BioFlo Vortex H787CT60LPBDNFVI0Recalls & reported problems
Angiodynamics, Inc. · SmartPort+ Low Profile 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 15051684017121), received between Apr 10, 2026 and Apr 10, 2026 — 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
- Bacterial Infection1
- Chills1
- Fever1
- Low Blood Pressure/ Hypotension1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
ON OR ABOUT (B)(6) 2022, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, CT60LPBDNFVI. THE DEVICE WAS IMPLANTED BY DR. (B)(6), DO TO BE USED FOR CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED HERSELF TO (B)(6) WITH A CHIEF COMPLAINT OF FEVER, HYPOTENSION, AND CHILLS, WHERE SHE WAS DIAGNOSED WITH SEPSIS RELATED TO PORT INFECTION.
Patient problems: Bacterial Infection; Chills; Fever; Low Blood Pressure/ Hypotension; Sepsis
MAUDE report 24841557 ↗
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- 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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