PowerPort 1759600Recalls & reported problems
Bard Access Systems, Inc. · PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs) · Class 2 · Implant
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741026850), received between Nov 9, 2018 and Aug 10, 2026 — classified as 8 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Fracture3
- Material Separation2
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- Unspecified Infection5
- No Clinical Signs, Symptoms or Conditions2
- Thrombosis/Thrombus2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Arrhythmia1
- Bruise/Contusion1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported through litigation process that sometime later post port placement procedure via the right jugular vein, the patient was diagnosed with an unspecified infection. However, the current status of the patient is unknown.
Patient problems: Unspecified Infection
MAUDE report 50190900 ↗InjuryApr 23, 2026Adverse 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24965404 ↗MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597289 ↗InjuryDec 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 23753815 ↗InjuryDec 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 23753814 ↗InjuryOct 15, 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 AND PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23277005 ↗InjurySep 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 WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23034992 ↗InjuryFeb 26, 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 21467802 ↗MalfunctionJul 23, 2024Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE STRAIGHT HUBER NEEDLE IN THE DEVICE WAS ALLEGEDLY FOUND TO BE VERY FRAGILE AND SNAPPED OFF FROM THE HUB ITSELF. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804080 ↗InjuryJul 25, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT FIVE MONTHS AND SEVENTEEN DAYS POST PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN, THE PORT WAS ALLEGEDLY FOUND TO BE FRACTURED. IT WAS FURTHER REPORTED THAT A PIECE HAD BROKEN OFF AND MIGRATED TO THE PATIENT'S HEART. FURTHERMORE, ATTEMPTS WERE MADE TO REMOVE THE FRACTURED PIECE AND THE REST OF THE REMAINING PRODUCT BUT WERE UNSUCCESSFUL IN REMOVING THE DEFECTIVE DEVICE IN ITS ENTIRETY DUE TO THE DEVELOPING HEART ARRHYTHMIAS DURING THE PROCEDURE. REPORTEDLY, ADDITIONAL SURGERY WAS DONE TO REMOVE THE FRACTURED CATHETER PIECE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia
MAUDE report 17389414 ↗MalfunctionNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING CHEMOTHERAPY TREATMENT, THE PATIENT PORT ALLEGEDLY FLIPPED AND WAS MANUALLY ROTATED BY THE HEALTH CARE PROVIDER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Bruise/Contusion
MAUDE report 8057104 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
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- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.