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PowerPort, ChronoFlex 1706050Recalls & reported problems

Bard Access Systems, Inc. · PowerPort isp Implantable Port with Attachable 6F ChronoFlex Open-Ended Single-Lumen Venous Catheter. Microintroducer Kit (with 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
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741026515), received between Jul 1, 2021 and Aug 10, 2024 — classified as 4 injuries.

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: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 2 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: 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

  • Adverse Event Without Identified Device or Use Problem4

Patient problems

  • Pain2
  • Bacteremia1
  • Bacterial Infection1
  • Sepsis1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY ELEVEN MONTHS AND SEVEN DAYS POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED WITH BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED WITH BACTEREMIA AND SEPSIS AS A RESULT OF THE DEFECTIVE INFECTED PORT. REPORTEDLY, THE DEFECTIVE INFECTED PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Bacteremia; Bacterial Infection; Sepsis

    MAUDE report 19957022 ↗
  • InjuryAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 19956940 ↗
  • InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED PAIN THAT GOES DOWN INTO CHEST AND INTO NIPPLE. THE PATIENT CURRENT STATUS IS UNKNOWN.

    Patient problems: Pain

    MAUDE report 12438579 ↗
  • InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SIX YEARS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY FELT PINS AND NEEDLES SENSATION THAT GOES UP INTO THE NECK AND EXPERIENCED HEADACHE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED ON LATER DAYS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT CURRENT STATUS IS UNKNOWN.

    Patient problems: Pain

    MAUDE report 12098139 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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

Sources and updates

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