PowerPort M.R.I. 1809601Recalls & reported problems
Bard Access Systems, Inc. · PowerPort M.R.I. Implantable Port with Attachable 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
- 20
- Deaths reported
- 2
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741027147), received between Jul 21, 2020 and Jul 3, 2026 — classified as 2 deaths, 14 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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 Problem14
- Fracture4
- Device Appears to Trigger Rejection2
- Migration2
- Obstruction of Flow2
- Component Missing1
- Material Protrusion/Extrusion1
- Material Separation1
Patient problems
- Unspecified Infection11
- Thrombosis/Thrombus5
- No Clinical Signs, Symptoms or Conditions3
- Pulmonary Embolism2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Cellulitis1
- Erythema1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2026Device Appears to Trigger Rejection; Obstruction of Flow; Material Protrusion/Extrusion; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER AND PORT BODY AND RESERVOIR ALLEGEDLY BECAME OCCLUDED. ADDITIONALLY, PROTRUSION AND MIGRATION WERE OBSERVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 25700990 ↗DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 24710699 ↗InjuryMar 11, 2026Device Appears to Trigger Rejection; Adverse 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 AND PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 24566146 ↗InjuryMar 9, 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 24544351 ↗MalfunctionFeb 19, 2026Fracture
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY HAD FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24386551 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, TWENTY-ONE DAYS, AFTER THE PORT PLACEMENT VIA INTERNAL JUGULAR VEIN FOR THE NEED OF LONG-TERM IV THERAPY AND BLOOD TRANSFUSIONS, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24036404 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR, TWO MONTHS AND TWENTY-SEVEN DAYS OF PORT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN FOR THE NEED OF LONG-TERM IV THERAPY AND BLOOD TRANSFUSIONS, THE PATIENT WAS DIAGNOSED WITH AN INFECTED PORT. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24036204 ↗InjuryNov 25, 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 AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23643546 ↗InjuryNov 20, 2025Fracture; Obstruction of Flow; Fracture; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY HAD FRACTURED. PATIENT WAS DIAGNOSED WITH THROMBOSIS AND OCCLUSION OF THE THROMBUS. THE CURRENT STATUS OF PATIENT WAS UNKNOWN.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 23602159 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23540274 ↗DeathOct 6, 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 AN UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23219120 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, ON (B)(6), 2021, A PATIENT UNDERWENT RIGHT SIDED PORT PLACEMENT, USING A BARD POWERPORT MRI IMPLANTABLE PORT CATHETER, FOR LONG TERM INTRAVENOUS THERAPY AND BLOOD TRANSFUSIONS. APPROXIMATELY ONE YEAR, FIVE MONTHS AND FIVE DAYS LATER, ON (B)(6), 2023, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6), 2023. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22861749 ↗MalfunctionApr 5, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PORT PLACEMENT, WHEN CONNECT THE CATHETER TO THE PORT THE SILICONE CATHETER ALLEGEDLY BROKEN AT THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21781100 ↗InjuryMar 17, 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 21615730 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 20608374 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH AND TWENTY DAYS POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH ERYTHEMA. IT WAS FURTHER REPORTED THAT PATIENT WAS DIAGNOSED WITH BACTERIAL INFECTION AND CELLULITIS. REPORTEDLY, THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacterial Infection; Cellulitis; Erythema; Unspecified Infection
MAUDE report 19761334 ↗InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO WEEKS AND SIX DAYS POST A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS AND MASSIVE PULMONARY EMBOLISM. REPORTEDLY, PATIENT UNDERWENT EXTENSIVE SURGERY TO REMOVE THE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 18189245 ↗InjuryOct 21, 2023Fracture; Material Separation; Migration; Fracture; Material Separation; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE YEAR TWO MONTHS FROM PORT PLACEMENT PROCEDURE FOR CHEMOTHERAPY TREATMENT, THE PORT WAS ALLEGEDLY NO LONGER FUNCTIONED. IT WAS FURTHER REPORTED THE CATHETER FRAGMENT WAS DIAGNOSED IN PATIENTS HEART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17982134 ↗MalfunctionMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD PAINS AND SPASMS IN HER NECK THAT RADIATE UP INTO HER JAW AND TONGUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16495788 ↗MalfunctionJul 21, 2020Component Missing; Component Missing
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1809601 IMPLANTABLE PORT ALLEGEDLY WAS MISSING CATHETER. THIS INFORMATION WAS RECEIVED FROM (B)(6). OF THE ONE MALFUNCTION, THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCES. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10303363 ↗
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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