PowerPort M.R.I., ChronoFlex 1808069Recalls & reported problems
Bard Access Systems, Inc. · PowerPort isp M.R.I. Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Intermediate 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 implantable port, used with a ChronoFlex catheter, sits under the skin to deliver medicines and draw blood. The 43 reports mostly describe infections at the port site or in the bloodstream, along with blood clots forming in the catheter, skin breakdown over the port, and ports that were expelled or hard to flush. Five reports describe a death and 31 an injury; in the death reports the cause was not given. No recalls name this device.
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
- 41
- Deaths reported
- 4
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741027062), received between Apr 17, 2019 and Sep 25, 2026 — classified as 4 deaths, 30 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Expulsion” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem28
- Expulsion3
- Obstruction of Flow3
- Device Appears to Trigger Rejection2
- Difficult to Flush2
- Fracture2
- Migration2
- Suction Problem2
Patient problems
- Unspecified Infection26
- No Consequences Or Impact To Patient5
- Skin Erosion3
- Thrombosis/Thrombus3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Sepsis2
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fracture; Material Separation; Migration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50896667 ↗InjuryMay 28, 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 25312349 ↗InjuryMar 26, 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 AND OCCLUSION. ADDITIONALLY, FIBRIN SHEATH FORMATION WAS OBSERVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Obstruction/Occlusion; Unspecified Infection
MAUDE report 24698665 ↗DeathFeb 12, 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 24320962 ↗InjuryJan 19, 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 IS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24107033 ↗DeathDec 30, 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, 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 23919800 ↗InjuryDec 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, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23891716 ↗InjuryDec 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 AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23886700 ↗InjuryNov 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 POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 23654063 ↗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 23473954 ↗InjuryOct 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 23423564 ↗InjuryOct 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 23423258 ↗MalfunctionOct 23, 2025Obstruction of Flow; Migration; Obstruction of Flow; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, CATH LUMEN OCCLUSION AND MIGRATION WERE OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364999 ↗InjuryOct 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23321016 ↗InjuryOct 16, 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 23312380 ↗DeathSep 10, 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 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 23012632 ↗InjurySep 3, 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 22951029 ↗InjuryAug 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 PAIN AT PORT SITE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Pain
MAUDE report 22780337 ↗InjuryJul 29, 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 SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Sepsis
MAUDE report 22640623 ↗InjuryJun 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 22335241 ↗InjuryJun 26, 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 DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22334221 ↗InjuryJun 16, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22209568 ↗InjuryMay 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 AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22001284 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2017, PATIENT UNDERWENT BARD POWERPORT ISP M.R.I. IMPLANTABLE PORT PLACEMENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION. ABOUT SOMETIME AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 21983750 ↗DeathMar 17, 2025Expulsion; Expulsion
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2012, A PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN FOR THE TREATMENT OF CHRONIC LYMPHOID LEUKEMIA. APPROXIMATELY TWO MONTHS AND FOUR DAYS LATER, ON (B)(6) 2012, THE PATIENT EXPERIENCED EROSION AT THE PORT BODY SITE. SUBSEQUENTLY, THE PORT WAS REMOVED ON (B)(6) 2012. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.
Patient problems: Insufficient Information; Skin Erosion
MAUDE report 21616924 ↗
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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