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X-Port isp M.R.I., Groshong 7757540Recalls & reported problems

Bard Access Systems, Inc. · X-Port isp M.R.I. Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter Microintroducer Kit · Class 2 · Implant

All models of X-Port isp M.R.I., Groshong (2)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741027505), received between Oct 18, 2019 and Nov 10, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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

  • Defective Component1
  • Detachment of Device or Device Component1
  • Difficult to Flush1
  • Disconnection1
  • Fracture1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionNov 10, 2022Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

    IT WAS REPORTED THAT SEVEN YEARS POST PORT PLACEMENT PROCEDURE, THE RADIOPAQUE STRIPE WAS ALLEGEDLY SEPARATED FROM CATHETER. THE PORT WAS REMOVED, AND THE PORT POCKET WAS CLOSED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15769001 ↗
  • InjuryApr 15, 2021Difficult to Flush; Fracture; Difficult to Flush; Fracture

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS 7 MONTHS POST PORT PLACEMENT, THE PORT ALLEGEDLY STOPPED FLUSHING. IT WAS FURTHER REPORTED THAT ADDITIONAL SURGERY WAS CONDUCTED TO REMOVE THE PORT. REPORTEDLY DURING REMOVAL PROCEDURE, THE CATHETER ALLEGEDLY BROKEN, THE PROXIMAL END OF THE CATHETER WAS RETRACTED WITH THE TIP OF THE CATHETER BEING OBTAINED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. PATIENT STATUS WAS UNKNOWN.

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

    MAUDE report 11670562 ↗
  • MalfunctionOct 18, 2019Defective Component; Defective Component

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7757540 PORT & CATHETER ALLEGEDLY HAD A DEFECTIVE COMPONENT. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 9211278 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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Sources and updates

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