Skip to content

PowerPort M.R.I. 1809601Recalls & reported problems

Bard Access Systems, Inc. · PowerPort M.R.I. Implantable Port with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter Intermediate Kit (without Suture Plugs) · Class 2 · Implant

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

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

Adverse event reports
20
Deaths reported
2
Injuries reported
14
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741027147), received between Jul 21, 2020 and Jul 3, 2026 — classified as 2 deaths, 14 injuries, 4 malfunctions.

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

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 3 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem14
  • Fracture4
  • Device Appears to Trigger Rejection2
  • Migration2
  • Obstruction of Flow2
  • Component Missing1
  • Material Protrusion/Extrusion1
  • Material Separation1

Patient problems

  • Unspecified Infection11
  • Thrombosis/Thrombus5
  • No Clinical Signs, Symptoms or Conditions3
  • Pulmonary Embolism2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Bacterial Infection1
  • Cellulitis1
  • Erythema1

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 3, 2026Device Appears to Trigger Rejection; Obstruction of Flow; Material Protrusion/Extrusion; Migration

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER AND PORT BODY AND RESERVOIR ALLEGEDLY BECAME OCCLUDED. ADDITIONALLY, PROTRUSION AND MIGRATION WERE OBSERVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

    Patient problems: Thrombosis/Thrombus

    MAUDE report 25700990 ↗
  • DeathMar 30, 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 24710699 ↗
  • InjuryMar 11, 2026Device Appears to Trigger Rejection; 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 THROMBOSIS AND PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

    MAUDE report 24566146 ↗
  • InjuryMar 9, 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 24544351 ↗
  • MalfunctionFeb 19, 2026Fracture

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24386551 ↗
  • InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, TWENTY-ONE DAYS, AFTER THE PORT PLACEMENT VIA INTERNAL JUGULAR VEIN FOR THE NEED OF LONG-TERM IV THERAPY AND BLOOD TRANSFUSIONS, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 24036404 ↗
  • InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, TWO MONTHS AND TWENTY-SEVEN DAYS OF PORT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN FOR THE NEED OF LONG-TERM IV THERAPY AND BLOOD TRANSFUSIONS, THE PATIENT WAS DIAGNOSED WITH AN INFECTED PORT. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 24036204 ↗
  • InjuryNov 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 PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23643546 ↗
  • InjuryNov 20, 2025Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY HAD FRACTURED. PATIENT WAS DIAGNOSED WITH THROMBOSIS AND OCCLUSION OF THE THROMBUS. THE CURRENT STATUS OF PATIENT WAS UNKNOWN.

    Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

    MAUDE report 23602159 ↗
  • InjuryNov 13, 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 INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 23540274 ↗
  • DeathOct 6, 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 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 23219120 ↗
  • 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), 2021, A PATIENT UNDERWENT RIGHT SIDED PORT PLACEMENT, USING A BARD POWERPORT MRI IMPLANTABLE PORT CATHETER, FOR LONG TERM INTRAVENOUS THERAPY AND BLOOD TRANSFUSIONS. APPROXIMATELY ONE YEAR, FIVE MONTHS AND FIVE DAYS LATER, ON (B)(6), 2023, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6), 2023. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 22861749 ↗
  • MalfunctionApr 5, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A PORT PLACEMENT, WHEN CONNECT THE CATHETER TO THE PORT THE SILICONE CATHETER ALLEGEDLY BROKEN AT THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21781100 ↗
  • InjuryMar 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 ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 21615730 ↗
  • InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Thrombosis/Thrombus; Unspecified Infection

    MAUDE report 20608374 ↗
  • InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH AND TWENTY DAYS POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH ERYTHEMA. IT WAS FURTHER REPORTED THAT PATIENT WAS DIAGNOSED WITH BACTERIAL INFECTION AND CELLULITIS. REPORTEDLY, THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Patient problems: Bacterial Infection; Cellulitis; Erythema; Unspecified Infection

    MAUDE report 19761334 ↗
  • InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO WEEKS AND SIX DAYS POST A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS AND MASSIVE PULMONARY EMBOLISM. REPORTEDLY, PATIENT UNDERWENT EXTENSIVE SURGERY TO REMOVE THE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

    MAUDE report 18189245 ↗
  • InjuryOct 21, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR TWO MONTHS FROM PORT PLACEMENT PROCEDURE FOR CHEMOTHERAPY TREATMENT, THE PORT WAS ALLEGEDLY NO LONGER FUNCTIONED. IT WAS FURTHER REPORTED THE CATHETER FRAGMENT WAS DIAGNOSED IN PATIENTS HEART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

    MAUDE report 17982134 ↗
  • MalfunctionMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD PAINS AND SPASMS IN HER NECK THAT RADIATE UP INTO HER JAW AND TONGUE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16495788 ↗
  • MalfunctionJul 21, 2020Component Missing; Component Missing

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1809601 IMPLANTABLE PORT ALLEGEDLY WAS MISSING CATHETER. THIS INFORMATION WAS RECEIVED FROM (B)(6). OF THE ONE MALFUNCTION, THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCES. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 10303363 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page