BardPort M.R.I., Groshong 0603870Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741025839), received between Jun 22, 2016 and Sep 18, 2025 — classified as 1 death, 10 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 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 23081584 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, DURING A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY HAD MALFUNCTION OF THE CENTRAL VENOUS ACCESS PORT NEEDLE OF THE PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640761 ↗
• InjuryApr 25, 2024Fluid/Blood Leak; Fracture; Difficult to Remove; Material Separation; Migration; Fluid/Blood Leak; Fracture; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THAT ONE MONTH AND ONE DAY POST A PORT PLACEMENT, THE PORT ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE IN THE HEART PLANE UPON X-RAY IMAGING. IT WAS ALSO REPORTED THAT THE CATHETER WAS ALLEGEDLY UNABLE TO BE REMOVED EITHER THROUGH JUGULAR OR FEMORAL VEINS AND UPON COMPUTED TOMOGRAPHIC EXAMINATION, THE CATHETER WAS ALLEGEDLY FOUND IN THE RIGHT AND THE LEFT PULMONARY ARTERY. REPORTEDLY, THE PORT WAS REMOVED AND ONLY THE MINOR PART OF THE CATHETER WAS FIXED BY THE SLEEVE AND THE REMAINING PART WAS ALLEGEDLY TORN AWAY AND MIGRATED. 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 19183698 ↗
• InjuryApr 25, 2024Disconnection; Entrapment of Device; Difficult to Remove; Material Separation; Migration; Disconnection; Entrapment of Device; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED SWELLING AROUND THE PORT AREA WHILE INFUSION. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE DISCONNECTED FROM THE PORT UPON X-RAY EXAMINATION AND THE CATHETER ALLEGEDLY MIGRATED TO THE RIGHT HEART. IT WAS ALSO REPORTED THAT THE CATHETER WAS STUCK IN THE HEART AND WAS UNABLE TO BE REMOVED. FURTHERMORE, SEPARATION OF THE CATHETER AND THE PORT AT THE PLACE OF FIXATION WAS ALLEGEDLY NOTICED. REPORTEDLY, THE CATHETER WAS REMOVED AT LATER STAGE IN THE OPERATING ROOM AND THE PORT WAS REMOVED AS WELL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19183408 ↗
• MalfunctionOct 5, 2023Disconnection; Fluid/Blood Leak; Material Protrusion/Extrusion; Disconnection; Fluid/Blood Leak; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY FIFTEEN DAYS POST PORT PLACEMENT, THE PORT DIAPHRAGM WAS ALLEGEDLY DISCONNECTED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878462 ↗
• InjuryJul 27, 2022Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE AND MIGRATED TO RIGHT ATRIUM. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

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

  MAUDE report 15110645 ↗
• InjuryJul 21, 2022Fracture; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER AND SHEATH ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT CATHETER ALLEGEDLY FAILED TO ADVANCE. THE TEAR WAS NOTED IN THE RIGHT SUBCLAVIAN VEIN AND EXPERIENCED BLEEDING. THE CURRENT STATUS OF THE PATIENT WAS REPORTED TO BE STABLE.

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

  MAUDE report 15071854 ↗
• MalfunctionApr 2, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PORT DEVICE IMPLANT PROCEDURE, THE TIP ALLEGEDLY DAMAGED AND GOT WRINKLED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13987417 ↗
• MalfunctionFeb 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT, THE TIP OF THE CATHETER ALLEGEDLY HAD BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13421585 ↗
• InjuryNov 22, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT AND UPON IMAGING, EXTRAVASATION WAS ALLEGEDLY NOTED AND A CRACK WAS NOTED ON THE DEVICE. THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 12850430 ↗
• MalfunctionJun 1, 2021Difficult to Flush; Difficult to Remove; Obstruction of Flow; Difficult to Flush; Difficult to Remove; Obstruction of Flow

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD AN OBSTRUCTION OF FLOW AND HAD DIFFICULTY IN FLUSHING IN THE TUBING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11911491 ↗
• InjuryMay 25, 2021Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE CATHETER OF THE DEVICE ALLEGEDLY FRACTURED AND MIGRATED. THE PATIENT ALLEGEDLY EXPERIENCED PARESTHESIA, PAIN AND HEART INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11874931 ↗
• MalfunctionOct 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0603880C IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738016 ↗
• MalfunctionApr 14, 2020Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0603870 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED DIFFICULT TO INSERT AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF THE 35 YEAR OLD FEMALE WAS 51 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959085 ↗
• MalfunctionJan 15, 2020Defective Component; Deformation Due to Compressive Stress; Defective Component; Deformation Due to Compressive Stress

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0603870 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED DEFECTIVE COMPONENTS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE (B)(6) YEAR OLD MALE PATIENT WEIGHED (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593807 ↗
• MalfunctionJul 23, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 603870 PORT & CATHETER ALLEGEDLY HAD AN IMPROPER OR INCORRECT PROCEDURE OR METHOD. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITHOUT CONSEQUENCE. THE PATIENT AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818064 ↗
• MalfunctionJul 18, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0603870 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED DEFECTIVE COMPONENTS. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8803508 ↗
• MalfunctionApr 29, 2019Component Incompatible; Defective Component; Component Incompatible; Defective Component

  IT WAS REPORTED THAT DURING ADVANCEMENT WITH FORCE, THE DILATOR ALLEGEDLY BECAME WRINKLED WHICH CAUSED THE GUIDE WIRE TO ALLEGEDLY FOLD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561167 ↗
• InjuryMar 29, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST PORT SYSTEM PLACEMENT IN THE RIGHT INTERNAL JUGULAR FOR CHEMOTHERAPY TREATMENT OF COLON CANCER, THE CATHETER ALLEGEDLY MIGRATED INTO THE LUNG IDENTIFIED VIA CT SCAN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THE PATIENT STATUS IS UNKNOWN POST REMOVAL PROCEDURAL.

  Patient problems: Injury

  MAUDE report 8464973 ↗
• InjuryFeb 21, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SECOND CHEMOTHERAPY TREATMENT, A LEAK WAS NOTICED AT THE PORT CHAMBER LEVEL. IT WAS FURTHER REPORTED THAT THE PORT CHAMBER WAS REMOVED APPROXIMATELY ONE MONTH POST PORT DEVICE IMPLANT. REPORTEDLY, DURING THE REMOVAL PROCEDURE, THE SURGEON NOTICED THAT THE DEVICE HAD ALLEGEDLY BROKE AND MIGRATED TO THE VENTRICLE. THE PATIENT STATUS IS UNKNOWN POST REMOVAL PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8359767 ↗
• InjuryFeb 14, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY HEARD THE DEVICE CRACK WHILE SLEEPING. REPORTEDLY, THE HEALTHCARE PROVIDER EXAMINED VIA X-RAY IMAGE AND APPROVED THE CATHETER FOR CHEMOTHERAPY USE, HOWEVER, DURING CHEMOTHERAPY THE PATIENT ALLEGED PAIN SO THE INFUSION WAS INTERRUPTED. FURTHERMORE, A CONTRAST IMAGE EXAMINATION DEMONSTRATED AN ALLEGED CATHETER BREAK. REPORTEDLY, THE CATHETER MIGRATED TO THE HEART, AND THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism

  MAUDE report 8339387 ↗
• MalfunctionJan 14, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE DILATOR BECAME BENT DURING PLACEMENT, WHICH MADE THE CATHETER PROGRESSION IMPOSSIBLE. IT WAS FURTHER REPORTED THAT A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246373 ↗
• MalfunctionNov 26, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE DILATOR OF THE PORT CATHETER BECAME BENT, MAKING THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8104356 ↗
• MalfunctionSep 4, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PORT CATHETER INSERTION, THERE WAS ALLEGED SWELLING AND FLEXING OF THE TUNNELING MANDREL. IT WAS FURTHER REPORTED THAT THE TUNNELER WAS UNABLE TO BE PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844436 ↗
• MalfunctionSep 4, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PORT CATHETER INSERTION, THERE WAS ALLEGED SWELLING AND FLEXING OF THE TUNNELING MANDREL. IT WAS FURTHER REPORTED THAT THE TUNNELER WAS UNABLE TO BE PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844397 ↗