PowerPort M.R.I., ChronoFlex 1808050Recalls & reported problems
Bard Access Systems, Inc. · PowerPort isp M.R.I. Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Microintroducer Kit (With Suture Plugs) · Class 2 · Implant
All models of PowerPort M.R.I., ChronoFlex (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPort MRI implanted port has 39 adverse event reports, with no deaths, 30 injuries, and 9 malfunctions. Reports mostly describe thrombosis and unspecified infections after port placement, along with flow obstruction or device breakage. No recalls name this device. Reports dropped from 14 in the prior 12 months to 6 in the most recent 12 months.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741027000), received between Jun 18, 2018 and Sep 24, 2026 — classified as 31 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (6 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
- Obstruction of Flow6
- Device Appears to Trigger Rejection4
- Defective Component2
- Fluid/Blood Leak2
- Fracture2
- Suction Problem2
- Air/Gas in Device1
Patient problems
- Thrombosis/Thrombus14
- Unspecified Infection13
- Pain5
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient3
- Obstruction/Occlusion3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Device Appears to Trigger Rejection
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 was unknown.
Patient problems: Thrombosis/Thrombus
MAUDE report 50880023 ↗InjuryJul 3, 2026Device Appears to Trigger Rejection; Obstruction of Flow
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION, THROMBOSIS AND OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 25701597 ↗InjuryJun 26, 2026Device Appears to Trigger Rejection
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 25632898 ↗InjuryJun 12, 2026Device Appears to Trigger Rejection; Obstruction 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 25484690 ↗InjuryFeb 26, 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 24451306 ↗InjuryDec 13, 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 WAS DIAGNOSED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23797175 ↗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 23484096 ↗InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ELEVEN MONTHS AND ONE DAY LATER PORT PLACEMENT PROCEDURE VIA THE RIGHT SUBCLAVIAN VEIN FOR LONG TERM TOTAL PARENTERAL NUTRITION, THE PATIENT DIAGNOSED WITH AN OCCLUDED RIGHT INTERNAL JUGULAR VEIN AND CHRONIC THROMBUS. IT WAS FURTHER REPORTED THAT THE OCCLUDED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 23378980 ↗InjuryOct 24, 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus; Unspecified Infection
MAUDE report 23378978 ↗InjurySep 12, 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 23035122 ↗InjurySep 12, 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 AND CHEST PAIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Chest Pain; Unspecified Infection
MAUDE report 23034917 ↗InjurySep 4, 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 22961843 ↗InjuryAug 19, 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 22837719 ↗InjuryJul 30, 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 22662223 ↗InjuryJul 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 PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 22607493 ↗InjuryMay 27, 2025Restricted Flow rate; Blocked Connection; Restricted Flow rate; Blocked Connection
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD POOR FLOW AND DIFFICULTY ACCESSING AND REQUIRED TPA FREQUENTLY. FURTHERMORE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 22085817 ↗InjuryApr 7, 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 , PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Embolism/Embolus; Thrombosis/Thrombus
MAUDE report 21783434 ↗InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION AND WOUND COMPLICATIONS AT THE PORT-BODY SITE. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 21512277 ↗InjuryFeb 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 PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 21330742 ↗InjuryFeb 7, 2025Disconnection; Migration; Disconnection; Migration
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER MIGRATED/DISLODGEMENT. PATIENT HAD DEVELOPED WITH THROMBOSIS AND PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Pulmonary Embolism; Thrombosis/Thrombus
MAUDE report 21330622 ↗InjuryJan 11, 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 LATER POST A PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Sepsis
MAUDE report 21132723 ↗InjuryOct 28, 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 20542960 ↗InjurySep 22, 2024Adverse 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 THROMBOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED VASCULAR INJURY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Thrombosis/Thrombus
MAUDE report 20275857 ↗InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT NINE YEARS, ONE MONTH AND TWENTY-ONE DAYS POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED THROMBOSIS OF THE RIGHT JUGULAR VEIN. REPORTEDLY, THE PATIENT WAS PROVIDED WITH ANTICOAGULANT, AND THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 19525508 ↗InjuryMar 19, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED BURNING AND ITCHING AT THE PORT LOCATION. REPORTEDLY, PATIENT WAS PRESCRIBED WITH ANTIHISTAMINES AND CORTICOSTEROID MEDICINES FOR TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Itching Sensation
MAUDE report 18929006 ↗
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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