BioFlo H965440140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15051684018685), received between Aug 7, 2025 and Nov 17, 2025 — classified as 1 injury, 1 malfunction.

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.

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.

• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS BIOFLO POWER INJECTABLE PORT, MODEL/CAT NUMBER H965440140, LOT NUMBER 5081454. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO PORT SITE INFECTION LEADING TO BACTEREMIA.

  Patient problems: Bacteremia; Medical device site infection

  MAUDE report 23576849 ↗
• MalfunctionAug 7, 2025Fracture

  ON [DATE REDACTED] -- APPROXIMATELY 7 DAYS AGO, A CHEST X-RAY REVEALED THE LEFT PORT CATHETER IS FRACTURED. PATIENT WENT TO IR [INTERVENTIONAL RADIOLOGY] WHO REPORTED SUCCESSFUL REMOVAL OF THE FRACTURED LEFT SUBCLAVIAN PORT CATHETER AND REMOVAL OF THE RETAINED PORT CATHETER FRAGMENT FROM THE RIGHT ATRIUM/HEPATIC VEIN CONFLUENCE. PATIENT'S LAST CHEMO WAS IN [REDACTED] -- APPROXIMATELY 6 MONTHS AGO.

  Patient problems: Foreign Body In Patient

  MAUDE report 22737168 ↗