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PowerPort, ChronoFlex 1706061Recalls & reported problems

Bard Access Systems, Inc. · PowerPort isp Implantable Port with Attachable 6F ChronoFlex Open-Ended Single-Lumen Venous Catheter. Intermediate Kit (without Suture Plug) · Class 2 · Implant

All models of PowerPort, ChronoFlex (16)

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

Adverse event reports
11
Deaths reported
2
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741026553), received between Aug 29, 2019 and Sep 28, 2026 — classified as 2 deaths, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 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: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 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 Problem5
  • Migration2
  • Appropriate Device Problem Term/Code Not Available1
  • Device Appears to Trigger Rejection1
  • Difficult to Flush1
  • Expulsion1
  • Fracture1
  • Obstruction of Flow1

Patient problems

  • Unspecified Infection4
  • Thrombosis/Thrombus3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Sepsis2
  • Skin Erosion2
  • Bacterial Infection1
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjurySep 28, 2026Expulsion

    It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection, erosion and wound complications. However, the current status of the patient was unknown.

    Patient problems: Skin Erosion; Unspecified Infection

    MAUDE report 50911165 ↗
  • InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Thrombosis/Thrombus

    MAUDE report 24659470 ↗
  • MalfunctionNov 7, 2025Fracture; Fracture

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23494409 ↗
  • InjuryAug 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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 22781528 ↗
  • InjuryAug 11, 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 22768891 ↗
  • InjuryJun 10, 2024Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THREE MONTHS AND FOUR DAYS POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY MIGRATED THE PATIENT REPORTEDLY DIAGNOSED WITH FIBRIN SHEATH FORMATION AROUND THE TIP OF THE PORT CATHETER. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS, INFECTION AND SEPSIS. REPORTEDLY, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Sepsis; Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 19496744 ↗
  • DeathMay 23, 2024Difficult to Flush; Suction Problem; Migration; Difficult to Flush; Suction Problem; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT FOUR DAYS POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY NON-FUNCTIONAL. IT WAS FURTHER REPORTED THAT THE PORT HAD ALLEGEDLY MIGRATED. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. EVIDENTLY, THE PATIENT WAS EXPIRED, AND PRIMARY CAUSE OF DEATH WAS NOT PROVIDED, AND THE RELATIONSHIP OF DEATH WITH THE DEVICE WAS NOT PROVIDED.

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

    MAUDE report 19379049 ↗
  • DeathApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO MONTHS AND NINE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH CLOSTRIDIUM DIFFICILE INFECTION RELATED TO THE PORT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH SEVERE SEPSIS AND EXPERIENCED SEPTIC SHOCK. REPORTEDLY, THE INFECTED PORT WAS REMOVED. EVIDENTLY, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Sepsis; Septic Shock; Unspecified Infection

    MAUDE report 19030604 ↗
  • InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT ALLEGEDLY HAD PAIN IN THE RIGHT CHEST AND ARM. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SWELLING AND DIFFICULTY SWALLOWING. THE PATIENT CURRENT STATUS WAS UNKNOWN.

    Patient problems: Pain; Swelling/ Edema

    MAUDE report 11145574 ↗
  • MalfunctionApr 14, 2020Obstruction of Flow; Obstruction of Flow

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1706061 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED OBSTRUCTION OF FLOW. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) FEMALE. WEIGHT INFORMATION WAS NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9960519 ↗
  • InjuryAug 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT, THE PORT ALLEGEDLY ERODED THROUGH THE SKIN. REPORTEDLY, THE PATIENT IS SCHEDULED FOR PORT DEVICE REPLACEMENT. THE PATIENT'S STATUS IS REPORTED AS STABLE.

    Patient problems: Skin Erosion

    MAUDE report 8944445 ↗

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Sources and updates

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