PowerPort, ChronoFlex 1708070Recalls & reported problems
Bard Access Systems, Inc. · PowerPort Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Microintroducer Kit (with Suture Plugs) · Class 2 · Implant
All models of PowerPort, ChronoFlex (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741026652), received between Nov 2, 2018 and Mar 18, 2026 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available1
- Contamination1
- Contamination /Decontamination Problem1
- Difficult to Insert1
- Expulsion1
- Failure to Infuse1
- Suction Problem1
Patient problems
- Unspecified Infection4
- Thrombosis/Thrombus3
- Sepsis2
- Erythema1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
- Pain1
- Skin Erosion1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION, THROMBOSIS AND SEVERE SEPSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Sepsis; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 24625073 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION, THROMBOSIS AND SEVERE SEPSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Sepsis; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 24624751 ↗InjurySep 10, 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 23013530 ↗InjuryNov 8, 2024Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Pain; Skin Erosion; Unspecified Infection
MAUDE report 20638077 ↗MalfunctionJan 21, 2021Difficult to Insert; Suction Problem; Failure to Infuse; Difficult to Insert; Suction Problem; Failure to Infuse
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1708070 IMPLANTED PORT ALLEGEDLY EXPERIENCED DIFFICULT TO INSERT, UNABLE TO INFUSE AND ASPIRATE ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 11211388 ↗MalfunctionNov 12, 2020Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem
IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE DEVICE PACKING ALLEGEDLY HAD A STRAND OF HAIR. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10827912 ↗InjuryNov 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PORT SITE ALLEGEDLY PRESENTED WITH PUS UNDER THE DRESSING WITH ODOR AND REDNESS. THERE PATIENT STATUS IS UNKNOWN.
Patient problems: Erythema; Unspecified Infection
MAUDE report 8035235 ↗
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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