BardPort, Groshong 0606150Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00801741026058), received between May 4, 2018 and Jun 4, 2026 — classified as 29 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fracture” (37 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Fracture; Device Tipped Over

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING A TITANIUM LOW-PROFILE PORT. DURING THE PROCEDURE, THE CATHETER WAS PLACED; HOWEVER, AT THE TIME OF SUTURING, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE CATHETER WAS SUBSEQUENTLY REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387304 ↗
• MalfunctionMay 22, 2026Entrapment of Device; Difficult to Remove

  EIGHT YEARS AGO, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE TITANIUM LOW PROFILE PORT. ON (B)(6) 2026, POST PROCEDURE, IT WAS REPORTED THAT DURING AN ATTEMPT TO REMOVE THE PORT, THE CATHETER HAD ADHERED TO THE BLOOD VESSEL AND COULD NOT BE REMOVED. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252083 ↗
• MalfunctionMar 30, 2026Fracture

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE TITANIUM LOW PROFILE PORT. ON (B)(6) 2026, POST THE IMPLANTATION, THE PORT WAS FOUND ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711203 ↗
• MalfunctionFeb 19, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386019 ↗
• InjuryJan 9, 2026Fracture; Material Separation; Migration

  ON (B)(6) 2021, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE TITANIUM LOW-PROFILE PORT. POST THE PROCEDURE ON (B)(6) 2025, DURING REMOVAL OF THE CIP, IT WAS NOTED THAT THE CATHETER WAS RUPTURED AND SEPARATED. REPORTEDLY, THE CATHETER WAS REMOVED. IN THE POST-REMOVAL CHEST X-RAY, IT WAS FOUND 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 24018529 ↗
• InjuryDec 18, 2025Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration

  ON (B)(6) , 2022, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN WITH THE PORT BODY POSITIONED ON THE RIGHT ANTERIOR CHEST FOR CHEMOTHERAPY ADMINISTRATION USING TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F. CHEMOTHERAPY WAS COMPLETED, AND MONTHLY FLUSHING CONTINUED FOR MAINTENANCE. POST THE PROCEDURE ON (B)(6) , 2025, THE PATIENT REPORTED NECK PAIN DURING FLUSHING, LEADING TO A SCHEDULED CV PORT REMOVAL ON (B)(6) , 2025. REPORTEDLY, ON (B)(6) , 2025, AN X-RAY REVEALED A FRACTURED CATHETER, WITH THE CATHETER TIP CONFIRMED TO HAVE MIGRATED INTO THE HEART. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 23836354 ↗
• InjuryDec 1, 2025Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F. AFTER THE PROCEDURE, THE DEVICE ALLEGEDLY SLIGHT INFILTRATION INTO THE PATIENT TISSUE AND THE CATHETER WAS ALLEGEDLY FOUND DAMAGED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Burning Sensation; Infiltration into Tissue; Inflammation; Pain; Swelling/ Edema

  MAUDE report 23678837 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F. DURING THE ADMINISTRATION OF THE CHEMICAL OXALIPLATINUM 170 MG IV, PATIENT EXPERIENCED PAIN IN THE RIGHT PECTORAL MUSCLE, WHERE THE PORT CATHETER WAS PLACED, AND NOTICED THAT IT APPEARED LARGER AND SWOLLEN COMPARED TO THE LEFT PECTORAL MUSCLE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23678675 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING TITANIUM LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED THE INFECTIOUS CELLULITIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 23678672 ↗
• InjuryJul 28, 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 22628559 ↗
• MalfunctionMay 8, 2025Fluid/Blood Leak; Fracture; Reflux within Device; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Reflux within Device; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT 6 YEARS, 2 MONTHS, 24 DAYS POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND SUBCUTANEOUS LEAKAGE OCCURRED. IT WAS REPORTED THAT THE CATHETER ALLEGEDLY OBSERVES A FISH MOUTH-LIKE CRACK, AND THE BLOOD WAS ALLEGEDLY FOUND TO BE BLEED BACK. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983387 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fracture; Reflux within Device; Material Integrity Problem; Fluid/Blood Leak; Fracture; Reflux within Device; Material Integrity Problem

  ON (B)(6) 2024 A PATIENT WAS IMPLANTED WITH GROSHONG TITANIUM PORT S/L. ON (B)(6) 2024, FIVE MONTHS AND THREE DAYS POST PORT PLACEMENT, SUBCUTANEOUS LEAKAGE OCCURRED, AND CATHETER DAMAGE WAS DISCOVERED. THE DEVICE WAS REMOVED ON (B)(6) 2024. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977492 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT REMOVAL PROCEDURE AFTER THAT 2 YEARS, 3 MONTHS, 30 DAYS OF USING GROSHONG TITANIUM PORT S/L. THE CATHETER WAS REMOVED DUE TO LEAKAGE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE CRACKED OVER 2/3 OF ITS CIRCUMFERENCE AT A DISTANCE OF 5 CM FROM THE IMPLANTABLE CHAMBER. A NEW IMPLANTABLE CHAMBER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977194 ↗
• MalfunctionApr 24, 2025Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2016, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE GROSHONG TITANIUM PORT. ON (B)(6), 2025, DURING THE REMOVAL OF PORT, IT WAS NOTED THE CATHETER WAS PARTIALLY FRACTURED. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898732 ↗
• InjuryApr 21, 2025Collapse; Difficult to Flush; Device Appears to Trigger Rejection; Material Too Soft/Flexible; Collapse; Difficult to Flush; Device Appears to Trigger Rejection; Material Too Soft/Flexible

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER MATERIAL ALLEGEDLY BEING EXTREMELY FLEXIBLE, WHICH CAUSES STAINING. IT WAS FURTHER REPORTED THAT THE FLUID INFUSION DID NOT FLOW BACK, COLLAPSED AND DEFECTED. IN ADDITION, THE PATIENT HAD EVIDENCE OF A THROMBUS AND/OR FIBRIN SHEATH IN HAND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 21871865 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT IN THE INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY HAD REDNESS APPEARED AROUND THE CATHETER SUBCUTANEOUS TUNNEL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN PAIN, AND WHEN THE PORT WAS REMOVED, A CRACK WAS DISCOVERED IN THE CATHETER. REPORTEDLY, LEAKAGE WAS ALLEGEDLY OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 21319121 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX YEARS POST A PORT PLACEMENT, THE PATIENT EXPERIENCED BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT ANTIBIOTICS WERE GIVEN FOR INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 21052271 ↗
• InjuryJan 1, 2025Fracture; 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 FIVE YEARS, ELEVEN MONTHS, AND TWENTY-TWO DAYS POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED AND MIGRATED INTO THE PATIENT'S RIGHT VENTRICLE. REPORTEDLY, THE PIECE OF CATHETER LODGED IN THE HEART WAS REMOVED ENDOVASCULARLY. EVIDENTLY, THE PATIENT ALLEGEDLY EXPERIENCED BACTERIAL INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21051371 ↗
• InjuryNov 15, 2024Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST A PORT PLACEMENT, THE CATHETER WAS REMOVED AFTER IT WAS ALLEGEDLY FOUND TO BE FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED SWELLING AND SALINE ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER ALLEGEDLY MIGRATED AND WAS REMOVED USING A SNARE FROM THE FEMORAL VEIN. THE PORT AND CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 20693055 ↗
• MalfunctionSep 7, 2024Fracture; Difficult to Remove; Material Separation; Stretched; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Fracture; Difficult to Remove; Material Separation; Stretched; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PREPARATION OF A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY BLOCKED DURING MOBILITY TEST IN THE CANULA. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN REMOVAL. FURTHERMORE, THE GUIDEWIRE WAS ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164771 ↗
• MalfunctionJun 17, 2024Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Material Integrity Problem; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Material Integrity Problem; Naturally Worn

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, SUBCUTANEOUS LEAKAGE HAD ALLEGEDLY OCCURRED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY CONFIRMED TO BE DAMAGED UPON REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545230 ↗
• MalfunctionJun 12, 2024Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY FOUND TO BE RUPTURED UPON REMOVAL UNDER X-RAY EXAMINATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519378 ↗
• MalfunctionApr 15, 2024Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Deformation Due to Compressive Stress; Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE FLEXIBLE GUIDE INSERTED INTO THE PUNCTURE NEEDLE ALLEGEDLY BENT DOWNSTREAM OF THE NEEDLE. IT WAS FURTHER REPORTED THAT THE GUIDE WAS ALLEGEDLY IMPOSSIBLE TO BE REMOVED AND WAS ALLEGEDLY STRETCHED LIKE A SPRING. REPORTEDLY, THE WHOLE UNIT HAD TO BE REMOVED FROM THE VEIN TO REPEAT THE PROCEDURE WITH A NEW DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103324 ↗
• MalfunctionFeb 1, 2024Fracture; Difficult to Remove; Material Separation; Stretched; Failure to Advance; Fracture; Difficult to Remove; Material Separation; Stretched; Failure to Advance

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO REMOVE THUS REMOVED ALONG WITH THE NEEDLE DUE TO THE STRETCHING OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620880 ↗
• MalfunctionJan 6, 2024Degraded; Material Discolored; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Degraded; Material Discolored; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST A PORT PLACEMENT IN THE ANTERIOR THORACIC REGION AT THE RIGHT RADIAL SKIN CUT-DOWN, THE CATHETER WAS ALLEGEDLY FOUND TO BE TORN UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE DISCOLORED NEAR THE PORT BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461111 ↗