BioFlo 44022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965440220), received between Sep 26, 2017 and Oct 21, 2024 — classified as 1 injury, 2 malfunctions.

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 18, 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 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS BIOFLO PRODUCT, MODEL #/MFG CAT ID: H965440220, LOT NUMBER 5482424. UPON INFORMATION AND BELIEF, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR CHEMOTHERAPY TREATMENT FOR PLAINTIFF'S GLIOBLASTOMA MULTIFORME. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), WITH A BLOCKED PORT-A CATH, WHICH PROMPTED EVALUATION OF HIS CATHETER. UPON INFORMATION AND BELIEF, ON (B)(6) 2021, THE PLAINTIFF'S MEDICAL TEAM DETERMINED THAT PLAINTIFF HAD A PORT-A-CATH INFECTION. THE PLAINTIFF MEDICAL TEAM THEN DECIDED TO ARRANGE FOR PLAINTIFF'S PORT REMOVAL THROUGH INTERVENTIONAL RADIOLOGY. ON (B)(6) 2021, (B)(6) PRESENTED TO THE OPERATING ROOM AT (B)(6) MEDICAL CENTER. UPON INFORMATION AND BELIEF, THE INFECTED PORT WAS THEN REMOVED BY DR. (B)(6), MD, AN INTERVENTIONAL RADIOLOGIST.

  Patient problems: Unspecified Infection

  MAUDE report 20493326 ↗
• MalfunctionJan 15, 2018Aspiration Issue; Aspiration Issue

  AS REPORTED, BIOFLO PORT PLACED ON (B)(6) 2017 WAS REMOVED ON (B)(6) 2017 BECAUSE OF FIBRIN SHEATH FORMATION NEAR THE TIP OF THE CATHETER CAUSING OCCLUSION. THERE WAS NO INJURY INCURRED BY THE PATIENT. THE USED DEVICE WILL NOT BE RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7191469 ↗
• MalfunctionSep 26, 2017Device Contamination with Chemical or Other Material; Infusion or Flow Problem; Device Contamination with Chemical or Other Material; Infusion or Flow Problem

  ON (B)(6) 2017 THE PATIENT HAD A BIOFLO PORT IMPLANTED. UPON COMPLETING SURGERY, THE MD WAS UNABLE TO ASPIRATE THE PORT. WITH THE PATIENT STILL ON THE TABLE, THE PHYSICIAN REMOVED THE PORT AND INSERTED A NEW PORT, USING SAME CATHETER. ABLE TO DRAW BLOOD AND INFUSE. A JELLY-LIKE SUBSTANCE WAS REPORTED TO BE FOUND IN THE PORT CHAMBER. THERE WAS NO IMPACT ON THE PATIENT. THE ORIGINAL PORT HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6893322 ↗