BioFlo Vortex H787CT80LPPDNFVI0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15051684017206), received between Sep 18, 2025 and Aug 9, 2026 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2026Adverse Event Without Identified Device or Use Problem

  An End User reported an issue with a SMARTPORT 8F SL PLASTIC NON-FILLED DET PU VI. A patient underwent internal jugular insertion of the port and received her first of four, chemotherapy treatments on (b)(6) 2026; consisting of Docetaxel and Cyclophosphamide. Palonosetron and Pegfilgrastim were also delivered as supporting agents. Following the first chemotherapy treatment, the patient developed significant skin reactions and port site inflammation, leading to port removal on (b)(6) 2026, due to a suspected allergy. After port removal, the rash resolved and the patient tolerated the second cycle and G-CSF injection without complications. Despite multiple good faith efforts, no further details have been obtained.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50189039 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF THE DEFECTIVE DEVICE. THE DEFECTIVE DEVICE WAS IMPLANTED AT (B)(6) FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF NAUSEA AND VOMITING. BLOOD CULTURES RETURNED POSITIVE FOR MRSA, CONFIRMING SEPSIS. REMOVAL OF THE DEFECTIVE DEVICE WAS RECOMMENDED. ON OR ABOUT (B)(6) 2024. PLAINTIFF'S DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), MD AT (B)(6).

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 23828457 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) TO UNDERGO RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, WITH MODEL NUMBER: CT80LPPDNFVI, AND LOT NUMBER: 5654008. ON (B)(6) 2021, IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT ON (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6). UPON EVALUATION, PLAINTIFF'S MEDICAL TEAM DETERMINED THAT HIS SMARTPORT ERODED THROUGH HIS SKIN, REQUIRING REMOVAL OF THE SMARTPORT. ON OR ABOUT ON (B)(6) 2022, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE SMARTPORT. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6). M.D.

  Patient problems: Skin Erosion

  MAUDE report 23085418 ↗