BioFlo VortexRecalls & reported problems across all models

We found 5 models of BioFlo Vortex by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2020 and Mar 6, 2025 — classified as 12 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

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

• BioFlo Vortex CT80LPPDVI

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  16 reports
• BioFlo Vortex CT80LPBDVI

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 reports
• BioFlo Vortex CT60LPBDVI

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• BioFlo Vortex CT60LPBDNFVI

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• BioFlo Vortex CT80STBDVI

  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.

• InjuryMar 6, 2025Complete Blockage; Complete Blockage

  AN RISK MANAGER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCERS. COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED THROMBUS AT THE DISTAL ASPECT OF THE PORT CATHETER, IN THE PATIENT'S RIGHT ATRIUM, DESPITE TPA AND CATHFLO USAGE. THE PATIENT REQUIRED REMOVAL AND REPLACEMENT OF THE DEVICE. DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS WERE OBTAINED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21537627 ↗
• InjuryMar 6, 2025Malposition of Device; Infusion or Flow Problem; Malposition 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. IT WAS REPORTED THAT THE PATIENT HAD THIS PORT PLACED FOR CHEMOTHERAPY. DURING PREPARATION FOR TREATMENT, AN INFUSION NURSE WAS UNABLE TO ACCESS THE PORT AND THE PATIENT REPORTED SORENESS AROUND THE PORT, WITH NECK SWELLING. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR A PORTOGRAM WHICH SHOWED THE PORT HAD FLIPPED AND THERE WAS A BLOOD CLOT NOTED IN THE RIGHT INTERNAL JUGULAR. ULTIMATELY, THE PORT WAS REMOVED AND REPLACED. IT WAS NOTED THAT THE PORT HAD NOT BEEN SUTURED IN PLACE, AS DIRECTED IN THE DEVICE'S DIRECTIONS FOR USE (DFU).

  Patient problems: Implant Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21536717 ↗
• MalfunctionMar 6, 2025Malposition of Device; Malposition of Device

  AN END USER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. IT WAS REPORTED THAT THE PATIENT'S PORT THAT FLIPPED BUT WAS ABLE TO BE SUCCESSFULLY MANIPULATED UNDER FLUORO. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT. IT WAS NOTED THAT THE PORT HAD NOT BEEN SUTURED IN PLACE, AS DIRECTED IN THE DEVICE'S DIRECTIONS FOR USE (DFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536551 ↗
• MalfunctionFeb 19, 2025Malposition of Device; Malposition of Device

  AN INTERVENTIONAL RADIOLOGY MANAGER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. THE PORT HAD TO BE REPLACED DUE TO THE CATHETER MIGRATING BACK UP AND KINKING. WHEN THE PORT WAS REMOVED, IT WAS INTACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412172 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, DECEDENT UNDERWENT PLACEMENT OF THE ANGIODYNAMICS PORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5732866. THE DEVICE WAS IMPLANTED BY (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, DECEDENT PRESENTED TO (B)(6) 2024, WITH COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. DECEDENT WAS DIAGNOSED WITH PLEURAL EFFUSION AND AN INFECTION. DUE TO DECEDENT'S POSITIVE BLOOD CULTURES, HER MEDICAL TEAM DETERMINED THAT THE DEFECTIVE PORT HAD TO BE REMOVED AND SHOULD NOT BE REPLACED. ON OR ABOUT (B)(6) 2022, DR. (B)(6), M.D., REMOVED DECEDENT'S DEFECTIVE PORT AT (B)(6).

  Patient problems: Bacterial Infection; Chest Pain; Dyspnea; Pleural Effusion

  MAUDE report 20903848 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, M.A. UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT+ PRODUCT, MODEL/CAT. NUMBER CT80STBDVI, LOT NUMBER 5733965. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMARTPORT+ STANDARD PORT WITH ENDEXO AND VORTEX TECHNOLOGY. THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), DO., AT (B)(6) HOSPITAL, IN (B)(6), KANSAS, FOR M.A.'S ECT. ON OR ABOUT (B)(6) 2022, A CT CHEST ABDOMEN W/CONTRAST PROCEDURE ADMINISTERED TO M.A. REVEALED THE PRESENCE OF THROMBUS IN M.A.'S BRACHIOCEPHALIC VEIN AND SUPERIOR VENA CAVA. THE THROMBUS AT ISSUE WAS DETERMINED TO BE ASSOCIATED WITH M.A.'S SMARTPORT. ON OR ABOUT (B)(6) 2022, M.A. WAS DIAGNOSED WITH "PARTIALLY OCCLUDING DEEP VENOUS THROMBOSIS RIGHT VEIN." AFTER FURTHER EVALUATION, M.A.'S MEDICAL TEAM DISCUSSED M.A.'S SMARTPORT REMOVAL, BUT IT POSTPONED THE REMOVAL OF THE DEFECTIVE CATHETER AT THAT TIME DUE TO THE CONCERN REGARDING BLEEDING WHILE M.A. WAS STILL ON THE PRESCRIBED ANTICOAGULANT THERAPY. ON (B)(6) 2023, M.A. RETURNED TO (B)(6) HOSPITAL IN (B)(6), FOR REMOVAL OF THE DEFECTIVE PORT-A-CATH, WHICH, UPON INFORMATION AND BELIEF, WAS REMOVED BY DR. (B)(6), DO. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20792082 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ASSOCIATE DIRECTOR OF PERIOPERATIVE SERVICES REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. THE FOLLOWING WAS REPORTED: "CATHETER WAS ATTACHED TO THE PORT WITH THE CLAMP UPON SUTURING THE PORT CATH BECAME DISCONNECTED FROM THE CLAMP. DR. (B)(6) HAD TO DO FURTHER DISSECT TO RETRIEVE CATH. MD WAS ABLE TO RETRIEVE AND THE CATH AND THE CATH WAS REMOVED WITH PORT AND CLAMP. ALL ITEMS WERE REMOVED FROM FIELD AND SAVED. NEW PORT WAS OPENED AND IMPLANTED CORRECTLY." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20600862 ↗
• InjuryOct 28, 2024Adverse 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 AN ANGIODYNAMICS VORTEX PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5767189. THE DEVICE WAS IMPLANTED BY DR.(B)(6), M.D., AT (B)(6) IN (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), AFTER A HOME NURSE SWABBED HER PORT DUE TO TENDERNESS AT THE PORT SITE. BLOOD CULTURES TESTED POSITIVE FOR ACINETOBACTER. PLAINTIFF WAS SEEN AT (B)(6), WHERE ADDITIONAL BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR PSEUDOMONAS PUTIDA. PLAINTIFF WAS DISCHARGED WITH ANTIBIOTICS. ON OR ABOUT (B)(6) 2023, PLAINTIFF RETURNED TO (B)(6), WHERE REPEAT BLOOD CULTURES WERE DRAWN AND WERE ONCE AGAIN POSITIVE. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE PORT WAS THE SOURCE OF THE INFECTION AND THAT THE DEFECTIVE PORT NEEDED TO BE REMOVED. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. DAVID TUNER, M.D., AT UK ALBERT B. CHANDLER HOSPITAL. AS A RESULT OF HAVING THE VORTEX IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERG

  Patient problems: Bacterial Infection

  MAUDE report 20549268 ↗
• InjuryOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. DURING A PROCEDURE, THE PHYSICIAN INSERTED THE PORT; HOWEVER, THE CATHETER DETACHED AND MIGRATED INTO THE PATIENT'S VESSEL. ULTIMATELY, THE PORT WAS REMOVED; HOWEVER, IT IS CURRENTLY UNKNOWN HOW THIS EVENT AFFECTED THE PATIENT. DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20527352 ↗
• InjuryOct 20, 2024Fracture; Migration; Fracture; Migration

  AN END USER REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. DURING A PORT REMOVAL PROCEDURE, THE CATHETER DETACHED AND TRAVELED DEEPER TOWARDS THE PATIENT'S HEART. THE PATIENT WAS BROUGHT INTO THE OR AND THEN TRANSFERRED TO ANOTHER HOSPITAL, IN THE CITY, TO HAVE THE FRAGMENT REMOVED BY INTERVENTIONAL RADIOLOGY. THIS OCCURRED ON (B)(6) 2024. ULTIMATELY, THE FRAGMENT WAS REMOVED AND THE PATIENT IS, REPORTEDLY, DOING WELL. DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS WERE OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20490259 ↗
• MalfunctionJul 26, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCERS. IT WAS REPORTED THAT THE VALVED INTRODUCER SHEATHS ARE BREAKING AT THE HUB, WHILE INSIDE OF THE PATIENT(S). IT WAS REPORTED THAT THIS HAS HAPPENED WITH MULTIPLE KITS. THE PROCEDURES WERE COMPLETED WITH DIFFERENT DEVICES AND NO ADVERSE EFFECTS OR HARM WAS EXPERIENCED BY THE PATIENTS. DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838229 ↗
• MalfunctionJul 1, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  A SURGEON REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. AFTER PORT PLACEMENT, THE PATIENT WAS SENT TO THE PACU AND WHEN A HEALTH PROFESSIONAL ATTEMPTED TO ACCESS THE PORT, THE CATHETER WAS FOUND TO HAVE DISLODGED INTO THE PATIENT'S SVC. ULTIMATELY, THE PATIENT REQUIRED REMOVAL OF THE CATHETER FROM THEIR SVC. DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644611 ↗
• InjuryApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS RECEIVED A LEGAL SUMMONS REGARDING AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. THE FOLLOWING WAS REPORTED: ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS BIOFLO VORTEX PORT. THE DEVICE WAS IMPLANTED BY DR. TAHA MALLICK, M.D., AT TUG VALLEY ARH IN SOUTH WILLIAMSON, KENTUCKY, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HIMSELF TO TUG VALLEY ARH FOR PORT REMOVAL DUE TO FLUID LEAKAGE ASSOCIATED WITH THE BIOFLO VORTEX. DURING REMOVAL OF THE DEFECTIVE DEVICE, PLAINTIFF'S MEDICAL TEAM DISCOVERED THE CATHETER HAD DISCONNECTED FROM THE PORT AND COULD NOT BE LOCATED. PLAINTIFF WAS IMMEDIATELY TRANSFERRED TO PIKEVILLE MEDICAL CENTER TO UNDERGO AN ADDITIONAL PROCEDURE TO LOCATE AND REMOVE THE CATHETER FRAGMEN T. PLAINTIFF UNDERWENT RETRIEVAL OF THE DISLODGED CATHETER THAT MIGRATED TO THE SUPERIOR VENA CAVA EXTENDING THROUGH THE RIGHT ATRIUM INTO THE RIGHT VENTRICLE. THE CATHETER FRAGMENT WAS RETRIEVED BY DR. STEVEN J. KROHMER, M.D., AT PIKEVILLE MEDICAL CENTER IN PIKEVILLE, KENTUCKY. AS A RESULT OF HAVING THE BIOFLO VORTEX IMPLANTED, PLAINTIFF HAS EXPERIENCED SIGN

  Patient problems: Deformity/ Disfigurement; Foreign Body In Patient; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 19041022 ↗
• MalfunctionMar 4, 2024Infusion or Flow Problem; Infusion or Flow Problem

  AN END USER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED BIOFLO CATHETER FILLED SH VALVED INTRODUCER. A FEW WEEKS FOLLOWING PORT PLACEMENT, THE PATIENT ARRIVED FOR A CHEMOTHERAPY INFUSION; HOWEVER, NURSES WERE UNABLE TO ESTABLISH BLOOD RETURN. THE PATIENT WAS UNABLE TO RECEIVE TREATMENT AND HAS BEEN SCHEDULED FOR A REMOVAL AND REPLACEMENT PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827628 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 2 WEEKS AFTER A 6F LOW PROFILE PLASTIC BIOFLO VORTEX PORT IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF AN INFECTION ALONG THE PORT TRACT AND IN THEIR NECK. THE PATIENT WAS PLACED ON AN ANTIBIOTIC TREATMENT AND SEEMED TO IMPROVE; HOWEVER, ONCE THE ROUND OF ANTIBIOTICS WAS COMPLETED, THE PATIENT DEVELOPED A FEVER. A DIFFERENT ANTIBIOTIC WAS PRESCRIBED AND THE DECISION WAS MADE TO REMOVE THE PORT. CULTURES OF THE PORT POCKET WERE NEGATIVE AND THE PORT HAD NOT YET BEEN USED FOR TREATMENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 17596091 ↗

Other Navilyst Medical, Inc. products

• BioFlo87 models · 520 reports
• Vortex14 models · 71 reports · 1 recall
• AngioDynamics16 models · 119 reports
• NAMIC41 models · 79 reports
• Xcela39 models · 79 reports
• Exodus12 models · 59 reports
• StarBurst Talon3 models · 22 reports