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
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 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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