BioFlo H965440250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15051684018760), received between Dec 5, 2025 and Jun 5, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6), 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS BIOFLO PORT CATHETER PRODUCT, WITH MODEL NUMBER 44-025, AND LOT NUMBER 5791651. THE BIOFLO PORT DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL - (B)(6), PENNSYLVANIA, FOR THE PRINCIPAL PURPOSE OF ADMINISTRATION OF CHEMOTHERAPY TREATMENT OF PLAINTIFF'S OVARIAN CANCER. ON OR ABOUT (B)(6), 2024, PLAINTIFF PRESENTED TO(B)(6) HOSPITAL - MONROE CAMPUS IN (B)(6), PENNSYLVANIA, COMPLAINING OF PURULENCE, ERYTHEMA AND PAIN AT HER PORT SITE. PLAINTIFF'S BIOFLO PORT CATHETER WAS SUSPECTED TO BE INFECTED ORDERED TO BE REMOVED. (B)(6) HOSPITAL - MONROE CAMPUS IN(B)(6), PENNSYLVANIA. PLAINTIFF WAS HOSPITALIZED FOR ABOUT A WEEK, DURING WHICH TIME PLAINTIFF'S BLOOD CULTURES GREW METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS ("MSSA"), AND CULTURES FROM PLAINTIFF'S BIOFLO PORT CATHETER TIP GREW MSSA AND EIKENELLA CORRODENS.

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection; Erythema; Implant Pain; Purulent Discharge

  MAUDE report 25415304 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS BIOFLO PORT IN HIS RIGHT CHEST WALL, REFERENCE NUMBER (B)(4), LOT NUMBER 5817581. THE DEVICE WAS IMPLANTED BY (B)(6), MD AT (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS FOR CHEMOTHERAPY TO TREAT PLAINTIFF'S PANCREATIC CANCER. ON OR ABOUT (B)(6) 2024, THE PLAINTIFF PRESENTED TO THE EMERGENCY DEPARTMENT AT (B)(6) COMPLAINING OF RIGHT-SIDED NECK PAIN WITH ASSOCIATED FACIAL REDNESS AND SWELLING, WHICH HE HAD BEEN EXPERIENCING FOR SEVERAL WEEKS, AS WELL AS BILATERAL HAND SWELLING. A CONTRAST ENHANCED CT-SCAN OF THE CHEST WAS PERFORMED WHICH REVEALED NEAR-COMPLETE SUPERIOR VENA CAVA (SVC) THROMBUS EXTENDING FROM THE RIGHT CHEST WALL PORT THROUGH THE RIGHT INTERNAL JUGULAR VEIN INTO THE SUPERIOR VENA CAVA. THERE WERE MILD BILATERAL CHEST WALL VARICES LACKING ASYMMETRY SUGGESTING AN ACUTE OCCLUSION. THE EXAM ALSO FOUND NEW SUPRACLAVICULAR LYMPHADENOPATHY PRESENT, NOTING IT WAS POSSIBLY DUE TO METASTASIS OR REACTIVE CHANGES FROM THROMBOSIS/INFLAMMATION. PLAINTIFF WAS PRESCRIBED LONG-TERM ANTICOAGULANT MEDICATION TO TREAT HIS SVC THROMBUS. ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT A PORT REMOVAL AND SUPERIOR VENA

  Patient problems: Neck Pain; Skin Discoloration; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 23728186 ↗