BioFlo Vortex H787CT60LPBDVI0Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684016698), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Fluid/Blood Leak; Material Puncture/Hole; Infusion or Flow Problem; Fluid/Blood Leak; Material Puncture/Hole; Infusion or Flow Problem
AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A 5F MINI TITANIUM VORTEX PORT ATTACHED BIOFLO CATHETER FILLED SH VALVED INTRODUCER. IT WAS REPORTED THAT A 5-MONTH-OLD FEMALE PATIENT HAD A PORT IMPLANTED ON (B)(6) 2025. PER A REPORT FROM THE PATIENT'S PRIMARY TEAM AND SURGEON THAT PLACED THE PORT, THE DEVICE WAS WORKING FINE INITIALLY; HOWEVER, AFTER A FEW DAYS IT STOPPED FLUSHING AND DRAWING. A CONTRAST STUDY WAS PERFORMED THAT SHOWED CONTRAST COPIOUSLY LEAKING OUT INTO THE SUBCUTANEOUS POCKET, WHERE THE PORT BODY WAS LOCATED. REPORTEDLY, IT WAS UNCLEAR AT THAT TIME IF THERE WAS JUST A BAD CONNECTION BETWEEN THE PORT BODY AND THE CATHETER, BUT ALL WERE CONFIDENT THAT IT HAD BEEN ACCESSED. ULTIMATELY, THE PATIENT WAS TAKEN TO THE OR TO DETERMINE WHAT WAS GOING ON AND A SMALL HOLE, IN THE CENTER OF THE BACK OF THE PORT BODY, WAS IDENTIFIED. THE PORT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963815 ↗
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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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