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PowerPort M.R.I. 1859600Recalls & reported problems

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

All models of PowerPort M.R.I. (8)

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

Quick summary

This Bard PowerPort is an implantable port with a catheter placed under the skin to access a vein. The 42 reports mostly describe infections and blood clots after placement, with some mentioning the catheter breaking, separating or leaking. The reports mention 1 death and 31 injuries. No recalls name this device, and reports fell from 18 to 9 in the past year.

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
42
Deaths reported
1
Injuries reported
31
Recalls naming it
0

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741027208), received between Oct 18, 2019 and Jul 29, 2026 — classified as 1 death, 31 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 2 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 3 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 4 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 4 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 4 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem23
  • Fracture13
  • Material Separation6
  • Fluid/Blood Leak4
  • Premature Separation3
  • Reflux within Device3
  • Loss of or Failure to Bond2
  • Migration2

Patient problems

  • Unspecified Infection18
  • Thrombosis/Thrombus13
  • No Clinical Signs, Symptoms or Conditions9
  • Pain5
  • Bacteremia3
  • Sepsis3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Bacterial Infection2

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

    It was reported through the litigation process that, on (b)(6) 2014, a patient underwent port placement via the right internal jugular vein for the treatment of B cell lymphoma. Approximately two days later, on (b)(6) 2014, the patient experienced bruising at the port site. Additionally, approximately two days later, on (b)(6) 2014, hematoma was observed around the insertion site. Subsequently, the port was removed on (b)(6) 2015. However, the current status of the patient remains unknown.

    Patient problems: Bruise/Contusion; Hematoma

    MAUDE report 50067080 ↗
  • InjuryApr 13, 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 AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 24863007 ↗
  • InjuryMar 16, 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 AND NECROSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Necrosis; Unspecified Infection

    MAUDE report 24604472 ↗
  • InjuryMar 16, 2026Obstruction of Flow

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

    Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

    MAUDE report 24603010 ↗
  • InjuryMar 5, 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 IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 24516413 ↗
  • InjuryMar 5, 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 IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 24516310 ↗
  • DeathDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED DURING THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23920580 ↗
  • InjuryDec 25, 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, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23892347 ↗
  • InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY FOUR MONTHS, TWO WEEKS AND ONE DAY POST A PORT PLACEMENT PROCEDURE VIA THE RIGHT SUBCLAVIAN VEIN FOR LONG TERM TOTAL PARENTERAL NUTRITION, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND SEPSIS. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED AND A NEW PORT WAS IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Sepsis; Unspecified Infection

    MAUDE report 23450237 ↗
  • MalfunctionOct 31, 2025Fracture; Fracture

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23434368 ↗
  • InjurySep 18, 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 BLOOD CLOT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 23081696 ↗
  • MalfunctionAug 26, 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 22892472 ↗
  • MalfunctionAug 19, 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 22839294 ↗
  • InjuryAug 18, 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 22836348 ↗
  • MalfunctionAug 8, 2025Fracture; Fracture

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22748978 ↗
  • InjuryJul 29, 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 WAS ALLEGEDLY DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 22641612 ↗
  • InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH BACK PAIN AND THROMBUS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Pain; Thrombosis/Thrombus

    MAUDE report 22574237 ↗
  • InjuryJul 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 22476963 ↗
  • InjuryMay 7, 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 A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 21977217 ↗
  • InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2020, PATIENT UNDERWENT BARD BARDPORT M.R.I. IMPLANTABLE PORT PLACEMENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION. ABOUT SOMETIME POST A PORT PLACEMENT, PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 21916481 ↗
  • InjuryApr 2, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER ALLEGEDLY DEVELOPED WITH FRACTURE AND FLUID LEAK. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED PAIN, UNSPECIFIED INFECTION, THROMBOSIS AND THROMBUS FORMATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Pain; Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 21751330 ↗
  • InjuryApr 2, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER ALLEGEDLY DEVELOPED WITH FRACTURE AND FLUID LEAK. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED PAIN, UNSPECIFIED INFECTION, THROMBOSIS AND THROMBUS FORMATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Pain; Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 21751012 ↗
  • InjuryApr 2, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER ALLEGEDLY DEVELOPED WITH FRACTURE AND FLUID LEAK. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED PAIN, UNSPECIFIED INFECTION, THROMBOSIS AND THROMBUS FORMATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Pain; Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 21750829 ↗
  • MalfunctionDec 19, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT PROCEDURE, IT WAS NOTED THAT THE EXPIRED PRODUCT WAS IMPLANTED ON PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20974731 ↗
  • InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Sepsis; Unspecified Infection

    MAUDE report 20731825 ↗

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Sources and updates

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