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BardPort M.R.I., Groshong 0604520Recalls & reported problems

Bard Access Systems, Inc. · BardPort M.R.I. Hard Base Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter Intermediate Kit · Class 2 · Implant

All models of BardPort M.R.I., Groshong (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
18
Deaths reported
0
Injuries reported
15
Recalls naming it
0

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741025853), received between Aug 10, 2018 and Mar 19, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture12
  • Migration9
  • Material Separation5
  • Adverse Event Without Identified Device or Use Problem3
  • Deformation Due to Compressive Stress3
  • Naturally Worn3
  • Appropriate Device Problem Term/Code Not Available1
  • Break1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
  • No Clinical Signs, Symptoms or Conditions4
  • Foreign Body In Patient3
  • Unspecified Infection3
  • Pain2
  • Thrombosis/Thrombus2
  • Discomfort1
  • Embolism/Embolus1

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 24637491 ↗
  • InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 24143228 ↗
  • InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME LATER, POST A PORT PLACEMENT, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 23971441 ↗
  • MalfunctionNov 4, 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 23464351 ↗
  • MalfunctionNov 4, 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 23464083 ↗
  • InjuryOct 15, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

    IT WAS REPORTED THAT TWENTY-SIX DAYS POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY SEPARATED. IT WAS FURTHER REPORTED THAT THE DISTAL SEGMENT OF THE CATHETER WAS ALLEGEDLY FOUND TO BE LODGED INSIDE THE PATIENT'S LEFT PULMONARY ARTERY. REPORTEDLY, THE CATHETER WAS REMOVED, BUT THE DISTAL SEGMENT OF THE CATHETER ALLEGEDLY REMAINED INSIDE THE PATIENT'S BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Foreign Body In Patient

    MAUDE report 20457144 ↗
  • InjuryApr 12, 2024Fracture; Material Separation; Material Twisted/Bent; Migration; Fracture; Material Separation; Material Twisted/Bent; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT ONE YEAR, SEVEN MONTHS, AND TWENTY-FIVE DAYS POST A PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN, THE DEVICE HAD ALLEGEDLY MALPOSITIONED WITH THE CATHETER ALLEGEDLY GOT COILED IN THE SUBCLAVIAN REGION. IT WAS FURTHER REPORTED THAT A RETAINED PIECE OF CATHETER MEASURING APPROXIMATELY NINE CENTIMETERS WAS FOUND TO BE EXTENDED ALONG THE LINGULAR PULMONARY ARTERIAL BRANCH WITH THE CATHETER TIP GOT TERMINATED IN THE DISTAL SUPERIOR VENA CAVA. REPORTEDLY, THE RETAINED PORTION OF THE FRACTURED CATHETER FRAGMENT WAS SUCCESSFULLY GRASPED AND REMOVED WITH A SNARE DEVICE AND THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19095292 ↗
  • MalfunctionApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHILE FLUSHING THE CATHETER, THE CATHETER ALLEGEDLY LEAKED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19017106 ↗
  • InjuryFeb 28, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

    IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE DISTAL END OF THE CHEMO PORT CATHETER ALLEGEDLY FOUND TO BE FRACTURED IN THE THIRD CYCLE OF CHEMOTHERAPY. IT WAS FURTHER REPORTED THAT THE FRACTURED CATHETER MIGRATED TO THE HEART REGION. REPORTEDLY THE MIGRATED SEGMENT WAS REMOVED THROUGH ANGIOGRAM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 16452076 ↗
  • InjuryJul 30, 2021Fracture; Migration; Fracture; Migration

    IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE AND MIGRATED INTO INFERIOR VENA CAVA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

    MAUDE report 12250926 ↗
  • InjuryJul 13, 2021Fracture; 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 SOME TIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE NEAR CONNECTION TO THE PORT STEM AND MIGRATED INTO HEART. IT WAS FURTHER REPORTED THAT CATHETER NEED TO REMOVED FORM THE BODY. PATIENT REPORTED TO BE STABLE.

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

    MAUDE report 12157472 ↗
  • InjuryJul 13, 2021Fracture; Deformation Due to Compressive Stress; Naturally Worn; Migration; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Migration

    IT WAS REPORTED APPROXIMATELY FOUR MONTHS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE NEAR CONNECTION TO THE PORT STEM AND MIGRATED INTO HEART. IT WAS FURTHER REPORTED THAT CATHETER NEED TO REMOVED FORM THE BODY. PATIENT REPORTED STABLE.

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

    MAUDE report 12156491 ↗
  • InjuryJul 13, 2021Fracture; 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 THREE YEARS POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE NEAR CONNECTION TO THE PORT STEM AND MIGRATED INTO HEART. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AND CATHETER WAS REMOVED FORM THE BODY. PATIENT REPORTED STABLE.

    Patient problems: Discomfort; Embolism/Embolus; Pain

    MAUDE report 12156355 ↗
  • InjuryMar 5, 2021Fracture; Failure to Infuse; Migration; Fracture; Failure to Infuse; Migration

    IT WAS REPORTED THAT POST PORT DEVICE IMPLANT IN THE RIGHT SUBCLAVIAN VEIN, THE DEVICE ALLEGEDLY STOPPED WORKING AND WAS REPLACED WITH ANOTHER DEVICE. IT WAS FURTHER REPORTED THAT THE FRONT PART OF THE FLOW SYSTEM WAS FOUND TO BE MISSING AND WAS FOUND TO BE MIGRATED UNDER CT SCAN. ADDITIONAL INTERVENTION WAS UNDER GONE TO RECOVER THE DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 11419872 ↗
  • InjuryJan 6, 2021Fracture; Migration; Fracture; Migration

    IT WAS REPORTED THAT POST PORT DEVICE EXPLANT FROM THE RIGHT SUBCLAVIAN VEIN AND UPON CT SCAN ANALYSIS, PARTS OF THE CATHETER WAS ALLEGEDLY FOUND TO HAVE BEEN BROKEN AND MIGRATED INTO THE PULMONARY ARTERY. THE PORT WAS REPORTED TO BE REMOVED AND REPLACED WITH ANOTHER DEVICE. 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 11121971 ↗
  • InjurySep 29, 2020Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

    IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND TO HAVE BROKEN AND DISLODGED INTO THE PULMONARY ARTERY. ATTEMPT TO RETRIEVE THE DEVICE WAS PERFORMED BUT RESULTED IN FAILURE. THE CATHETER WAS REPORTED TO BE FINALLY REMOVED THROUGH CARDIOTHORACIC SURGERY. THE PATIENT STATUS IS UNKNOWN.

    Patient problems: Foreign Body In Patient

    MAUDE report 10598200 ↗
  • InjuryJun 6, 2019Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT SOME TIME POST PORT CATHETER PLACEMENT IN THE LEFT JUGULAR VEIN THROUGH INFRACLAVICULAR INCISION, AN X-RAY ALLEGED REVEALED CATHETER INFILTRATION. REPORTEDLY, AN ADDITIONAL INTERVENTION WAS REQUIRED FOR REMOVAL AND REPLACEMENT OF THE DEVICE. THE PATIENT WAS REPORTEDLY STABLE AFTER THE REMOVAL AND REPLACEMENT OF THE DEVICE.

    Patient problems: Infiltration into Tissue

    MAUDE report 8675396 ↗
  • InjuryAug 10, 2018Break; Break

    IT WAS REPORTED THAT APPROXIMATELY ELEVEN MONTHS AFTER PLACEMENT OF THE DEVICE; THE DEVICE ALLEGEDLY BROKE AND MIGRATED TO THE PULMONARY ARTERY. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7772483 ↗

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Sources and updates

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