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PowerPort M.R.I., ChronoFlex 1808069Recalls & reported problems

Bard Access Systems, Inc. · PowerPort isp M.R.I. Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs) · Class 2 · Implant

All models of PowerPort M.R.I., ChronoFlex (22)

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

Quick summary

This Bard PowerPort implantable port, used with a ChronoFlex catheter, sits under the skin to deliver medicines and draw blood. The 43 reports mostly describe infections at the port site or in the bloodstream, along with blood clots forming in the catheter, skin breakdown over the port, and ports that were expelled or hard to flush. Five reports describe a death and 31 an injury; in the death reports the cause was not given. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
41
Deaths reported
4
Injuries reported
30
Recalls naming it
0

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741027062), received between Apr 17, 2019 and Sep 25, 2026 — classified as 4 deaths, 30 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 2 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 3 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 3 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 2 reportsOct 2025: 5 reportsNov 2025: 2 reportsDec 2025: 3 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem28
  • Expulsion3
  • Obstruction of Flow3
  • Device Appears to Trigger Rejection2
  • Difficult to Flush2
  • Fracture2
  • Migration2
  • Suction Problem2

Patient problems

  • Unspecified Infection26
  • No Consequences Or Impact To Patient5
  • Skin Erosion3
  • Thrombosis/Thrombus3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • No Clinical Signs, Symptoms or Conditions2
  • Pain2
  • Sepsis2

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

  • InjurySep 25, 2026Fracture; Material Separation; Migration

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

    MAUDE report 50896667 ↗
  • InjuryMay 28, 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 25312349 ↗
  • InjuryMar 26, 2026Device Appears to Trigger Rejection; Obstruction of Flow

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND OCCLUSION. ADDITIONALLY, FIBRIN SHEATH FORMATION WAS OBSERVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Obstruction/Occlusion; Unspecified Infection

    MAUDE report 24698665 ↗
  • DeathFeb 12, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 24320962 ↗
  • InjuryJan 19, 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 IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 24107033 ↗
  • DeathDec 30, 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 23919800 ↗
  • InjuryDec 25, 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 IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23891716 ↗
  • InjuryDec 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 AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23886700 ↗
  • InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23654063 ↗
  • InjuryNov 5, 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 23473954 ↗
  • InjuryOct 30, 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 23423564 ↗
  • InjuryOct 30, 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 23423258 ↗
  • MalfunctionOct 23, 2025Obstruction of Flow; Migration; Obstruction of Flow; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, CATH LUMEN OCCLUSION AND MIGRATION WERE OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23364999 ↗
  • InjuryOct 17, 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 23321016 ↗
  • InjuryOct 16, 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 23312380 ↗
  • DeathSep 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 AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

    Patient problems: Unspecified Infection

    MAUDE report 23012632 ↗
  • InjurySep 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 22951029 ↗
  • 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 DEVELOPED PAIN AT PORT SITE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Pain

    MAUDE report 22780337 ↗
  • InjuryJul 29, 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 SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Sepsis

    MAUDE report 22640623 ↗
  • InjuryJun 26, 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 POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 22335241 ↗
  • InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22334221 ↗
  • InjuryJun 16, 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 POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22209568 ↗
  • InjuryMay 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 AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22001284 ↗
  • InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017, PATIENT UNDERWENT BARD POWERPORT ISP M.R.I. IMPLANTABLE PORT PLACEMENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION. ABOUT SOMETIME AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 21983750 ↗
  • DeathMar 17, 2025Expulsion; Expulsion

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2012, A PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN FOR THE TREATMENT OF CHRONIC LYMPHOID LEUKEMIA. APPROXIMATELY TWO MONTHS AND FOUR DAYS LATER, ON (B)(6) 2012, THE PATIENT EXPERIENCED EROSION AT THE PORT BODY SITE. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6) 2012. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

    Patient problems: Insufficient Information; Skin Erosion

    MAUDE report 21616924 ↗

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Sources and updates

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