PowerPort M.R.I. 1859601Recalls & 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 (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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741027215), received between Sep 2, 2025 and Sep 29, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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 Problem10
- Fracture1
Patient problems
- Unspecified Infection9
- Thrombosis/Thrombus4
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 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 50928171 ↗InjuryApr 29, 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 REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 25024532 ↗InjuryApr 23, 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 BLOOD CLOTS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 24964392 ↗InjuryApr 20, 2026Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24924123 ↗InjuryApr 17, 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 REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24907948 ↗InjuryMar 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24587835 ↗InjuryNov 6, 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 23484858 ↗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 23474796 ↗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 23474787 ↗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 23474569 ↗InjurySep 2, 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 22931468 ↗
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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