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PowerPort 1759601Recalls & reported problems

Bard Access Systems, Inc. · PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter Intermediate Kit (without Suture Plugs) · Class 2 · Implant

All models of PowerPort (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
1
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741026867), received between Apr 26, 2023 and Nov 29, 2024 — classified as 1 death, 3 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 2 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: 0 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
  • Difficult to Remove2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
  • Foreign Body In Patient1
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 29, 2024Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT ALLEGEDLY DEVELOPED WITH CATHETER FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

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

    MAUDE report 20810674 ↗
  • InjuryNov 27, 2024Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, NINE MONTHS AND SEVEN DAYS LATER PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED AND THE CATHETER FRAGMENT MIGRATED TO LUNG. THE CATHETER FRAGMENT WAS UNABLE TO BE RETRIEVED BECAUSE IT HAD TRAVELLED TO PATIENT'S PULMONARY ARTERY. THE PATIENT WAS THEN TRANSFERRED TO INTERVENTIONAL RADIOLOGY, WHERE MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE CATHETER FRAGMENT THROUGH GROIN. ONE DAY LATER, ADDITIONAL PROCEDURES WERE CARRIED AND THE CATHETER FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S PULMONARY ARTERY VIA GROIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 20794668 ↗
  • InjurySep 17, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY HAD FRACTURED. IT WAS FURTHER REPORTED THAT THE FRACTURED CATHETER MIGRATED INTO THE RIGHT VENTRICLE. REPORTEDLY, THE PORT WAS REMOVED AND FRACTURED CATHETER REMAINS IN PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

    MAUDE report 20234833 ↗
  • DeathApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPIRED WHILE USING A PORT DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENTS CAUSE OF DEATH IS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 16813388 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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

Sources and updates

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