PowerPort 1759601Recalls & reported problems
Bard Access Systems, Inc. · PowerPort 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 (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741026867), received between Apr 26, 2023 and Nov 29, 2024 — classified as 1 death, 3 injuries.
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. 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
- Fracture3
- Material Separation3
- Migration3
- Difficult to Remove2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2024Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT ALLEGEDLY DEVELOPED WITH CATHETER FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 20810674 ↗InjuryNov 27, 2024Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, NINE MONTHS AND SEVEN DAYS LATER PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED AND THE CATHETER FRAGMENT MIGRATED TO LUNG. THE CATHETER FRAGMENT WAS UNABLE TO BE RETRIEVED BECAUSE IT HAD TRAVELLED TO PATIENT'S PULMONARY ARTERY. THE PATIENT WAS THEN TRANSFERRED TO INTERVENTIONAL RADIOLOGY, WHERE MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE CATHETER FRAGMENT THROUGH GROIN. ONE DAY LATER, ADDITIONAL PROCEDURES WERE CARRIED AND THE CATHETER FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S PULMONARY ARTERY VIA GROIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20794668 ↗InjurySep 17, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY HAD FRACTURED. IT WAS FURTHER REPORTED THAT THE FRACTURED CATHETER MIGRATED INTO THE RIGHT VENTRICLE. REPORTEDLY, THE PORT WAS REMOVED AND FRACTURED CATHETER REMAINS IN PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient
MAUDE report 20234833 ↗DeathApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPIRED WHILE USING A PORT DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENTS CAUSE OF DEATH IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 16813388 ↗
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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