BioFlo Vortex H787CT80STBDNFVI0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684016919), received between Jun 11, 2026 and Jun 11, 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2022, PLAINTIFF WAS DIAGNOSED WITH AMYLOIDOSIS. THE TREATMENT FOR PLAINTIFF'S AMYLOIDOSIS INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HIS PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HIM. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "SMARTPORT", IDENTIFIED BY THE FOLLOWING: MODEL NUMBER: CT80STBDNFVI, LOT NUMBER: 5722766, MANUFACTURER: ANGIODYNAMICS, INC. 26 FOREST STREET, MARLBOROUGH, MA 01752, FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY AT (B)(6) HOSPITAL IN (B)(6). SUBSEQUENT TO THE PLACEMENT OF THE AFOREMENTIONED SMARTPORT, THE PLAINTIFF WAS CAUSED TO DEVELOP AN INFECTION, IDENTIFIED AS BACTEREMIA, WHICH UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. THE PLAINTIFF UNDERWENT MEDICAL TREATMENT FOR THE INFECTION. AS PART OF THIS MEDICAL TREATMENT FOR THE INFECTION, PLAINTIFF WAS ADMITTED TO (B)(6) MEDICAL CENTER ON OR ABOUT (B)(6) 2022, FOR TREATMENT OF BACTEREMIA WHICH, UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. AS FURTHER TREATMENT FOR THE INFECTIONS, ON OR ABOUT (B)(6) 2022, THE PORT CATHETER WAS REMOVED ENTIRELY AT (B)(6) MEDICA

  Patient problems: Bacteremia

  MAUDE report 25480891 ↗