BardPort M.R.I., Groshong 0602833Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00801741025723), received between May 9, 2018 and Aug 6, 2026 — classified as 23 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Fracture” (52 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 88 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Burst Container or Vessel; Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  A patient underwent a port placement procedure using an M.R.I. Implantable Port. Post procedure on (b)(6)2026, swelling was noted around the port during medication administration and was suspected to be due to subcutaneous leakage. Following X ray evaluation and other diagnostic testing, the port was removed, and a catheter fracture was identified. The current status of the patient was unknown.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 50152624 ↗
• MalfunctionMay 4, 2026Failure to Advance; Deformation Due to Compressive Stress

  THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. PORT. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER COULD NOT BE ADVANCED DUE TO THE INNER TUBE OF THE SHEATH BEING CRUSHED AT MULTIPLE LOCATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065028 ↗
• MalfunctionJan 30, 2026Fracture; Material Separation; Connection Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F. DURING THE PROCEDURE, WHEN ADVANCING THE CATHETER LOCK DURING CONNECTION OF THE PORT BODY AND CATHETER, THE CATHETER LOCK DID NOT ENGAGE PROPERLY, AND THE STEM BROKE WHEN IT WAS PULLED STRAIGHT OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219261 ↗
• InjuryNov 18, 2025Degraded; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration; Degraded; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Migration

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. IMPLANTABLE PORT. POST PROCEDURE, ON (B)(6) 2025, IT WAS REPORTED THAT DURING AN OUTPATIENT VISIT, A CT SCAN REVEALED THAT THE CATHETER HAD RUPTURED. 12 DAYS LATER, THE REMAINING PORTION OF THE CATHETER WAS SUCCESSFULLY REPOSITIONED AND RETRIEVED FROM THE RIGHT INTERNAL JUGULAR VEIN USING A SNARE IN THE CARDIOLOGY DEPARTMENT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 23581040 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. IMPLANTABLE PORT. POST PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY FOUND BROKEN AND LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437273 ↗
• MalfunctionJul 28, 2025Fluid/Blood Leak; Fracture; Material Puncture/Hole; Reflux within Device; Material Separation; Fluid/Blood Leak; Fracture; Material Puncture/Hole; Reflux within Device; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FOUND SALINE CAME OUT FROM TWO PLACES AFTER APPLIED A LOT OF PRESSURE TO THE CATHETER BY HAND. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY FOUND BREAKAGE. REPORTEDLY, CATHETER ALLEGEDLY FOUND HOLE AND BLOOD FOUND TO BE BLEED BACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628603 ↗
• MalfunctionJul 2, 2025Fracture; Material Separation; Fracture; Material Separation

  A FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE MRI POWERPORT ISP. ON (B)(6) 2025 POST PROCEDURE, IT WAS FOUND THAT THE CATHETER ALLEGEDLY BROKEN AND GOT SEPARATED. THE PORT BODY AND CATHETER ARE STILL IN THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380489 ↗
• InjuryJan 1, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT FIVE YEARS POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD A LEAK. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN WHEN INJECTING THE DRUG SOLUTION. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED EXTRAVASATION. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; Pain

  MAUDE report 21051397 ↗
• MalfunctionDec 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A PREPARATION OF PORT PLACEMENT PROCEDURE, WHEN CHECKING THE PORT BODY BEFORE USE BLACK FOREIGN MATTER WAS ALLEGEDLY FOUND ON THE SIDE OF THE PORT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905834 ↗
• MalfunctionSep 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT TWO YEARS AND EIGHT MONTHS POST A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD A PARTIAL CRACK IN THE CATHETER SITE AT A LOCATION CONSISTENT WITH THE SITE OF CERVICAL REDNESS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308633 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO YEARS AND EIGHT MONTHS POST A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD RIGHT CERVICAL REDNESS DUE TO DRUG LEAKAGE DURING CHEMOTHERAPY. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT UNDERWENT ANY MEDICAL INTERVENTION NOR MEDICATIONS PRESCRIBED FOR CERVICAL REDNESS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302048 ↗
• InjurySep 4, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE A LONG TIME AGO BECAUSE REGULAR MAINTENANCE WAS NEGLECTED AFTER THE PORT WAS NO LONGER IN USE. IT WAS FURTHER REPORTED THAT THE CATHETER FRAGMENTS MOVED TO INTRACARDIAC HAVE BEEN REMOVED PERCUTANEOUSLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20133074 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN WHILE INFUSING SALINE. IT WAS FURTHER REPORTED THAT THE PORT WAS ALLEGEDLY FOUND TO HAVE A LEAK. FURTHERMORE, THERE IS NO INFORMATION REGARDING ADDITIONAL INTERVENTION NOR MEDICATIONS PRESCRIBED TO TREAT PAIN. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 20126592 ↗
• MalfunctionAug 5, 2024Fracture; Material Separation; Stretched; Failure to Advance; Material Integrity Problem; Fracture; Material Separation; Stretched; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDE WIRE WAS ALLEGEDLY DID NOT GO TO THE DESIRED LOCATION. IT WAS FURTHER REPORTED THAT THE WIRE WAS DAMAGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905065 ↗
• InjuryJun 19, 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 SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY COMPLAINED OF PAIN WHEN ADMINISTERING THE DRUG AND THE CATHETER WAS ALLEGEDLY FOUND TO BE TORN AND FLOATED ON CENTRAL VEIN UNDER FLUOROSCOPY EXAMINATION. IT WAS FURTHER REPORTED THAT DURING INFUSION, THE SALINE ALLEGEDLY LEAKED. FURTHERMORE, THE PATIENT DID NOT UNDERWENT ANY MEDICAL INTERVENTION NOR MEDICATIONS PRESCRIBED TO TREAT PAIN. REPORTEDLY, THE FLOATED PART OF THE CATHETER HAS BEEN RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19564806 ↗
• MalfunctionMar 23, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE STEM PART WAS ALLEGEDLY BROKEN WHEN CONNECTING THE CATHETER. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DID NOT FORCEFULLY MANIPULATE IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966167 ↗
• MalfunctionDec 28, 2023Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, WHILE OPENING THE PACKAGE IT WAS NOTICED THAT THE PLASTIC PART AND THE RUBBER PART OF THE SYRINGE BODY WERE ALLEGEDLY NOT CONNECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407885 ↗
• MalfunctionNov 29, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD A SUBCUTANEOUS LEAKAGE DURING DRUG ADMINISTRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226059 ↗
• MalfunctionJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE YEAR TWO MONTHS AND SEVENTEEN DAYS POST PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY EXPERIENCED REDNESS OF THE NECK DURING CHEMOTHERAPY AND FEVER WAS NOTED. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077370 ↗
• MalfunctionJun 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT ONE YEAR THREE MONTHS AND TWENTY-EIGHT DAYS DAYS POST PORT PLACEMENT, UPON REMOVAL A CRACK WAS ALLEGEDLY OBSERVED AT A SITE COINCIDING WITH THE REDDENED NECK PORTION OF THE REMOVED CATHETER. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077311 ↗
• MalfunctionApr 10, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT ONE YEAR THREE MONTHS AND TWENTY THREE DAYS POST PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN FOR CHEMOTHERAPY, THE CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE DISTAL CATHETER SEGMENT WAS REMOVED. REPORTEDLY, THE PORT BODY WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705617 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT THREE MONTHS AND TWENTY-THREE DAYS POST PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND TO BE CRACKED NEAR THE PORT STEM. IT WAS FURTHER REPORTED THAT THE SUBCUTANEOUS LEAKAGE HAD ALLEGEDLY OCCURRED FROM THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED REPLACING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619093 ↗
• MalfunctionMar 17, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SOME TIME POST A PORT PLACEMENT, A HOLE WAS FORMED ON THE CATHETER IN THE CATHETER LOCK. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED SYMPTOMS OF PAIN. REPORTEDLY, THE PORT SYSTEM WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567195 ↗
• MalfunctionFeb 16, 2023Fracture; Air/Gas in Device; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, AIR WAS ALLEGEDLY ASPIRATED IN DEVICE DURING ASPIRATION BETWEEN THE SYRINGE AND THE INTRODUCER NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384237 ↗
• MalfunctionDec 29, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, FOREIGN MATERIAL LIKE HAIR WAS ALLEGEDLY FOUND IN THE KIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16066128 ↗