BioFlo Vortex H787CT80LPBDVI0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15051684016773), received between Mar 10, 2025 and Sep 30, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 50953918 ↗
• MalfunctionApr 11, 2026Malposition of Device

  A RISK MANAGER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER FILLED SH VALVED INTRODUCER. THE PORT WAS IMPLANTED WITH 2-0 ABSORBABLE STITCHES; HOWEVER, WHEN THE PATIENT PRESENTED FOR AN INFUSION, THE PORT WAS FOUND TO HAVE FLIPPED AND ACCESS WAS UNABLE TO BE OBTAINED. THE PATIENT RECEIVED THEIR CHEMOTHERAPY TREATMENT PERIPHERALLY AND WAS THEN TRANSFERRED TO INTERVENTIONAL RADIOLOGY TO UNDERGO A PORT REVISION. ULTIMATELY, THE PATIENT WAS SEDATED SO AN INCISION COULD BE MADE TO FLIP AND SUTURE THE PORT BACK INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849206 ↗
• MalfunctionMar 10, 2026Malposition of Device

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XECLA NON-VALVED INJECTABLE PORT CATHETER DEVICE, WITH MODEL NUMBER CT80LPBONFV, AND LOT NUMBER 5734480. THE DEVICE WAS IMPLANTED BY DR. (B)(6), (B)(6) MEDICAL CENTER IN (B)(6), FOR CHEMOTHERAPY ADMINISTRATION TO TREAT PLAINTIFF'S BREAST CANCER. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO THE (B)(6) MEDICAL CENTER, (B)(6), FOR A NONFUNCTIONING PORT CATHETER. THE PROVIDERS NOTE THAT THE CATHETER HAD RETRACTED AND CURLED AROUND WITHIN THE RIGHT CHEST. ON OR ABOUT (B)(6), THE PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER, (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565603 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF (B)(6) UNDERWENT AN INSERTION AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT80LPBDVI, LOT NUMBER 5804580. UPON INFORMATION AND BELIEF, THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED AT (B)(6) FOR CHEMOTHERAPY TREATMENT. PLAINTIFF AND HIS HEALTH CARE PROVIDERS USED THE SMARTPORT IN A NORMAL, CUSTOMARY, INTENDED, AND FORESEEABLE MANNER, NAMELY AS A SURGICALLY PLACED DEVICE USED TO MAKE IT EASIER TO DELIVER MEDICATIONS DIRECTLY INTO THE PLAINTIFF'S BLOODSTREAM. MOREOVER, PLAINTIFF'S HEALTH CARE PROVIDERS DID NOT PLACE OR MAINTAIN THE DEVICE INCORRECTLY SUCH THAT IT CAUSED THE DEVICE TO "PINCH OFF" OR OTHERWISE MALFUNCTION. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) FOR TREATMENT OF A STAPH BACTEREMIA INFECTION CAUSED BY HIS SMARTPORT DEVICE, THAT WAS CONFIRMED AND DIAGNOSED VIA POSITIVE BLOOD CULTURES, RESULTING IN THE REMOVAL OF THE SMARTPORT DEVICE ON OR ABOUT (B)(6) 2023. THESE INJURIES WERE DIRECTLY AND PROXIMATELY CAUSED BY THE WRONGFUL CONDUCT OF THE DEFENDANTS AND THE UNREASONABLY DANGEROUS AND DEFECTIVE NATURE OF HIS SMARTPORT, AS FURTHER ALLEGED HEREIN.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 23618148 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Obstruction of Flow

  ON OR ABOUT ON (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: CT80LPBDV1; LOT NUMBER: 5777878. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. IN AND AROUND ON (B)(6) 2023, PLAINTIFF WAS HAVING PROBLEMS WITH HER PORTACATH. ON (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO THE (B)(6), WITH COMPLAINTS THAT THE SMARTPORT WAS NOT WORKING. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF WAS ADMITTED FOR SURGERY FOR PORT MANIPULATION AND POSSIBLE PORT EXCHANGE. SURGERY WAS PERFORMED AT THE (B)(6), BY DR. (B)(6). ANESTHESIA WAS MONITORED AT ALL TIMES DURING THE SURGERY. THE PREVIOUS INCISION OVER THE RIGHT CHEST AREA WAS OPENED AND THE MEDICAL TEAM WAS ABLE TO REPOSITION AND NOT REMOVE THE SMARTPORT. THE SMARTPORT WAS ASPIRATED, FLUSHED EASILY, AND WAS SECURED TO THE CHEST WALL. PLAINTIFF WAS TRANSFERRED TO THE RECOVERY ROOM AND TOLERATED THE PROCEDURE WELL. ON (B)(6) 2024, PLAINTIFF PRESENTED HERSELF TO DR. (B)(6), AT THE (B)(6). PLAINTIFF STATED THAT THE SMARTPORT WAS AGAIN NOT WORKING AND WAS EXTREMELY PAINFUL DURING THE INFUSIONS. PLAINTIFF WAS DIAGNOSED WITH A DYSFUNCTIONAL PORT. IN AND AROUND

  Patient problems: Implant Pain; Obstruction/Occlusion

  MAUDE report 23057194 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SUPPLY CHAIN EMPLOYEE, AT ST. VINCENT, REPORTED THAT A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER FILLED SH VALVED INTRODUCER WAS PLACED IN A PATIENT OVER A YEAR AGO BUT CAME APART INSIDE THE PATIENT JUST RECENTLY. THE PATIENT REQUIRED AN INTERVENTIONAL PROCEDURE TO RETRIEVE THE TWO SEPARATE PIECES OF CATHETER THAT BECAME DETACHED FROM THE PORT HUB. DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893954 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, REFERENCE NUMBER CT80LPBDVI, LOT NUMBER 5734480. THE DEVICE WAS IMPLANTED BY (B)(6), (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS FOR CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 22588564 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT80L0LPBVD1, LOT NUMBER 5682731. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6). ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER FOR CONCERNS OF PORT SITE SWELLING, FEVER, AND DIZZINESS. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT SHE HAD DEVELOPED AN INFECTION AND THAT THE SMARTPORT WAS THE SOURCE. THE DEFECTIVE DEVICE WAS SUBSEQUENTLY REMOVED BY DR. (B)(6).

  Patient problems: Dizziness; Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 21677421 ↗
• MalfunctionMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2020, PLAINTIFF UNDERWENT RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS VORTEX PRODUCT, MODEL NUMBER MP-MP5SAT, LOT NUMBER 5358791. THE VORTEX WAS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6)., BY DR. (B)(6), M.D. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6). PLAINTIFF'S MEDICAL TEAM ATTEMPTED TO ACCESS HER PORT BUT WAS UNABLE TO DO SO. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT HER VORTEX NEEDED TO BE REMOVED. DR. (B)(6), M.D., ATTEMPTED TO REMOVE THE PORT BUT DISCOVERED IT HAD FRACTURED. DR.(B)(6) WAS UNABLE TO REMOVE THE PORT IN ITS ENTIRETY. ON OR ABOUT, (B)(6) 2020, PLAINTIFF UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE CATHETER FRAGMENT. DR. (B)(6), M.D. SUCCESSFULLY REMOVED THE CATHETER FRAGMENT AND IMPLANTED A NEW PORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21590501 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED THAT A 8F LOW PROFILE PLASTIC VORTEX PORT BECAME DISLODGED AND DURING THE REMOVAL PROCEDURE, THE CATHETER WAS NO LONGER ATTACHED TO THE PORT. THE PATIENT HAD TO HAVE A SEPARATE IR PROCEDURE TO REMOVE THE RETAINED CATHETER. NO FURTHER DETAILS WERE ABLE TO BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21560834 ↗