BioFlo Vortex CT80LPPDVIRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI H787CT80LPPDVI0), received between Jan 29, 2021 and Mar 6, 2025 — classified as 8 injuries, 8 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, 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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  10 DAYS AFTER A BIOFLO VORTEX PORT PLACEMENT, THE PATIENT WAS EXPERIENCING PAIN AND THERE WAS DIFFICULTY FLUSHING OR ASPIRATING THE PORT. UPON EVALUATION IT WAS REPORTED THE CATHETER HAD DETACHED FROM THE PORT AND MOVED INTO LEFT SUBCLAVIAN. THE PATIENT REQUIRED SURGICAL REMOVAL OF THE CATHETER AND A REPLACEMENT DEVICE WAS PLACED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17071829 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING PHYSICIAN REPORTED THEY HAD A PATIENT HARMED BY A PORT FROM A AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER KIT. AFTER ONLY 3.5 MONTHS OF PLACEMENT, THE PORT WAS DIFFICULT TO ASPIRATE AND ERODED THROUGH THE PATIENT'S SKIN. THIS ISSUE RESULTED IN THE PORT NEEDING TO BE REMOVED. THE POCKET WAS PACKED (ONGOING), LEAVING IT OPEN TO HEAL BY SECONDARY INTENTION. BLOOD CULTURES WERE NEEDED DUE TO RISK OF POTENTIALLY LETHAL INFECTION DUE TO OPEN WOUND IN IMMUNOCOMPROMISED ONCOLOGY PATIENT, AND RESULTING IN DELAY OF CHEMOTHERAPY FOR METASTATIC DISEASE (CHEMOTHERAPY WAS SUSPENDED). UPON EXPLANTATION, AFTER ONLY A 3.5 MONTH DWELL TIME, THERE WAS VERY AGGRESSIVE INGROWTH OF FIBRINOUS MATERIAL INTO THE PORT CATHETER TIP LUMEN ITSELF.

  Patient problems: Skin Erosion

  MAUDE report 14852091 ↗
• MalfunctionSep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION: THE SHEATH HAS BEEN PEELED PROPERLY, BUT NEEDED HEAVY FORCE TO BREAK IT APART. THE OPENING OF THE SHEATH WAS WHERE THE PHYSICIAN RECEIVED THE CUT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12407811 ↗
• MalfunctionJan 29, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AN END USER REPORTED AN ISSUE WITH A 8F LOW PROFILE PLASTIC VORTEX PORT. AFTER IMPLANTATION, IT WAS NOTED THAT THE PORT WOULD NOT INITIALLY FLUSH OR ASPIRATE; HOWEVER, AFTER A FEW ATTEMPTS, ASPIRATION AND FLUSHING WAS ACHIEVED. THE SURGEON LATER REPORTED RECEIVING COMPLAINTS FROM THE INFUSION CENTER WHO STATED THEY WERE HAVING A LOT OF DIFFICULTY ASPIRATING. A DIE STUDY WAS COMPLETED BUT SHOWED NO SIGNS OF EXTRAVASATION OR CATHETER LEAKING. THROMBOLYTIC TPA WAS ADMINISTERED BUT ASPIRATION WAS STILL NOT ACHIEVED. A NEW PORT WAS ORDERED AND THIS PORT WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252317 ↗