BioFlo 44025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965440250), received between Jul 19, 2017 and Oct 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Aspiration Issue” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS BIOFLO PRODUCT, MODEL/CAT NUMBER: H965440250, LOT NUMBER 5591591. UPON INFORMATION AND BELIEF, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), AT (B)(6) HOSPITAL - (B)(6), FOR CHEMOTHERAPY TREATMENT FOR PLAINTIFF'S TONSIL CANCER. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL- (B)(6), WITH A FEVER WHICH PROMPTED EVALUATION OF HIS CATHETER. THEN, (B)(6)'S MEDICAL TEAM DETERMINED THAT HIS PORT WAS INFECTED WITH 8 COLONIES OF COAGULASE-NEGATIVE STAPHYLOCOCCUS, WHICH RESULTED IN PLAINTIFF'S ACUTE KIDNEY INJURY, WHICH UPON INFORMATION AND BELIEF, WAS DIAGNOSED ON (B)(6) 2020, AND IT WAS ALSO DETERMINED THAT PLAINTIFF HAD AN OCCLUSIVE DEEP VENOUS THROMBOSIS WITHIN A PORTION OF THE RIGHT INTERNAL JUGULAR VEIN, WHICH, UPON INFORMATION AND BELIEF, WAS DIAGNOSED ON (B)(6) 2020. ON OR ABOUT (B)(6) 2020, (B)(6) WAS TRANSFERRED TO THE OPERATING ROOM AT (B)(6) HOSPITAL - (B)(6). UPON INFORMATION AND BELIEF, THE INFECTED PORT WAS THEN REMOVED BY HIS INTERVENTIONAL RADIOLOGIST. AS A RESULT OF HAVING THE BIOFLO IMPLANTED, (B)(6) HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITION

  Patient problems: Bacterial Infection; Fever; Thrombosis/Thrombus; Unspecified Kidney or Urinary Problem

  MAUDE report 20417779 ↗
• InjuryNov 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED, THE PHYSICIAN HAD PLACED THE PORT INTO THE PATIENT AND CLOSED THE POCKET. WHEN THE PORT WAS FLUSHED, THE CATHETER DETACHED AND MIGRATED TO THE RIGHT ATRIUM. THE CATHETER WAS SNARED AND REMOVED WITHOUT DIFFICULTY. THE PORT WAS THEN REPLACED, AT THAT TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060581 ↗
• InjuryJul 19, 2017Aspiration Issue; Aspiration Issue

  DETAILS OF THE PROBLEM AS PROVIDED BY THE PATIENT ARE THAT A BIOFLO PORT WAS IMPLANTED ON (B)(6) 2017 AFTER AN OPERATION FOR RECTAL CANCER. MULTIPLE NURSES / NEEDLE STICKS WERE NEEDED TO ACCESS THE PORT ON (B)(6) FOR AN IV. THE PHYSICIAN WAS FINALLY ABLE TO ACCESS. ON MARCH 29, 4 NURSES AGAIN WERE NEEDED BEFORE ACCESS WAS OBTAINED TO DRAW BLOOD FROM THE PORT. AFTER THE MULTIPLE ATTEMPTS ON (B)(6), "THE PORT AREA WAS SORE AND VERY SWOLLEN." THE PORT WAS REMOVED ON (B)(6) 2017 AND WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Swelling

  MAUDE report 6725652 ↗