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PowerPort 1759600Recalls & reported problems

Bard Access Systems, Inc. · PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs) · Class 2 · Implant

Adverse event reports
11
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741026850), received between Nov 9, 2018 and Aug 10, 2026 — classified as 8 injuries, 3 malfunctions.

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. How this data works · Data updated Oct 13, 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: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem7
  • Fracture3
  • Material Separation2
  • Device Dislodged or Dislocated1
  • Migration1

Patient problems

  • Unspecified Infection5
  • No Clinical Signs, Symptoms or Conditions2
  • Thrombosis/Thrombus2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Arrhythmia1
  • Bruise/Contusion1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

    It was reported through litigation process that sometime later post port placement procedure via the right jugular vein, the patient was diagnosed with an unspecified infection. However, the current status of the patient is unknown.

    Patient problems: Unspecified Infection

    MAUDE report 50190900 ↗
  • InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 24965404 ↗
  • MalfunctionMar 13, 2026Fracture

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24597289 ↗
  • InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23753815 ↗
  • InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23753814 ↗
  • InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 23277005 ↗
  • InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23034992 ↗
  • InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 21467802 ↗
  • MalfunctionJul 23, 2024Fracture; Material Separation; Fracture; Material Separation

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE STRAIGHT HUBER NEEDLE IN THE DEVICE WAS ALLEGEDLY FOUND TO BE VERY FRAGILE AND SNAPPED OFF FROM THE HUB ITSELF. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19804080 ↗
  • InjuryJul 25, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT FIVE MONTHS AND SEVENTEEN DAYS POST PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN, THE PORT WAS ALLEGEDLY FOUND TO BE FRACTURED. IT WAS FURTHER REPORTED THAT A PIECE HAD BROKEN OFF AND MIGRATED TO THE PATIENT'S HEART. FURTHERMORE, ATTEMPTS WERE MADE TO REMOVE THE FRACTURED PIECE AND THE REST OF THE REMAINING PRODUCT BUT WERE UNSUCCESSFUL IN REMOVING THE DEFECTIVE DEVICE IN ITS ENTIRETY DUE TO THE DEVELOPING HEART ARRHYTHMIAS DURING THE PROCEDURE. REPORTEDLY, ADDITIONAL SURGERY WAS DONE TO REMOVE THE FRACTURED CATHETER PIECE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

    MAUDE report 17389414 ↗
  • MalfunctionNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING CHEMOTHERAPY TREATMENT, THE PATIENT PORT ALLEGEDLY FLIPPED AND WAS MANUALLY ROTATED BY THE HEALTH CARE PROVIDER. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Bruise/Contusion

    MAUDE report 8057104 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.