BioFlo Vortex H787CT80LPBDNFVI0Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15051684017145), received between Mar 30, 2026 and May 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Malposition of Device1
Patient problems
- Chest Pain1
- Extravasation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Malposition of Device
A MANAGER OF INTERVENTIONAL RADIOLOGY OPS REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER NON-FILLED SH VALVED INTRODUCER. AFTER PORT PLACEMENT, A PATIENT EXPERIENCED LOSS OF ACCESS DUE TO THE PORT FLIPPING WITHIN THE POCKET FOLLOWING IMPLANTATION. THE PORT WAS SAID TO HAVE BEEN SUTURED AT TWO POINTS, WITHIN THE POCKET, USING 2-0 PDS DISSOLVABLE STITCHES. PATIENT WILL UNDERGO AN ADDITIONAL SURGICAL PROCEDURE DUE TO THE PORT FLIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25188853 ↗MalfunctionMar 30, 2026Fracture
ON OR ABOUT (B)(6), 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS 8F SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5743897. THE DEVICE WAS IMPLANTED BY DR. DAVID C. LYNN, MD AT (B)(6) HOSPITAL IN (B)(6) WISCONSIN, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY ADMINISTRATION. ON OR ABOUT (B)(6), 2023, PLAINTIFF WAS ADMITTED TO (B)(6) HOSPITAL FOR CHEST WALL PAIN. DURING HER EXTENDED HOSPITAL STAY, PLAINTIFF'S SMARTPORT WAS FOUND TO HAVE PORT LEAKAGE AND FIBRIN SHEATH OF THE PORT CATHETER THAT REQUIRED PORT REMOVAL AND REPLACEMENT. ON OR ABOUT (B)(6), 2023 FOLLOWING PLAINTIFF'S DIAGNOSIS, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED AT (B)(6) HOSPITAL BY DR. (B)(6) M.D. ON OR ABOUT (B)(6), 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS 8F SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5748718. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D. AT (B)(6) HOSPITAL WISCONSIN, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY ADMINISTRATION.
Patient problems: Chest Pain; Extravasation
MAUDE report 24728675 ↗
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- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
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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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