PowerPort, ChronoFlex 1706061Recalls & reported problems
Bard Access Systems, Inc. · PowerPort isp Implantable Port with Attachable 6F ChronoFlex Open-Ended Single-Lumen Venous Catheter. Intermediate Kit (without Suture Plug) · Class 2 · Implant
All models of PowerPort, ChronoFlex (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 2
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741026553), received between Aug 29, 2019 and Sep 28, 2026 — classified as 2 deaths, 7 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Device Appears to Trigger Rejection1
- Difficult to Flush1
- Expulsion1
- Fracture1
- Obstruction of Flow1
Patient problems
- Unspecified Infection4
- Thrombosis/Thrombus3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Sepsis2
- Skin Erosion2
- Bacterial Infection1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Expulsion
It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection, erosion and wound complications. However, the current status of the patient was unknown.
Patient problems: Skin Erosion; Unspecified Infection
MAUDE report 50911165 ↗InjuryMar 23, 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 REMAINS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 24659470 ↗MalfunctionNov 7, 2025Fracture; Fracture
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494409 ↗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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 22781528 ↗InjuryAug 11, 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 22768891 ↗InjuryJun 10, 2024Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THREE MONTHS AND FOUR DAYS POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY MIGRATED THE PATIENT REPORTEDLY DIAGNOSED WITH FIBRIN SHEATH FORMATION AROUND THE TIP OF THE PORT CATHETER. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS, INFECTION AND SEPSIS. REPORTEDLY, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Sepsis; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 19496744 ↗DeathMay 23, 2024Difficult to Flush; Suction Problem; Migration; Difficult to Flush; Suction Problem; Migration
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT FOUR DAYS POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY NON-FUNCTIONAL. IT WAS FURTHER REPORTED THAT THE PORT HAD ALLEGEDLY MIGRATED. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. EVIDENTLY, THE PATIENT WAS EXPIRED, AND PRIMARY CAUSE OF DEATH WAS NOT PROVIDED, AND THE RELATIONSHIP OF DEATH WITH THE DEVICE WAS NOT PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 19379049 ↗DeathApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO MONTHS AND NINE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH CLOSTRIDIUM DIFFICILE INFECTION RELATED TO THE PORT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH SEVERE SEPSIS AND EXPERIENCED SEPTIC SHOCK. REPORTEDLY, THE INFECTED PORT WAS REMOVED. EVIDENTLY, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Sepsis; Septic Shock; Unspecified Infection
MAUDE report 19030604 ↗InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT ALLEGEDLY HAD PAIN IN THE RIGHT CHEST AND ARM. IT WAS FURTHER REPORTED THAT THE PATIENT HAD SWELLING AND DIFFICULTY SWALLOWING. THE PATIENT CURRENT STATUS WAS UNKNOWN.
Patient problems: Pain; Swelling/ Edema
MAUDE report 11145574 ↗MalfunctionApr 14, 2020Obstruction of Flow; Obstruction of Flow
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1706061 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED OBSTRUCTION OF FLOW. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) FEMALE. WEIGHT INFORMATION WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9960519 ↗InjuryAug 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT, THE PORT ALLEGEDLY ERODED THROUGH THE SKIN. REPORTEDLY, THE PATIENT IS SCHEDULED FOR PORT DEVICE REPLACEMENT. THE PATIENT'S STATUS IS REPORTED AS STABLE.
Patient problems: Skin Erosion
MAUDE report 8944445 ↗
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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