BioFlo 44014Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI H965440140), received between Jun 22, 2016 and Dec 13, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS BIOFLO, REFERENCE NUMBER: (B)(4), LOT NUMBER: 5669956. THE DEVICE WAS IMPLANTED BY (B)(6) M.D., AT (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY FOR HER BREAST CANCER. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20926228 ↗
• InjuryJan 5, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  APPROXIMATELY 5 MONTHS AFTER IMPLANTATION OF A BIOFLO PORT, THE PATIENT UNDERWENT CATHETER INJECTION UNDER FLUOROSCOPIC GUIDANCE. ON (B)(6) 2019, THE PATIENT PRESENTED FOR PLACEMENT OF A BIOFLO PORT FOR THE ADMINISTRATION OF MEDICATION OF CHRON'S DISEASE. ON (B)(6) 2019, THE PATIENT UNDERWENT A CATHETER INJECTION UNDER FLOUROSCOPIC GUIDANCE. AT THIS TIME, THE PATIENT EXPERIENCED SEVERE PAIN AND THE INJECTION WAS TERMINATED. FLUOROSCOPIC FINDINGS DEMONSTRATED "CONFINED EXTRAVASATION AT THE MIDPORTION OF THE CATHETER, LIKELY INTO THE SUBCUTANEOUS TISSUES FROM CATHETER DEFECT." ON (B)(6) 2020 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE DEFECTIVE DEVICE AND REPLACE IT WITH ANOTHER SAME DEVICE. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Pain

  MAUDE report 11117504 ↗
• InjuryJan 5, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2018, THE PATIENT PRESENTED FOR SUBCLAVIAN PLACEMENT OF A BIOFLO PORT PORT FOR ADMINISTRATION OF CHEMOTHERAPY FOR BREAST CANCER. FOLLOWING THE IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT ON THE UPPER RIGHT ANTERIOR CHEST, NECK,AND AXILLAE. ON (B)(6) 2018, THE PORT SITE WAS ASSESSED AND SEROSANGUINOUS FLUID WAS FOUND MEDIAL TO THE PORT RESERVOIR, WITH NO SIGNS OF INFECTION. THE FOLLOWING MONTH ((B)(6) 2018), THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE DEFECTIVE DEVICE. UPON INCISION OF THE PORT SITE, CLOUDY SEROSANGUINEOUS FLUID IMMEDIATELY WELL UP AND POURED THROUGH THE OPEN INCISION. ALLEGEDLY DUE TO LEAKAGE OF THE CHEMOTHERAPY MEDICATION, THE POCKET WAS NOTED TO CONTAIN "ADHERENT BLACK AND BROWN SOFT TISSUE DEBRIS, SOME OF WHICH APPEARED TO REPRESENT OLD BLOOD CLOT AND NECROTIC TISSUE." THE SURGEON DEBRIDED THE NECROTIC TISSUE UNTIL THE POCKED APPEARED WELL-VASCULARIZED AND VIABLE. A WEEK LATER ((B)(6) 2018), A NEW BIOFLO PICC WITH 4FR SINGLE LUMEN CATHETER, WAS PLACED. THE FOLLOWING WEEK AFTER PLACEMENT ((B)(6) 2018), THE PATIENT PRESENTED TO THE HOSPITAL WITH OCCLUSIVE DEEP VENOUS THROMBOSIS, WITHIN THE LEFT UPPER EXTREMITY AND ACUTE PULMONARY EMBOLIS

  Patient problems: Bacterial Infection; Chest Pain; Decreased Respiratory Rate; Device Embedded In Tissue or Plaque; Erosion; Fluid Discharge; Infiltration into Tissue; No Code Available; No Information; No Known Impact Or Consequence To Patient; Pain; Perforation; Pneumothorax; Post Operative Wound Infection; Skin Erosion; Tissue Breakdown; Unspecified Infection

  MAUDE report 11116792 ↗
• MalfunctionJul 15, 2020Fracture; Fracture

  AN END USER REPORTED AN ISSUE WHEN PLACING THIS BIOFLO PORT. THE PHYSICIAN EXPERIENCED DIFFICULTIES WHEN REMOVING THE CATHETER FROM THE METAL TUNNELER. AFTER PULLING AND DISENGAGING THE CATHETER FROM THE TUNNELER, THE CATHETER STRETCHED AND THEN SPLIT. A NEW KIT WAS NEEDED TO REPLACE THE PORT, FROM START TO FINISH. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED FROM THE END USER; HOWEVER, THE PROCEDURE WAS PROLONGED FOR GREATER THAN 30 MINUTES. THIS EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT AS THE PATIENT WAS SEDATED GREATER THAN 30 MINUTES LONGER THAN AS EXPECTED FOR THIS TYPE OF PROCEDURE. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Consequences Or Impact To Patient; Sedation

  MAUDE report 10278050 ↗
• InjuryMay 12, 2020Migration; Migration

  AN ANGIODYNAMICS VASCULAR CONSULTANT REPORTED THAT PART OF A 8F BIOFLO PLASTIC PORT'S STEM ERODED THROUGH THE SKIN OF A PATIENT. THE PATIENT WAS RECEIVING INTERMITTENT CHEMOTHERAPY THAT WOULD INFUSE OVER THE COURSE OF 2-3 DAYS CONTINUOUSLY. PATIENT DESCRIBED THE PORT AREA AS MOIST ALONG THE ENTIRE BASE WHEN RECEIVING INFUSIONS. IT IS BELIEVED THE PORT MAY HAVE A SMALL LEAK. IT WAS REPORTED THE PATIENT EXHIBITED NO SIGNS OF OVERT INFECTION. A SMALL AREA OF CLEAN SKIN BREAKDOWN AT THE LATERAL CORNER OF THE INCISION WAS NOST LIKELY DUE TO PRESSURE/SKIN THINNING. PORT WAS REMOVED AND REPLACED IN THE OPPOSITE SIDE OF THE CHEST. THE PATIENT WAS REPORTED AS STABLE. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Infiltration into Tissue

  MAUDE report 10048579 ↗
• InjuryApr 25, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED, A BIOFLO PORT WHICH HAD BEEN PLACED IN (B)(6) 2016 WAS REMOVED ON (B)(6) 2019 BECAUSE "A CRACK IN THE PORT BODY WAS CAUSING EXTRAVASATION OF INFUSATES INTO THE PORT POCKET." IT WAS INDICATED THAT THE USED PORT WOULD BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Extravasation

  MAUDE report 8548958 ↗
• MalfunctionJun 22, 2016Occlusion Within Device; Occlusion Within Device

  PATIENT HAD A BIOFLO PORT PLACED LESS THAN A YEAR AGO. HE RESPONDED WELL TO HIS CHEMO, HAD COMPLETED HIS THERAPY, AND WAS CURRENTLY JUST MAINTAINING THE PORT. THE INFUSION NURSES WERE NOT ABLE TO FLUSH IT (OCCLUDED WITH AN OBVIOUS CLOT), SO THEY DECIDED TO SEND HIM BACK TO DR. (B)(6) FOR THE REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5742130 ↗