Skip to content

PowerPort M.R.I., Groshong 1878001Recalls & reported problems

Bard Access Systems, Inc. · PowerPort M.R.I. Implantable Port with Attachable 8F Groshong Single-Lumen Venous Catheter. Intermediate Kit (without Suture Plugs) · Class 2 · Implant

All models of PowerPort M.R.I., Groshong (10)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741027253), received between Aug 31, 2020 and Dec 13, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (3 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: 0 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: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 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

  • Fracture3
  • Material Separation3
  • Migration3
  • Adverse Event Without Identified Device or Use Problem2
  • Device Dislodged or Dislocated1
  • Difficult to Remove1
  • Material Twisted/Bent1
  • Migration or Expulsion of Device1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Burning Sensation1
  • Chest Pain1
  • Embolism/Embolus1
  • Hemoptysis1
  • Injury1
  • Itching Sensation1
  • Myocardial Infarction1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION AND STROKE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Stroke/CVA; Unspecified Infection

    MAUDE report 23797152 ↗
  • InjuryApr 29, 2024Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT A PORT WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH BREAST CANCER. IT WAS FURTHER REPORTED THAT ONE YEAR, FOUR MONTHS AND FIVE DAYS POST A PORT PLACEMENT VIA THE RIGHT JUGULAR VEIN APPROACH, THE CATHETER WAS ALLEGEDLY FRACTURED AT THE PROXIMAL ONE BY THIRD LEVEL AND THE DISTAL TWO THIRD OF THE CATHETER WAS ALLEGEDLY VISUALIZED IN THE RIGHT HEART. FURTHERMORE, THE PATIENT UNDERWENT ATTEMPTED REMOVAL OF FOREIGN OBJECT AND THE LONGER SHEATH WAS ADVANCED THE SNARE UNDER FLUOROSCOPY GUIDANCE MODERATELY ATTEMPT TO SNARE THE CATHETER WAS UNSUCCESSFUL. PATIENT WAS REFERRED TO SURGERY. PATIENT UNDERWENT REMOVAL OF PORT AND REMOVAL OF INTRACARDIAC FOREIGN BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 19199425 ↗
  • InjuryApr 4, 2024Fracture; Material Separation; Material Twisted/Bent; Migration; Fracture; Material Separation; Material Twisted/Bent; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE AND THE DISTAL CATHETER FRAGMENT ALLEGEDLY COILED. IT WAS FURTHER REPORTED THAT THE DISLODGED CATHETER WAS IN RIGHT ATRIUM. FURTHERMORE, THE PATIENT ALLEGEDLY DEVELOPED PULMONARY EMBOLISM AND MYOCARDIAL INFARCTION. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Myocardial Infarction; Pulmonary Embolism

    MAUDE report 19039906 ↗
  • InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY TWO DAYS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED RASHES. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED ITCHING. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Itching Sensation; Rash

    MAUDE report 17265825 ↗
  • InjuryAug 31, 2020Fracture; Migration or Expulsion of Device; Material Separation; Device Dislodged or Dislocated; Migration; Fracture; Migration or Expulsion of Device; Material Separation; Device Dislodged or Dislocated; Migration

    IT WAS REPORTED THAT AFTER PORT PLACEMENT, THE CATHETER ALLEGEDLY DISLODGED FROM THE PORT AND MIGRATED TO THE HEART. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED HEART ATTACK AND UNDERWENT SURGERY. THE PATIENT CURRENT STATUS IS UNKNOWN.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Embolism/Embolus; Hemoptysis; Injury

    MAUDE report 10470589 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page