BioFlo Vortex H787CT50PTBDVI0Recalls & reported problems
Angiodynamics, Inc. · SmartPort+ Mini 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684016674), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Break; Entrapment of Device
PATIENT HAD A SMARTPORT SINGLE LUMEN MINI TITANIUM PORT REMOVED IN OR ON [REDACTED]. X-RAY OBTAINED THE NEXT DAY ON [REDACTED] SHOWING A METAL OBJECT IN THE CHEST AREA. BARREL THAT SECURES CATHETER TO THE PORT REMAINS IN THE PATIENT. ON FURTHER INSPECTION OF OTHER ANGIODYNAMICS SMARTPORT KITS, THERE IS ALSO CONCERN OF AN UNIDENTIFIED PIECE THAT IS FREE FLOATING IN THE KITS (ALL SAME LOT NUMBERS AS REMOVED PORT). SOMETIMES FOUND LOOSELY IN THE KIT AND ONE HAD THIS PIECE LODGED IN THE SYRINGE. IT COULD CREATE CONFUSION ON THE PURPOSE OF THIS PIECE AND WHETHER OR NOT IT IS SUPPOSED TO BE USED WITH THE DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 22318459 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
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- 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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