BardPort, Groshong 0602810Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741025693), received between Aug 9, 2018 and Jan 12, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Fracture; Material Separation; Migration

  ON (B)(6) 2021, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F. POST THE PROCEDURE ON (B)(6) 2025, DURING REMOVAL OF THE CIP, IT WAS NOTED THAT THE CATHETER WAS RUPTURED AND SEPARATED. THE CATHETER WAS REMOVED. REPORTEDLY, IN A POST-REMOVAL CHEST X-RAY, IT WAS FURTHER REPORTED THAT A PIECE OF CATHETER HAD MOVED INTO THE RIGHT HEART CHAMBER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 24033327 ↗
• InjuryJan 12, 2026Fracture; Material Separation; Migration

  ON (B)(6) 2021, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F. POST THE PROCEDURE ON (B)(6) 2025, DURING REMOVAL OF THE CIP, IT WAS NOTED THAT THE CATHETER WAS RUPTURED AND SEPARATED. THE CATHETER WAS REMOVED. REPORTEDLY, IN A POST-REMOVAL CHEST X-RAY, IT WAS FURTHER REPORTED THAT A PIECE OF CATHETER HAD MOVED INTO THE RIGHT HEART CHAMBER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 24033281 ↗
• 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 PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23825592 ↗
• MalfunctionApr 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE DAY POST PORT PLACEMENT PROCEDURE, MICRODROPLETS FORMATION WAS IDENTIFIED IN THE CATHETER WALL, AND CAUSED THE LEAKAGE. PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21812894 ↗
• InjuryJan 30, 2025Fracture; Difficult to Remove; Material Separation; Fracture; Difficult to Remove; Material Separation

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

  Patient problems: Extravasation; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270789 ↗
• InjuryNov 27, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT A PART OF THE CATHETER HAD MIGRATED TO THE RIGHT PULMONARY ARTERY. REPORTEDLY, PROGRAMMING OF SURGICAL PROCEDURES WAS DONE TO REMOVE THE CATHETER AND THE IMPLANTABLE CHAMBER. THE PATIENT IS REPORTED TO BE STABLE NOW.

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

  MAUDE report 18208113 ↗
• InjuryNov 27, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT A PART OF THE CATHETER HAD MIGRATED TO THE RIGHT PULMONARY ARTERY. REPORTEDLY, PROGRAMMING OF SURGICAL PROCEDURES WAS DONE TO REMOVE THE CATHETER AND THE IMPLANTABLE CHAMBER. THE PATIENT IS REPORTED TO BE STABLE NOW.

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

  MAUDE report 18208112 ↗
• InjuryNov 24, 2023Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT A PART OF THE CATHETER HAD MIGRATED TO THE RIGHT PULMONARY ARTERY. REPORTEDLY, PROGRAMMING OF SURGICAL PROCEDURES WAS DONE TO REMOVE THE CATHETER AND THE IMPLANTABLE CHAMBER. THE PATIENT IS REPORTED TO BE STABLE NOW.

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

  MAUDE report 18203911 ↗
• InjuryMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY THIRTY ONE DAYS POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER ALLEGEDLY LEAKED AT THE SUTURE LINE. IT WAS FURTHER REPORTED THAT THE SUTURE SITE SHOWED SIGNS OF INFECTION AND THE INFECTION WAS TREATED. REPORTEDLY THE PORT CATHETER WAS REMOVED. THE PATIENT REPORTED TO BE STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema; Unspecified Infection

  MAUDE report 14394990 ↗
• InjuryMar 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS SEVEN MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY BROKE AT THE CONNECTION POINT AND MIGRATED TO THE HEART, WHICH WAS CONFIRMED BY X-RAY IMAGING. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY INTERVENTIONAL RADIOLOGY. THE PATIENT IS REPORTED AS STABLE.

  Patient problems: Injury

  MAUDE report 9878121 ↗
• MalfunctionJul 22, 2019Failure to Infuse; Failure to Infuse

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0602810 IMPLANTED PORT ALLEGEDLY WAS UNABLE TO BE INFUSED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814186 ↗
• InjuryJan 24, 2019Break; Break

  IT WAS REPORTED THAT TWO YEARS AND TWO MONTHS POST PORT PLACEMENT, A SCAN ALLEGEDLY DEMONSTRATED THE PORT CATHETER RUPTURED AND MIGRATED TO THE ARTERY LEVEL OF THE LEFT LUNG. IT WAS FURTHER REPORTED THAT THE ADDITIONAL INTERVENTION WAS USED TO COMPLETE REMOVAL OF THE MIGRATED SEGMENT. REPORTEDLY, THE DEVICE WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8276398 ↗
• MalfunctionAug 9, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THE PORT WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN. PATIENT COMPLAINED OF PAIN AND SWELLING DURING INFUSION. ULTRASOUND REVEALED A CRACK IN THE CATHETER WITH A CONTRAST LEAK NEAR THE LIMB AND INSERTION SITE. DEVICE WAS REMOVED IN INTERVENTIONAL RADIOLOGY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 7770364 ↗