BioFlo Vortex H787CT80LTBDVI0Recalls & reported problems
Angiodynamics, Inc. · SmartPort+ Low Profile Port with Endexo and Vortex Technology · Class 2 · Implant
All models of BioFlo Vortex (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684017046), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 injury.
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 Problem1
Patient problems
- Bacteremia1
- Endocarditis1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT ON (B)(6) 2023, (B)(6) UNDERWENT AN INSERTION AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER: H787CT80LTBDVI0, LOT NUMBER: LOG718309. UPON INFORMATION AND BELIEF, THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6) FOR MEDICATION AND IMMUNOTHERAPY TREATMENT. (B)(6) AND HIS HEALTH CARE PROVIDERS USED THE SMARTPORT IN A NORMAL, CUSTOMARY, INTENDED, AND FORESEEABLE MANNER, NAMELY AS A SURGICALLY PLACED DEVICE USED TO MAKE IT EASIER TO DELIVER MEDICATIONS DIRECTLY INTO THE DECEDENT'S BLOODSTREAM. MOREOVER, DECEDENT'S HEALTH CARE PROVIDERS DID NOT PLACE OR MAINTAIN THE DEVICE INCORRECTLY SUCH THAT IT CAUSED THE DEVICE TO "PINCH OFF" OR OTHERWISE MALFUNCTION. ON OR ABOUT ON (B)(6) 2023, (B)(6) PRESENTED TO (B)(6) HOSPITAL IN (B)(6) WITH COMPLAINTS OF FEVERS AND CHILLS. HE REMAINED IN THE HOSPITAL UNTIL ON (B)(6) 2023. DURING THIS HOSPITAL STAY, (B)(6) WAS DIAGNOSED WITH AN ENTEROCOCCUS FAECALIS BACTERMIA INFECTION WITH ENDOCARDITIS AND SEPSIS, WHICH HIS DOCTORS TOLD HIM WAS CAUSED BY HIS SMARTPORT. WHILE (B)(6) DOCTORS ELECTED NOT TO REMOVE HIS SMARTPORT AT THAT TIME DUE TO CERTAI
Patient problems: Bacteremia; Endocarditis; Sepsis
MAUDE report 23850078 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page