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
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 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page