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PowerPort, ChronoFlex 1708062Recalls & reported problems

Bard Access Systems, Inc. · PowerPort Vue Titanium Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Intermediate Kit · Class 2 · Implant

All models of PowerPort, ChronoFlex (16)

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

Adverse event reports
17
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741026645), received between Jul 3, 2018 and Dec 23, 2025 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (4 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: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 2 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 2 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

  • Adverse Event Without Identified Device or Use Problem12
  • Difficult to Flush4
  • Fluid/Blood Leak2
  • Flushing Problem1
  • Fracture1
  • Material Protrusion/Extrusion1
  • Obstruction of Flow1
  • Suction Problem1

Patient problems

  • Unspecified Infection11
  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2
  • Bruise/Contusion1
  • Erythema1
  • Extravasation1
  • Pain1
  • Thrombosis/Thrombus1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 23, 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 WAS DIAGNOSED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23875374 ↗
  • InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23567572 ↗
  • InjuryNov 14, 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 23551415 ↗
  • InjuryOct 31, 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 23434627 ↗
  • InjurySep 8, 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 22990075 ↗
  • InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, ON (B)(6) 2019, A PATIENT UNDERWENT RIGHT SIDED PORT PLACEMENT, USING BARD POWERPORT VUE TITANIUM IMPLANTABLE PORT CATHETER, FOR LONG TERM INTRAVENOUS THERAPY AND BLOOD TRANSFUSIONS. APPROXIMATELY THREE MONTHS AND THIRTY DAYS LATER, ON (B)(6) 2019, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6) 2019. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22862705 ↗
  • InjuryAug 3, 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 22696297 ↗
  • InjuryJul 28, 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 22628464 ↗
  • InjuryJul 24, 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 22586503 ↗
  • InjuryJun 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 WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22165498 ↗
  • InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON N(B)(6) 2018, PATIENT UNDERWENT BARD POWERPORT VUE TITANIUM IMPLANTABLE PORT PLACEMENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION. ABOUT SOMETIME POST A PORT PLACEMENT, PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 21916405 ↗
  • MalfunctionFeb 21, 2025Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

    IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT PROCEDURE THE PORT ALLEGEDLY UNABLE TO FLUSH OR ASPIRATE. IT WAS FURTHER REPORTED THAT PORT FUNCTION GRADUALLY DETERIORATED OVER SEVERAL MONTHS UNTIL IT WOULD NO LONGER FLUSH. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21431108 ↗
  • MalfunctionJan 20, 2025Fracture; Fluid/Blood Leak; Difficult to Flush; Fracture

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

    Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21189613 ↗
  • InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 21122402 ↗
  • MalfunctionJan 22, 2021Difficult to Flush; Flushing Problem; Difficult to Flush; Flushing Problem

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1708062 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED DIFFICULT TO FLUSH AND FLUSHING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11216785 ↗
  • MalfunctionJul 15, 2020Difficult to Flush; Obstruction of Flow; Material Protrusion/Extrusion; Difficult to Flush; Obstruction of Flow; Material Protrusion/Extrusion

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1708062 IMPLANTED PORTS ALLEGEDLY EXPERIENCED OBSTRUCTION OF FLOW. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT WAS A FEMALE; HOWEVER, THE AGE AND WEIGHT WAS NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10280478 ↗
  • MalfunctionJul 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED SWELLING, DISCOLORATION AND/OR BRUISING OF THE PORT SITE AFTER THE PORT SITE WAS DE-ACCESSED. THE HEALTH CARE PROVIDER DISCUSSED WITH THE PATIENT THAT THE DISCOLORATION WAS LEAKAGE OF BODY FLUIDS UNDERNEATH THE SKIN. THE PATIENT WAS TOLD TO LEAVE THE AREA ALONE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Bruise/Contusion; Erythema; Pain

    MAUDE report 7660908 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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Sources and updates

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