PowerPort 1716071Recalls & reported problems
Bard Access Systems, Inc. · PowerPort Slim Implantable Port with Attachable 6F Polyurethane Open-Ended Single-Lumen Venous Catheter MicroIntroducer Kit (without Suture Plugs) · Class 2 · Implant
All models of PowerPort (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741026775), received between Jan 2, 2019 and May 26, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Obstruction of Flow1
Patient problems
- Thrombosis/Thrombus3
- Fever2
- Pain2
- Swelling/ Edema2
- Air Embolism1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 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 DIAGNOSED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22083386 ↗InjuryJul 9, 2024Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN, HAD SWELLING ALONG WITH FEVER, AND WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Fever; Pain; Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 19699107 ↗InjuryJul 9, 2024Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN, HAD SWELLING ALONG WITH FEVER, AND WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Fever; Pain; Thrombosis/Thrombus
MAUDE report 19699058 ↗InjuryMay 26, 2021Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT POST PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD OCCLUSION AND THE PATIENT DEVELOPED A BLOOD CLOT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EDEMA. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.
Patient problems: Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 11885343 ↗InjuryJan 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN AIR EMBOLISM SOME TIME POST PORT CATHETER IMPLANT. THE PATIENT STATUS IS UNKNOWN.
Patient problems: Air Embolism
MAUDE report 8210614 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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