198 ↗
• InjuryDec 28, 2020Fluid/Blood Leak; Fracture; Material Separation; Dent in Material; Migration; Fluid/Blood Leak; Fracture; Material Separation; Dent in Material; Migration

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, DURING FLUSHING, THE CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED AT THE LEVEL OF THE LEFT CLAVICLE AND THE PATIENT EXPERIENCED CHEST PAIN. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE CATHETER, THE CATHETER WAS COMPLETELY FRACTURED AND THROUGH IMAGING EXAMINATION, THE TIP OF THE CATHETER WAS LOCATED NEAR THE ENTRANCE TO THE RIGHT ATRIUM. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Chest Pain

  MAUDE report 11075352 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE CATHETER NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010063 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT, THE CATHETER NEEDLE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009815 ↗
• InjuryMar 25, 2020Disconnection; Fracture; Material Separation; Deformation Due to Compressive Stress; Disconnection; Fracture; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SEVEN YEARS SIX MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY DETACHED FROM THE HUB AND MIGRATED TO THE RIGHT HEART, WHICH WAS REVEALED THROUGH IMAGING, ECHOCARDIOGRAM, AND TRANS-ESOPHAGEAL DIAGNOSTIC TESTS. IT WAS FURTHER REPORTED THAT THE CATHETER WAS VISUALIZED IN THE RIGHT ATRIUM WITH AN ATTACHED DENSITY SUSPECTED TO A PORTION OF THE CATHETER OR THROMBUS. REPORTEDLY, THE PORT BODY AND CATHETER WERE REMOVED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED HOME AND REPORTED TO BE HEMODYNAMICALLY STABLE.

  Patient problems: Pericardial Effusion; Thrombus

  MAUDE report 9880959 ↗
• MalfunctionNov 6, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE CATH LOCK WAS MISSING WHEN THE KIT WAS OPENED IN THE OR (OPERATING ROOM) AND ANOTHER KIT WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT USE IN/ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8043816 ↗
• MalfunctionAug 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PORT CATHETER ALLEGEDLY HAD A PARTIAL RUPTURE, WHICH DISABLED THE CATHETER TO BE USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7807497 ↗