BioFlo Vortex H787CT80LPPDVI0Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15051684016810), received between Dec 6, 2022 and Jun 12, 2026 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 15, 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 OF A LEFT INTERNAL JUGULAR TUNNELED VENOUS ACCESS PORT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT80LPPDVI, LOT NUMBER 5796676. THE SMARTPORT WAS IMPLANTED AT (B)(6). 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 BLOOD CLOT/PULMONARY EMBOLISM, SEPSIS AND A STAPH EPIDERMIDIS INFECTION CAUSED BY HIS SMARTPORT DEVICE, THAT WAS CONFIRMED AND DIAGNOSED VIA CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) PE (PULMONARY EMBOLISM) PROTOCOL W/WO IV CONTRAST AND BLOOD CULTURES ON (B)(6) 2023. PLAINTIFF THEN SUFFERED ADDITIONAL PULMONARY EMBOLISMS OR THROMBOTIC EVENTS ON OR ABOUT (B)(6) 2025 AND AGAIN IN OR AROUND (B)(6) 2025.

  Patient problems: Pulmonary Embolism; Sepsis; Skin Infection

  MAUDE report 23051185 ↗
• InjuryAug 26, 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 AN ANGIODYNAMICS 8F SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER L0G826145. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF WAS ADMITTED TO (B)(6) HOSPITAL FOR SHORTNESS OF BREATH AND CHEST WALL PAIN. DURING HER EXTENDED HOSPITAL STAY, PLAINTIFF'S SMARTPORT WAS FOUND TO HAVE A PORT INFECTION AND THROMBOSIS THAT REQUIRED PORT REMOVAL AND REPLACEMENT. FOLLOWING PLAINTIFF'S DIAGNOSIS, PLAINTIFFS DEFECTIVE PORT WAS REMOVED AT (B)(6) HOSPITAL REHAB.

  Patient problems: Chest Pain; Dyspnea; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22893668 ↗
• DeathMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE DECEDENT, (B)(6), UNDERWENT PLACEMENT OF THE DEFENDANTS' SMARTPORT POWER INJECTABLE PORT PRODUCT, I.E., SMARTPORT PLASTIC PORT: MODEL/CAT NUMBER: H787CT80LPPDVI0; LOT #: 5708017, FOR HIS CHEMOTHERAPY TREATMENT. UPON INFORMATION AND BELIEF, THE AFOREMENTIONED DEVICE'S DESCRIPTION IS AS FOLLOWS: DETACHED 8F POLY CATH, VI INTRODUCER, & FILLED SH OR SMART PORT PLASTIC, 8F SINGLE PLASTIC PORT FILLED NON-VALVED PG, OR 8FRENCH ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT. UPON INFORMATION AND BELIEF, ON (B)(6) 2021, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD, AT (B)(6) HOSPITAL IN (B)(6), WISCONSIN. UPON INFORMATION AND BELIEF, ON OR ABOUT (B)(6) 2022, THE DECEDENT PRESENTED TO THE EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL IN (B)(6), WISCONSIN, IN AN AMBULANCE, WITH COMPLAINTS OF WEAKNESS, AND WAS THEN ADMITTED WITH PROGRESSIVE WEAKNESS AND OTHER ACCOMPANYING SYMPTOMS. UPON INFORMATION AND BELIEF, ON OR ABOUT (B)(6) 2022, THE CULTURE OF THE DECEDENT'S PORT-A-CATH WAS ORDERED. UPON INFORMATION AND BELIEF, THE DECEDENT'S BLOOD CULTURE AND THE BLOOD CULTURE AEROBIC PANEL CAME BACK AS "ABNORMAL". UPON INFORMATION AND BELIEF, THE DECEDENT'S AFOREMENTIONED "ABNORMAL"

  Patient problems: Bacterial Infection; Endocarditis; Muscle Weakness/Atrophy; Pericardial Effusion

  MAUDE report 21981960 ↗
• InjuryApr 4, 2025Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  A USER FACILITY MEDWATCH WAS RECEIVED REGARDING AN 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. THE FOLLOWING WAS REPORTED: "PATIENT HAD ANGIODYNAMIC VORTEX PORT PLACED IN OR (OPERATION ROOM) ON (B)(6) 202. PATIENT PRESENTED TO ED (EMERGENCY DEPARTMENT) WITH NECK PAIN AND SWELLING. CT (COMPUTED TOMOGRAPHY) RESULT SHOWED DEEP VENOUS THROMBOSIS OF THE RIGHT SUBCLAVIAN, BRACHIOCEPHALIC, AND INTERNAL JUGULAR VEINS WITH ADJACENT INFLAMMATORY CHANGES/THROMBOPHLEBITIS ALONG THE RIGHT INTERNAL VEIN AND ADJACENT TO THE RIGHT-SIDED PORT CATHETER INSERTION SITE. VISIT TO INFUSION CENTER: NO BLOOD RETURN OBTAINED. BASED UPON RESULTS, WILL DELAY CHEMO TREATMENT. PORTAGRAM PERFORMED IN IR (INTERVENTIONAL RADIOLOGY). CATHETER CHECK OF RIGHT-SIDED SUBCUTANEOUS PORT TERMINATES IN THE RIGHT INNOMINATE VEIN. WOULD ADVISE PORT REVISION." DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: Inflammation; Neck Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21773695 ↗
• MalfunctionMar 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A RISK MANAGER SUBMITTED A USER FACILITY MEDWATCH FOR A 8F LOW PROFILE PLASTIC VORTEX PORT DETACHED POLY CATHETER FILLED SH VALVED INTRODUCER. THE FOLLOWING WAS REPORTED: "PATIENT HAD PORT PLACED IN IR. INFUSION RN NOTED PATIENT COMPLAINED AFTER LAST INFUSION HER PORT AREA TURNED RED THEN DARK BROWN. PATIENT ALSO STATED SHE HAS SOME BURNING IN THE NECK AND PAIN WHEN RN FLUSHES PORT. INFUSION GIVEN THROUGH IV AND PORTAGRAM ORDERED FOR MALFUNCTIONING PORT. PATIENT SEEN IN IR, PORTAGRAM DONE. PATIENT SCHEDULED FOR PORT REVISION FOR MALFUNCTIONING CHEST WALL PORT. PATIENTS PORT TO BE REVISED TODAY SO SHE MAY CONTINUE HER TREATMENTS." DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: Burning Sensation; Implant Pain; Skin Discoloration

  MAUDE report 21687228 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6), 2021, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5671711. THE DEVICE WAS IMPLANTED BY (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS. SUBSEQUENTLY THE PORT WAS REMOVED DUE TO INFECTION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21682114 ↗
• InjuryDec 6, 2022Fracture; Migration; Fracture; Migration

  AN END USER REPORTED AN ISSUE WITH AN 8F LOW PROFILE PLASTIC VORTEX PORT . APPROXIMATELY 2 WEEKS AFTER PLACEMENT, WHEN THE PATIENT WENT FOR A CHEMOTHERAPY INFUSION,THE PORT WAS ASSESSED AND A BROWN TINGE WAS PULLED INTO THE SYRINGE. THE DEVICE APPEARED TO BE LEAKING AROUND THE NEEDLE SITE AND SWELLING WAS NOTED ABOVE THE PORT SITE. THE PATIENT WAS SENT FOR A DUE STUDY WHICH CONFIRMED THAT THE PORT CATHETER TUBING HAD DETACHED FROM THE RESERVOIR AND HAD EMBOLIZED INTO THE PATIENT'S HEART AND PULMONARY ARTERY. THE PATIENT REQUIRED RETRIEVAL AND REMOVAL OF THE FRAGMENT WHICH RESULTED IN HOSPITALIZATION. THEY HAVE SINCE RECOVERED AND WERE DISCHARGED FROM THE HOSPITAL THE PRIOR DAY. THE PORT WAS NOT REPLACED.

  Patient problems: Device Embedded In Tissue or Plaque; Swelling/ Edema

  MAUDE report 15923349 ↗