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BardPort M.R.I., Groshong 0605920Recalls & reported problems

Bard Access Systems, Inc. · BardPort M.R.I. Dual-Lumen Implantable Port with Attachable 9.5F Groshong Dual-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
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741026027), received between Oct 4, 2021 and Sep 5, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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

Device problems

  • Device Appears to Trigger Rejection2
  • Difficult to Flush2
  • Fluid/Blood Leak2
  • Suction Problem2
  • Fracture1
  • Material Separation1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Extravasation2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 5, 2023Fluid/Blood Leak; Difficult to Flush; Device Appears to Trigger Rejection; Suction Problem; Fluid/Blood Leak; Difficult to Flush; Device Appears to Trigger Rejection; Suction Problem

    IT WAS REPORTED THAT ONE WEEK FOUR DAYS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD EXTRAVASATION OF CHEMOTHERAPY. IT WAS FURTHER REPORTED THAT CATHETER OF THE PORT HAD A LARGE FIBRIN SHEATH THAT WRAPPED AROUND THE CATHETER AND EXTENDED OVER THE TIP. IT WAS ALSO REPORTED THAT THE DEVICE ALLEGEDLY HAD SUCTION ISSUE AND WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 17681453 ↗
  • InjurySep 5, 2023Fluid/Blood Leak; Difficult to Flush; Device Appears to Trigger Rejection; Suction Problem; Fluid/Blood Leak; Difficult to Flush; Device Appears to Trigger Rejection; Suction Problem

    IT WAS REPORTED THAT TWENTY FIVE DAYS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD EXTRAVASATION OF CHEMOTHERAPY. IT WAS FURTHER REPORTED THAT CATHETER OF THE PORT HAD A LARGE FIBRIN SHEATH THAT WRAPPED AROUND THE CATHETER AND EXTENDED OVER THE TIP. IT WAS ALSO REPORTED THAT THE DEVICE ALLEGEDLY HAD SUCTION ISSUE AND DIFFICULT TO BE FLUSHED. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 17681450 ↗
  • MalfunctionOct 4, 2021Fracture; Material Separation; Fracture; Material Separation

    IT WAS REPORTED THAT THE CUFF OF THE DEVICE ALLEGEDLY BROKE WHILE REMOVING THE DUAL LUMEN MEDIPORT. REPORTEDLY, ALL THE BROKEN PIECES OF THE DEVICE WERE RETRIEVED. THERE IS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12567202 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

All PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices →

Sources and updates

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