BardPort M.R.I. 0603880Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00801741025846), received between May 17, 2018 and Jan 29, 2026 — classified as 36 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Fracture” (23 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 78 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Difficult to Flush; Fracture; Material Separation; Suction Problem; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, ON (B)(6) 2011, A PATIENT WAS IMPLANTED WITH A PORT VIA THE LEFT SUBCLAVIAN VEIN FOR AS THE PATIENT WAS IN NEED FOR CENTRAL VENOUS ACCESS TO TREAT IRON DEFICIENCY. APPROXIMATELY ELEVEN MONTHS AND EIGHT DAYS LATER ON (B)(6) 2022, THAT CATHETER WAS ALLEGEDLY FRACTURED AND THE FRAGMENT MIGRATED TO RIGHT ATRIUM. IT WAS FURTHER REPORTED THAT THE PORT STOPPED FUNCTIONING AS BLOOD COULD NOT BE ASPIRATED AND FLUSHING WAS UNSUCCESSFUL. IMAGING, INCLUDING CT OF THE NECK WITH CONTRAST, SHOWED SEVERE NARROWING OF THE LEFT BRACHIOCEPHALIC AND SUBCLAVIAN VEINS AROUND THE PORT CATHETER WITH COLLATERAL FORMATION THROUGHOUT THE NECK, CHEST WALL, AND MEDIASTINUM THIS MAY BE RESPONSIBLE FOR THE PATIENT'S LEFT UPPER EXTREMITY SWELLING. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Stenosis; Swelling/ Edema

  MAUDE report 24208707 ↗
• MalfunctionDec 8, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23736117 ↗
• MalfunctionMar 26, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE INTRODUCER SHEATH WAS ALLEGEDLY BROKEN WHEN TRIED TO PASS 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 21695177 ↗
• InjuryMar 19, 2025Difficult to Insert; Dull, Blunt; Difficult to Insert; Dull, Blunt

  IT WAS REPORTED THAT SOMETIMES DURING PORT PLACEMENT PROCEDURE THE PORT SHEATH ALLEGEDLY GOT BLUNT DURING THE CHEMO PORT IMPLANTATION. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED HEMATOMA IN THE NECK AND THE VEIN WAS THROMBOSED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hematoma; Thrombosis/Thrombus

  MAUDE report 21644427 ↗
• MalfunctionMar 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SOMETIMES A POST PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY PERFORATED AFTER THE SET WAS FIXED. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628848 ↗
• MalfunctionDec 12, 2024Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY MIGRATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915006 ↗
• MalfunctionSep 12, 2024Failure to Advance; Deformation Due to Compressive Stress; Material Integrity Problem; Failure to Advance; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DILATOR AND TROCAR WAS ALLEGEDLY BENT AND DID NOT PROGRESS. IT WAS FURTHER REPORTED THAT TIP WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205430 ↗
• MalfunctionAug 12, 2024Fracture; Difficult to Insert; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Fracture; Difficult to Insert; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY FOUND TO BE FOLDED UPON OPENING THE PACKAGE AND WAS ALLEGEDLY GETTING STUCK WHILE INSERTING INTO THE DILATOR. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY HAD BENDS AND FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958695 ↗
• MalfunctionAug 9, 2024Fracture; Difficult to Insert; Material Separation; Stretched; Unraveled Material; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Fracture; Difficult to Insert; Material Separation; Stretched; Unraveled Material; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE WIRES ALLEGEDLY CAME WITH FOLDS IN THE PACKAGING, GETTING STUCK IN THE DILATOR. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS FRACTURED WHILE OPENING OF PACKAGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947239 ↗
• InjuryJul 5, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO YEARS, TWO MONTHS, AND TWENTY-SEVEN DAYS POST A PORT PLACEMENT IN THE RIGHT SUBCLAVIAN VEIN, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE FRACTURED CATHETER HAD ALLEGEDLY EMBOLIZED TO THE PATIENT'S RIGHT ATRIUM AND RIGHT VENTRICLE. FURTHERMORE, THE CATHETER ALLEGEDLY TRAVERSED THE TRICUSPID VALVE INTO THE PATIENT'S RIGHT VENTRICLE CAUSING TRICUSPID VALVE REGURGITATION. REPORTEDLY, THE PATIENT UNDERWENT SURGERY FOR RETRIEVING THE FRACTURED AND EMBOLIZED CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19678021 ↗
• MalfunctionApr 11, 2024Fracture; Difficult to Insert; Dull, Blunt; Fracture; Difficult to Insert; Dull, Blunt

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN TRIED TO DILATE THE VEIN, THE INTERNAL DILATOR WAS ALLEGEDLY NOTED WITH A BLUNT TIP. IT WAS FURTHER REPORTED THAT WHEN TRIED TO DILATE, THE TIP OF THE INTERNAL DILATOR ALLEGEDLY BROKE. FURTHERMORE IT WAS NOT POSSIBLE TO INSERT THE DEVICE AND THERE WAS BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086356 ↗
• MalfunctionApr 11, 2024Fracture; Difficult to Insert; Dull, Blunt; Fracture; Difficult to Insert; Dull, Blunt

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN TRIED TO DILATE THE VEIN, THE INTERNAL DILATOR WAS ALLEGEDLY NOTED WITH A BLUNT TIP. IT WAS FURTHER REPORTED THAT WHEN TRIED TO DILATE, THE TIP OF THE INTERNAL DILATOR ALLEGEDLY BROKE. FURTHERMORE IT WAS NOT POSSIBLE TO INSERT THE DEVICE AND THERE WAS BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086307 ↗
• MalfunctionApr 11, 2024Fracture; Difficult to Insert; Dull, Blunt; Fracture; Difficult to Insert; Dull, Blunt

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN TRIED TO DILATE THE VEIN, THE INTERNAL DILATOR WAS ALLEGEDLY NOTED WITH A BLUNT TIP. IT WAS FURTHER REPORTED THAT WHEN TRIED TO DILATE, THE TIP OF THE INTERNAL DILATOR ALLEGEDLY BROKE. FURTHERMORE IT WAS NOT POSSIBLE TO INSERT THE DEVICE AND THERE WAS BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086299 ↗
• MalfunctionMar 23, 2024Fracture; Difficult to Insert; Dull, Blunt; Deformation Due to Compressive Stress; Fracture; Difficult to Insert; Dull, Blunt; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN TRIED TO DILATE THE VEIN, THE INTERNAL DILATOR WAS ALLEGEDLY NOTED WITH BLUNT TIP. IT WAS FURTHER REPORTED THAT WHEN TRIED TO DILATE, THE INTERNAL DILATOR ALLEGEDLY BROKE ITS TIP. FURTHERMORE, THE PASSAGE WAS NOT POSSIBLE AND THE ATTEMPT TO PASS THE CATHETER CAUSED MORE BLEEDING THAN EXPECTED. REPORTEDLY, THE PROCEDURE WAS SUSPENDED AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966214 ↗
• InjuryFeb 5, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY SLIPPED INTO HEART. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN WHILE REMOVAL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 18638956 ↗
• InjuryJun 30, 2023Disconnection; Difficult to Flush; Blocked Connection; Migration; Disconnection; Difficult to Flush; Blocked Connection; Migration

  IT WAS REPORTED THAT FOUR MONTHS AND NINETEEN DAYS POST PORT PLACEMENT, THE DOCTOR ALLEGEDLY FELT A DIFFICULTY IN INJECTING THE PRODUCT WHILE INSERTING THE NEEDLE FOR THE INJECTION OF AN IMMUNOTHERAPY TREATMENT. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CHAMBER CATHETER ALLEGEDLY DISCONNECTED FROM THE CHAMBER BOX. REPORTEDLY, THE CATHETER WAS FOUND TO BE MIGRATED BETWEEN THE SUPERIOR VENA CAVA AND THE RIGHT VENTRICLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 17236506 ↗
• MalfunctionMay 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE YEAR EIGHT MONTHS AND TWENTY SEVEN DAYS POST PORT PLACEMENT, A LEAK WAS OBSERVED AT THE LEVEL OF THE PROXIMAL THIRD OF THE CATHETER. REPORTEDLY THE PORT SYSTEM WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16909149 ↗
• MalfunctionJan 28, 2023Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE INTRODUCER WAS ALLEGEDLY PRESENTED TORSION DURING PASSAGE THROUGH THE RIGHT INTERNAL JUGULAR VEIN, WITH SUBSEQUENT DEFORMITY OF THE SAME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261478 ↗
• MalfunctionJul 23, 2022Fracture; Defective Component; Deformation Due to Compressive Stress; Fracture; Defective Component; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DILATOR ALLEGEDLY DID NOT DILATED PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090229 ↗
• MalfunctionMay 9, 2022Unsealed Device Packaging; Difficult to Open or Remove Packaging Material; Packaging Problem; Unsealed Device Packaging; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT, THE STERILE INTERNAL PART WAS STUCK TO THE NON-STERILE EXTERNAL PART. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14334431 ↗
• MalfunctionMar 31, 2022Disconnection; Fluid/Blood Leak; Fracture; Disconnection; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT TWENTY-SEVEN DAYS POST PORT IMPLANTATION, THE DEVICE WAS ALLEGEDLY DISCONNECT BETWEEN THE IMPLANTABLE PORT HOUSING AND THE CATHETER. IT WAS FURTHER REPORTED THAT DURING THE INJECTION OF THE CONTRAST MEDIUM, LEAKAGE OF THE LATTER TO THE HOUSING-CATHETER INTERFACE AND ALONG THE PROXIMAL THIRD OF THE CATHETER WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13962715 ↗
• MalfunctionFeb 11, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST PORT PLACEMENT, THE DEVICE SEPTUM ALLEGEDLY DISLODGED FROM PORT BODY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT HOWEVER, THERE WAS NO MEDICAL INTERVENTION REQUIRED. REPORTEDLY, THE DEVICE WAS REMOVED. THE CURRENT PATIENT STATUS IS STABLE.

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

  MAUDE report 13511914 ↗
• InjuryJan 9, 2022Fracture; Material Separation; Dent in Material; Migration; Fracture; Material Separation; Dent in Material; Migration

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN INTO TWO PIECES. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE CATHETER HAD MIGRATED INTO THE RIGHT HEART CHAMBERS. REPORTEDLY, ADDITIONAL INTERVENTION REQUIRED TO RECOVER THE MIGRATED PART. THE STATUS OF THE PATIENT WAS REPORTED AS STABLE.

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

  MAUDE report 13201027 ↗
• MalfunctionDec 10, 2021Difficult to Insert; Deformation Due to Compressive Stress; Difficult to Insert; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE TIP ALLEGEDLY BENT AND IT CAUSED THE PROBLEM DURING INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12973937 ↗
• InjuryDec 1, 2021Material Puncture/Hole; Stretched; Material Puncture/Hole; Stretched

  IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST PORT PLACEMENT PROCEDURE, THE CATHETER RESERVOIR ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT PERI-CATHETER REGION ALLEGEDLY HAD BULGE. REPORTEDLY EXTRAVASATION WAS OBSERVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 12906391 ↗