PowerPort, ChronoFlex 1706050Recalls & reported problems
Bard Access Systems, Inc. · PowerPort isp Implantable Port with Attachable 6F ChronoFlex Open-Ended Single-Lumen Venous Catheter. Microintroducer Kit (with 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741026515), received between Jul 1, 2021 and Aug 10, 2024 — classified as 4 injuries.
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 Problem4
Patient problems
- Pain2
- Bacteremia1
- Bacterial Infection1
- Sepsis1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY ELEVEN MONTHS AND SEVEN DAYS POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY DEVELOPED WITH BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED WITH BACTEREMIA AND SEPSIS AS A RESULT OF THE DEFECTIVE INFECTED PORT. REPORTEDLY, THE DEFECTIVE INFECTED PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacteremia; Bacterial Infection; Sepsis
MAUDE report 19957022 ↗InjuryAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 19956940 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED PAIN THAT GOES DOWN INTO CHEST AND INTO NIPPLE. THE PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: Pain
MAUDE report 12438579 ↗InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SIX YEARS POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY FELT PINS AND NEEDLES SENSATION THAT GOES UP INTO THE NECK AND EXPERIENCED HEADACHE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED ON LATER DAYS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: Pain
MAUDE report 12098139 ↗
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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