BioFlo VortexRecalls & reported problems across all models

We found 10 models of BioFlo Vortex by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2022 and Sep 30, 2026 — classified as 2 deaths, 17 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BioFlo Vortex problems

BioFlo Vortex models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BioFlo Vortex H787CT80LPPDVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death11 reports
• BioFlo Vortex H787CT80LPBDVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  10 reports
• BioFlo Vortex H787CT80LPPDNFVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• BioFlo Vortex H787CT80LPBDNFVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• BioFlo Vortex H787CT50PTBDVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BioFlo Vortex H787CT60LPBDVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BioFlo Vortex H787CT80LTBAVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death1 report
• BioFlo Vortex H787CT80STBDNFVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BioFlo Vortex H787CT80LTBDVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BioFlo Vortex H787CT60LPBDNFVI0

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report

Recent BioFlo Vortex adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 9, 2026Adverse Event Without Identified Device or Use Problem

  An End User reported an issue with a SMARTPORT 8F SL PLASTIC NON-FILLED DET PU VI. A patient underwent internal jugular insertion of the port and received her first of four, chemotherapy treatments on (b)(6) 2026; consisting of Docetaxel and Cyclophosphamide. Palonosetron and Pegfilgrastim were also delivered as supporting agents. Following the first chemotherapy treatment, the patient developed significant skin reactions and port site inflammation, leading to port removal on (b)(6) 2026, due to a suspected allergy. After port removal, the rash resolved and the patient tolerated the second cycle and G-CSF injection without complications. Despite multiple good faith efforts, no further details have been obtained.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50189039 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2023, PLAINTIFF WAS DIAGNOSED WITH CROHN DISEASE. THE TREATMENT FOR PLAINTIFF'S CROHN DISEASE INCLUDED INTRAVENOUS THERAPY. IN ORDER TO ADMINISTER THE INTRAVENOUS MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HER. ON OR ABOUT (B)(6), 2023, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "SMARTPORT", IDENTIFIED BY THE FOLLOWING: MODEL NUMBER: CT80LPPDVI, LOT NUMBER: 5762021, MANUFACTURER: ANGIODYNAMICS, INC. (B)(6), FOR THE PURPOSES OF PLAINTIFF'S INTRAVENOUS MEDICATIONS AT(B)(6) HOSPITAL IN OHIO. SUBSEQUENT TO THE PLACEMENT OF THE AFOREMENTIONED SMARTPORT, THE PLAINTIFF WAS CAUSED TO DEVELOP AN INFECTION, IDENTIFIED AS BACTEREMIA, WHICH UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. THE PLAINTIFF UNDERWENT MEDICAL TREATMENT FOR THE INFECTION. AS PART OF THIS MEDICAL TREATMENT FOR THE INFECTION, PLAINTIFF WAS ADMITTED TO THE (B)(6) HOSPITAL ON OR ABOUT (B)(6), 2023, FOR TREATMENT OF BACTEREMIA WHICH, UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. AS FURTHER TREATMENT FOR THE INFECTION, ON OR ABOUT (B)(6), 2023, THE PORT CATHETER WAS REMOVED ENTIRELY AT WESTERN RESERVE HOSPITAL.

  Patient problems: Bacteremia

  MAUDE report 25484178 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2022, PLAINTIFF WAS DIAGNOSED WITH AMYLOIDOSIS. THE TREATMENT FOR PLAINTIFF'S AMYLOIDOSIS INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HIS PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HIM. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "SMARTPORT", IDENTIFIED BY THE FOLLOWING: MODEL NUMBER: CT80STBDNFVI, LOT NUMBER: 5722766, MANUFACTURER: ANGIODYNAMICS, INC. 26 FOREST STREET, MARLBOROUGH, MA 01752, FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY AT (B)(6) HOSPITAL IN (B)(6). SUBSEQUENT TO THE PLACEMENT OF THE AFOREMENTIONED SMARTPORT, THE PLAINTIFF WAS CAUSED TO DEVELOP AN INFECTION, IDENTIFIED AS BACTEREMIA, WHICH UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. THE PLAINTIFF UNDERWENT MEDICAL TREATMENT FOR THE INFECTION. AS PART OF THIS MEDICAL TREATMENT FOR THE INFECTION, PLAINTIFF WAS ADMITTED TO (B)(6) MEDICAL CENTER ON OR ABOUT (B)(6) 2022, FOR TREATMENT OF BACTEREMIA WHICH, UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. AS FURTHER TREATMENT FOR THE INFECTIONS, ON OR ABOUT (B)(6) 2022, THE PORT CATHETER WAS REMOVED ENTIRELY AT (B)(6) MEDICA

  Patient problems: Bacteremia

  MAUDE report 25480891 ↗
• MalfunctionMay 15, 2026Malposition of Device

  A MANAGER OF INTERVENTIONAL RADIOLOGY OPS REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER NON-FILLED SH VALVED INTRODUCER. AFTER PORT PLACEMENT, A PATIENT EXPERIENCED LOSS OF ACCESS DUE TO THE PORT FLIPPING WITHIN THE POCKET FOLLOWING IMPLANTATION. THE PORT WAS SAID TO HAVE BEEN SUTURED AT TWO POINTS, WITHIN THE POCKET, USING 2-0 PDS DISSOLVABLE STITCHES. PATIENT WILL UNDERGO AN ADDITIONAL SURGICAL PROCEDURE DUE TO THE PORT FLIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188853 ↗
• 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 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, CT60LPBDNFVI. THE DEVICE WAS IMPLANTED BY DR. (B)(6), DO TO BE USED FOR CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED HERSELF TO (B)(6) WITH A CHIEF COMPLAINT OF FEVER, HYPOTENSION, AND CHILLS, WHERE SHE WAS DIAGNOSED WITH SEPSIS RELATED TO PORT INFECTION.

  Patient problems: Bacterial Infection; Chills; Fever; Low Blood Pressure/ Hypotension; Sepsis

  MAUDE report 24841557 ↗
• MalfunctionApr 10, 2026Malposition of Device; Infusion or Flow Problem

  A RISK MANAGER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. THE PORT WAS IMPLANTED WITH 2-0 PDS SUTURES, BY A THORACIC SURGEON. WHEN THE PATIENT PRESENTED FOR AN INFUSION, THE PORT WAS UNABLE TO BE ACCESSED; THEREFORE, THE PATIENT WAS TRANSFERRED TO INTERVENTION RADIOLOGY FOR A PORTOGRAM. THE RESULTS OF THE PORTOGRAM WERE DICTATED AS FOLLOWS: "CATHETER CHECK OF RIGHT-SIDED SUBCUTANEOUS PORT DEMONSTRATES NORMAL COURSE WITH PATENCY. SLIGHT ANGULATION OF THE PORT RESERVOIR AND MOBILITY WITHIN THE PORT POCKET SUGGESTS POTENTIAL INTERMITTENT PORT FLIPPING." SUBSEQUENTLY, THE PATIENT HAD TO UNDERGO AN ADDITIONAL SURGERY TO HAVE THE PORT REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841555 ↗
• MalfunctionApr 8, 2026Detachment of Device or Device Component

  A NURSE REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. DURING THE PORT PLACEMENT PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED AND CURRENTLY REMAINS IN THE PATIENT. THE PATIENT HAS NOT EXERPERIENCED ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT; THEREFORE, THERE ARE NO PLANS TO REMOVE THE FRAGMENT, FROM THE PATIENT, AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 24817764 ↗
• MalfunctionMar 30, 2026Fracture

  ON OR ABOUT (B)(6), 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS 8F SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5743897. THE DEVICE WAS IMPLANTED BY DR. DAVID C. LYNN, MD AT (B)(6) HOSPITAL IN (B)(6) WISCONSIN, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY ADMINISTRATION. ON OR ABOUT (B)(6), 2023, PLAINTIFF WAS ADMITTED TO (B)(6) HOSPITAL FOR CHEST WALL PAIN. DURING HER EXTENDED HOSPITAL STAY, PLAINTIFF'S SMARTPORT WAS FOUND TO HAVE PORT LEAKAGE AND FIBRIN SHEATH OF THE PORT CATHETER THAT REQUIRED PORT REMOVAL AND REPLACEMENT. ON OR ABOUT (B)(6), 2023 FOLLOWING PLAINTIFF'S DIAGNOSIS, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED AT (B)(6) HOSPITAL BY DR. (B)(6) M.D. ON OR ABOUT (B)(6), 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS 8F SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5748718. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D. AT (B)(6) HOSPITAL WISCONSIN, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY ADMINISTRATION.

  Patient problems: Chest Pain; Extravasation

  MAUDE report 24728675 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2024, PLAINTIFF (B)(6) UNDERWENT AN INSERTION OF A RIGHT INTERNAL JUGULAR VEIN CENTRAL VENOUS ACCESS PORT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT80LPPDVI, LOT NUMBER 5826522. UPON INFORMATION AND BELIEF, THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED AT (B)(6) IN (B)(6). ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED TO (B)(6) FOR PAIN AND WAS DIAGNOSED WITH AN INFECTION CAUSED BY HER SMARTPORT DEVICE. THIS ULTIMATELY RESULTED IN THE REMOVAL OF HER SMARTPORT DEVICE ON (B)(6) 2024, AT (B)(6).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24678220 ↗
• 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 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2023, (B)(6) UNDERWENT AN INSERTION AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER: H787CT80LTBDVI0, LOT NUMBER: LOG718309. UPON INFORMATION AND BELIEF, THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6) FOR MEDICATION AND IMMUNOTHERAPY TREATMENT. (B)(6) 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 DECEDENT'S BLOODSTREAM. MOREOVER, DECEDENT'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 ON (B)(6) 2023, (B)(6) PRESENTED TO (B)(6) HOSPITAL IN (B)(6) WITH COMPLAINTS OF FEVERS AND CHILLS. HE REMAINED IN THE HOSPITAL UNTIL ON (B)(6) 2023. DURING THIS HOSPITAL STAY, (B)(6) WAS DIAGNOSED WITH AN ENTEROCOCCUS FAECALIS BACTERMIA INFECTION WITH ENDOCARDITIS AND SEPSIS, WHICH HIS DOCTORS TOLD HIM WAS CAUSED BY HIS SMARTPORT. WHILE (B)(6) DOCTORS ELECTED NOT TO REMOVE HIS SMARTPORT AT THAT TIME DUE TO CERTAI

  Patient problems: Bacteremia; Endocarditis; Sepsis

  MAUDE report 23850078 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF THE DEFECTIVE DEVICE. THE DEFECTIVE DEVICE WAS IMPLANTED AT (B)(6) FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF NAUSEA AND VOMITING. BLOOD CULTURES RETURNED POSITIVE FOR MRSA, CONFIRMING SEPSIS. REMOVAL OF THE DEFECTIVE DEVICE WAS RECOMMENDED. ON OR ABOUT (B)(6) 2024. PLAINTIFF'S DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), MD AT (B)(6).

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 23828457 ↗
• 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 ↗

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