Smart Port CT H787CT80STPDVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 15051684018166), received between Nov 1, 2023 and Sep 27, 2026 — classified as 1 death, 33 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K062414); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50909966 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak; No Flow

  On or about (b)(6)2024, Plaintiff underwent placement of an AngioDynamics SmartPort product, reference number H787CT80STPDVI1, lot number A4123002. The device was implanted by(b)(6) at (b)(6) for vascular access.On or about (b)(6)2024, Plaintiff's port was non-functional and noted to be leaking.On or about (b)(6)2024, Plaintiff's SmartPort was removed by (b)(6) at (b)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876708 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2024, Plaintiff underwent placement of an Angio Dynamics Smart Port product, reference number H787CT80STPDVI1, lot number A4423039. The device was implanted by Dr. (b)(6), MD at (b)(6) for the purpose of providing vascular access.On or about (b)(6) 2024, Plaintiff was diagnosed with an infection, and port removal was recommended.On or about (b)(6) 2024, Plaintiff's port was removed by Dr. (b)(6), MD at (b)(6).

  Patient problems: Unspecified Infection

  MAUDE report 50876707 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2022, Plaintiff underwent placement of an AngioDynamics SmartPort product, reference number (b)(4), and lot number 5730877. The device was implanted by Dr. (b)(6) MD (b)(6) in (b)(6) for the purpose of providing Chemotherapy.On or about (b)(6) 2022 Plaintiff was diagnosed with an infection, and port removal was recommended.On or about (b)(6)2022, Plaintiff's infected port was removed by Dr. (b)(6) MD at (b)(6).

  Patient problems: Bacterial Infection

  MAUDE report 50863275 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2023, Decendent underwent placement of the AngioDynamics SmartPort port catheter product, with model number H787CT80STPDVI1, and lot number 5775239.The SmartPort device was implanted by Dr. (b)(6) at (b)(6) Medical Center in (b)(6) for the purpose of ongoing medical treatment.On or about (b)(6) 2024, Decendent was admitted to (b)(6) Medical Center for vaso occlusive crisis with fever. Decendent was diagnosed with bacteremia in the right SmartPort and subsequently underwent removal of the SmartPort on (b)(6) 2024. The procedure was performed by Dr. (b)(6).

  Patient problems: Bacteremia

  MAUDE report 50064010 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, SERIAL NUMBER (B)(6) LOT NUMBER A0724047. THE DEVICE WAS IMPLANTED BY (B)(6) MD, (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO DEEP VENOUS THROMBOSIS. PLAINTIFF DID NOT DISCOVER THE HEIGHTENED RISK OF DEEP VENOUS THROMBOSIS RELATED TO SMART PORT DEFECTS UNTIL (B)(6) 2024, WHEN SHE SAW AN AD REGARDING THE ANGIODYNAMICS' DEFECTIVE PRODUCTS LITIGATION AND RETAINED (B)(6).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25089354 ↗
• InjuryMar 24, 2026Malposition of Device

  ON OR ABOUT ON (B)(6) 2025, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER: H787CT80STPDVI1, AND LOT NUMBER: A2424029. THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6), MD., AT (B)(6), FOR THE PURPOSE OF REPLACING ANOTHER CLOGGED PORT THAT WAS USED FOR TREATING MOG ANTIBODY DISEASE. ON OR ABOUT ON (B)(6) 2025, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF A SHORTNESS OF BREATH, LEFT ARM PAIN, NAUSEA, LIGHTHEADEDNESS, SWEATING, AND MALAISE. A CT CHEST ANGIOGRAM SHOWED MULTIPLE PULMONARY EMBOLISMS IN THE RIGHT LOWER LUNG AS WELL AS IT WAS NOTED THAT THE PORT CATHETER EXTENDS INTO THE RIGHT VENTRICLE, WHICH RAISES CONCERN THAT THIS MAY BE THE SOURCE FOR THE PULMONARY EMBOLISM. THIS WOULD REQUIRE REMOVAL OF THE SMARTPORT. ON OR ABOUT ON (B)(6) 2025, PLAINTIFF UNDERWENT REMOVAL OF THE SMARTPORT. THE PROCEDURE WAS PERFORMED BY (B)(6), M.D., PH.D. AT (B)(6).

  Patient problems: Dizziness; Dyspnea; Hot Flashes/Flushes; Limb Pain; Malaise; Nausea; Pulmonary Embolism

  MAUDE report 24678228 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT LEFT SUBCLAVIAN VEIN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT PORT CATHETER PRODUCT, WITH MODEL NUMBER, CT80STPDVI1, AND LOT NUMBER, 4679759. SMARTPORT WAS IMPLANTED BY DR. (B)(6). ON OR ABOUT (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF PAIN AROUND THE PORT SITE AND WAS DIAGNOSED WITH AN INFECTION. ON OR ABOUT (B)(6) 2015, WHILE AT (B)(6), PLAINTIFF UNDERWENT REMOVAL OF THE INFECTED AND DEFECTIVE SMARTPORT. THE PROCEDURE WAS PERFORMED BY DR. (B)(6).

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 24671269 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT SINGLE TITANIUM PORT SYSTEM IN THE LEFT INTERNAL JUGULAR, WITH MODEL NUMBER CT80STPDVI1 AND LOT NUMBER A2724041. THIS SMARTPORT DEVICE IS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6). DEFENDANTS MANUFACTURED, SOLD, AND/OR DISTRIBUTED THE SMARTPORT TO PLAINTIFF, THROUGH PLAINTIFF'S IMPLANTING PHYSICIAN(S), TO BE USED FOR VEIN ACCESS. ON OR ABOUT (B)(6) 2025, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF PROGRESSIVE MALAISE, LEFT CHEST SWELLING, AND TENDERNESS AT THE PORT SITE. PLAINTIFF UNDERWENT BLOOD CULTURES, WHICH ULTIMATELY IDENTIFIED AN INFECTION. ON OR ABOUT (B)(6) 2025, PLAINTIFF UNDERWENT SURGERY TO REMOVE THE DEFECTIVE SMARTPORT. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Discomfort; Malaise; Swelling/ Edema; Unspecified Infection

  MAUDE report 24671267 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT AT (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING IV CHEMOTHERAPY. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF GENERALIZED WEAKNESS THAT BECAME PROGRESSIVELY WORSE OVER TWO DAYS. PLAINTIFF WAS DIAGNOSED WITH SEPSIS POSSIBLY DUE TO BACTERIAL PNEUMONIA IN IMMUNOCOMPROMISED PATIENT ON CHEMOTHERAPY. THE DEFECTIVE DEVICE WAS REMOVED BY (B)(6), DO ON (B)(6) 2024. PLAINTIFF WAS ALSO DIAGNOSED WITH BACTEREMIA WITH POSITIVE MRSA AND CEREBROVASCULAR ACCIDENT DUE TO THROMBOSIS OF PRECEREBRAL ARTERY.

  Patient problems: Bacteremia; Muscle Weakness/Atrophy; Pneumonia; Sepsis; Thrombosis/Thrombus

  MAUDE report 24568969 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF ANOTHER ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5643865. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6). FOR VASCULAR ACCESS. ON OR ABOUT (B)(6) 2022, PLAINTIFF WAS DIAGNOSED WITH RARE STAPHYLOCOCCUS AUREUS, AND PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2022, PLAINTIFF'S PORT WAS REMOVED BY. DR. (B)(6), MD AT (B)(6).

  Patient problems: Bacterial Infection

  MAUDE report 24562693 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER CT80STPDVI1, LOT NUMBER 53444462. THE DEVICE WAS IMPLANTED BY DR.(B)(6), MD AT (B)(6) FOR VASCULAR ACCESS. ON OR ABOUT (B)(6) 2019, PLAINTIFF WAS DIAGNOSED WITH SUBCUTANEOUS EDEMA OVER THE RIGHT CHEST PORT AND WAS DIAGNOSED WITH A SUPERFICIAL INFECTION. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO THE EMERGENCY DEPARTMENT WITH ONGOING INFECTION. ON OR ABOUT (B)(6) 2019, PLAINTIFF WAS DIAGNOSED WITH STAPHYLOCOCCUS AUREUS. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2019, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6).

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 24562685 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF ANOTHER ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: H787CT80STPDVI1, LOT NUMBER: 5652773. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6). ON OR ABOUT ON (B)(6) 2021, PLAINTIFF WAS DIAGNOSED WITH A PORT INFECTION. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF WAS NOTED TO HAVE A NONOCCLUSIVE THROMBUS IN THE SUPERIOR VENA CAVA AND LEFT BRACHIOCEPHALIC VEIN. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6). UPON REMOVAL, THE RIGHT INTERNAL JUGULAR VEIN WAS NOTED TO BE SONOGRAPHICALLY THROMBOSED. NEEDLE ACCESS ANGIOGRAM OF THE RIGHT INTERNAL JUGULAR VEIN CONFIRMED THROMBOSIS WITH OCCLUSION OF THE RIGHT BRACHIOCEPHALIC VEIN.

  Patient problems: Bacterial Infection; Thrombosis/Thrombus

  MAUDE report 24562603 ↗
• InjuryMar 10, 2026Difficult to Flush; Fracture

  ON OR ABOUT ON (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: H787CT80STPDVI1. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6). ON OR ABOUT ON (B)(6) 2021, PLAINTIFF'S PORT WAS NOTED TO HAVE DIFFICULTY FLUSHING AND WAS NOT GIVING BLOOD RETURN. A PORT VENOGRAM DEMONSTRATED LEAKAGE OF CONTRAST ALONG THE CATHETER INTO THE RIGHT NECK. ULTRASOUND IMAGING OF THE RIGHT INTERNAL JUGULAR VEIN DEMONSTRATED OCCLUSION. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6).

  Patient problems: Extravasation; Thrombosis/Thrombus

  MAUDE report 24562601 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT RIGHT INTERNAL JUGULAR PLACEMENT OF DEFENDANT'S SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER H787CT80STPDVI, AND LOT NUMBER 5673775. THIS SMARTPORT DEVICE INCLUDES A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6). ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO THE EMERGENCY ROOM AT (B)(6), WITH COMPLAINTS OF PAIN AND REDNESS AT THE PORT SITE. UPON EVALUATION, PLAINTIFF WAS DIAGNOSED WITH AN ERODED PORT. PLAINTIFF WAS TREATED, AND SHE WAS DISCHARGED. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER WITH COMPLAINTS OF FEVER, HEADACHES, VOMITING AND DIARRHEA. BASED ON PLAINTIFF'S SYMPTOMS, THERE WAS A CONCERN THAT SHE MAY BE SUFFERING FROM AN INFECTION, NECESSITATING REMOVAL OF THE SMARTPORT. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER, IN (B)(6) FOR REMOVAL OF THE SMARTPORT SECONDARY TO SUSPECTED INFECTION, AND THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D

  Patient problems: Bacterial Infection; Diarrhea; Fever; Headache; Implant Pain; Skin Discoloration; Skin Erosion; Vomiting

  MAUDE report 24562600 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER H787CT80STPDVI1, LOT NUMBER 519732. THE SMARTPORT WAS IMPLANTED ON THE RIGHT SIDE OF HIS CHEST BY DR. (B)(6). (B)(6) HOSPITAL. IN OR ABOUT (B)(6) 2019, (B)(6) 2020, PLAINTIFF PRESENTED TO THE (B)(6) HOSPITAL WITH SWELLING AND PAIN IN HIS RIGHT ARM AND NECK AS WELL AS SIGNIFICANT AXILLARY TENDERNESS. HIS MEDICAL TEAM DETERMINED THAT HE BEGAN WITH ACUTE DEEP VEIN THROMBUS INVOLVING PORTIONS OF THE RIGHT INTERNAL JUGULAR VEIN, RIGHT SUBCLAVIAN VEIN AND RIGHT AXILLARY VEIN AND THEN ESCALATED TO CHRONIC DEEP VEIN THROMBOSIS AND THAT SMARTPORT WAS THE SOURCE OF THE THROMBOSIS. THE DEFECTIVE PORT WAS SUBSEQUENTLY REMOVED IN (B)(6) 2020.

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

  MAUDE report 24479718 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO ADVENTHEALTH ORLANDO IN ORLANDO, FLORIDA TO UNDERGO PLACEMENT OF AN ANGIODYNAMICS SMART PORT IN THE LEFT INTERNAL JUGULAR VEIN, WITH MODEL NUMBER H787CT80STPDVI1 AND LOT NUMBER 5715889. THIS SMART PORT PRODUCT IS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6). ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6), WITH SYMPTOMS OF SEPSIS. BLOOD CULTURE RETURNED POSITIVE FOR MSSA, NECESSITATING REMOVAL OF THE SMART PORT. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE SMART PORT. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Sepsis

  MAUDE report 24316852 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2017, (B)(6). UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT PRODUCT, MODEL NO. H787CT80STPDVI1 LOT NO. 5038772. THE DEVICE WAS IMPLANTED BY (B)(6), MD., (B)(6) HOSPITAL, TO BE USED FOR BLOOD TRANSFUSIONS FOR SICKLE CELL DISEASE. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL WITH A CHIEF COMPLAINT OF PAIN AND TENDERNESS AT PORT SITE, WHERE PLAINTIFF WAS DIAGNOSED WITH SEPSIS FROM PORT INFECTION.

  Patient problems: Sepsis

  MAUDE report 24296842 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER H787CT80STPDVI1, LOT NUMBER A26240002. THE SMARTPORT WAS IMPLANTED BY (B)(6) IN OR ABOUT (B)(6) 2025, PLAINTIFF PRESENTED TO THE (B)(6) WITH CONCERNS RELATED TO HER PORT SITE. HER MEDICAL TEAM DETERMINED THAT SHE HAD DEVELOPED AN INFECTION AND THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION. THE DEFECTIVE PORT WAS SUBSEQUENTLY REMOVED.

  Patient problems: Medical device site infection

  MAUDE report 24039054 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, (B)(6). UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT CT DEVICE, CATALOG#: H787CT80STPDVI1, LOT#: 5536689. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMARTPORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66CM POLYURETHANE CATHETER AND 8 F INTRODUCER KIT. THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL, IN (B)(6), FOR THE CHEMOTHERAPY TREATMENT OF PLAINTIFF'S BREAST CANCER. ON OR AROUND ON (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6) WITH FEVER. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT A CULTURE TESTING WAS NEEDED. CULTURE TESTING CONFIRMED STAPHYLOCOCCUS AUREUS IN THE POCKET OF PLAINTIFF'S SMARTPORT CT. ON OR AROUND ON (B)(6) 2020, (B)(6) DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), D.O., AT (B)(6) HOSPITAL, IN (B)(6). UPON INFORMATION AND BELIEF, THERE WAS A BLOOD CLOT WITHIN - AND EXTRUDED FROM - THE CATHETER, WHICH WAS SENT IN THE CULTURETTE. AFTER REMOVAL OF THE DEFECTIVE SMARTPORT CT PORT-A-CATH, PLAINTIFF DID NOT HAVE AN OPPORTUNITY TO CONSULT WITH DR. (B)(6), D.O., ABOUT THE CAUSES OF HER CATHETER INFECTION. PLAINTIFF DID NOT DISCOVER THE HEIGHTENED RISK OF INFECTIONS RELATED TO

  Patient problems: Bacterial Infection; Thrombosis/Thrombus

  MAUDE report 23736765 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMART PORT CT DEVICE, CATALOG # CT80STPD-VI, LOT # 5763794. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66CM POLYURETHANE CATHETER AND 8 F INTRODUCER KIT. THE DEVICE AT ISSUE WAS IMPLANTED BY (B)(6), PA-C, AT (B)(6) FOR THE CHEMOTHERAPY TREATMENT OF PLAINTIFF'S LUNG CANCER. ON OR AROUND (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) WITH A CHIEF COMPLAINT OF ARM PAIN WHERE FURTHER TESTING AND IMAGING WERE TAKEN. IT WAS DETERMINED BY DR. (B)(6), DO THAT PLAINTIFF HAD ACUTE THROMBOSIS OF THE RIGHT SUBCLAVIAN VEIN AND RIGHT INTERNAL JUGULAR VEIN, TWO BLOOD CLOTS, IN RELATION TO THE SMART PORT CT. ON OR AROUND (B)(6) 2023, PLAINTIFF WAS TRANSFERRED TO THE OR AT (B)(6) WHERE PLAINTIFF'S SMART PORT CT WAS THEN REMOVED BY (B)(6), PA-C. AFTER REMOVAL OF THE DEFECTIVE SMART PORT CT PORT-A-CATH, PLAINTIFF DID NOT HAVE AN OPPORTUNITY TO CONSULT WITH (B)(6), PA-C, ABOUT THE CAUSES OF HIS CATHETER THROMBOSIS. PLAINTIFF KNEW HE HAD A THROMBOSIS, BUT HE DID NOT KNOW HIS THROMBOSIS WAS CAUSED BY THE SMART PORT CT'S DEFECTS AND/OR BY THE DEFENDANTS' C

  Patient problems: Limb Pain; Thrombosis/Thrombus

  MAUDE report 23733331 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT LEFT SUBCLAVIAN VEIN PLACEMENT OF THE ANGIODYNAMICS SMARTPORT PRODUCT WITH MODEL NUMBER H787CT80STPDVI1 AND LOT NUMBER 5712825. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6) HOSPITAL AT (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, PLAINTIFF BEGAN EXPERIENCING FEVER SPIKES AND WAS FOUND TO HAVE POSITIVE BLOOD CULTURES FOR INFECTION FROM HIS IMPLANTED SMARTPORT. SUBSEQUENTLY, ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT THE SUCCESSFUL REMOVAL OF THE SMARTPORT DEVICE. THE SMARTPORT WAS REMOVED BY DR. (B)(6) HOSPITAL AT (B)(6).

  Patient problems: Bacteremia; Bacterial Infection; Fever

  MAUDE report 23576987 ↗
• InjuryNov 17, 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 5645796. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD, AT (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL IN (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23576516 ↗
• MalfunctionNov 3, 2025Fracture; No Flow; Fracture; No Flow

  ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER H787CT80STPDVI1, LOT NUMBER 5751564. THE DEVICE WAS IMPLANTED BY (B)(6) FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S PORT SITE WAS PAINFUL, AND PORT WAS NON-FUNCTIONAL. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2023. PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6). UPON REMOVAL, A LINEAR HOLE WAS DISCOVERED IN THE TERMINAL POTION OF THE PORT TUBING.

  Patient problems: Implant Pain

  MAUDE report 23452416 ↗
• InjuryOct 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 SMARTPORT, REFERENCE NUMBER (B)(4) LOT NUMBER A2223005. THE DEVICE WAS IMPLANTED BY (B)(6) FOR THE PURPOSE OF ONGOING VEIN ACCESS FOR CHEMOTHERAPY TO TREAT PLAINTIFF'S CECAL COLON CANCER. ON OR ABOUT (B)(6) 2023, THE PLAINTIFF BEGAN EXPERIENCING PAIN AND SWELLING IN HIS RIGHT NECK. BASED ON THESE SYMPTOMS, PLAINTIFF'S TREATING PROVIDERS ORDERED AN ULTRASOUND OF HIS RIGHT UPPER EXTREMITY VEINS. PLAINTIFF UNDERWENT AN ULTRASOUND ON (B)(6) 2023 AT (B)(6), WHICH REVEALED ACUTE DEEP VEIN THROMBOSIS (DVT) IN HIS RIGHT UPPER EXTREMITY ALONG THE INTERNAL JUGULAR VEIN. PLAINTIFF WAS SUBSEQUENTLY DIAGNOSED WITH ACUTE DEEP VEIN THROMBOSIS (DVT) OF THE RIGHT INTERNAL JUGULAR VEIN AND PRESCRIBED ELIQUIS (APIXABAN), WHICH HE BEGAN TAKING ON (B)(6) 2023. PLAINTIFF CONTINUED TO TAKE ELIQUIS TO TREAT HIS ACUTE DEEP VEIN THROMBOSIS (DVT) FOR 20 WEEKS, UNTIL (B)(6)2024 WHEN HE WAS INSTRUCTED BY HIS PHYSICIAN TO STOP TAKING.

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

  MAUDE report 23388017 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062414. One submission often covers many models, so check the product and lot details in each record.

• Z-1466-2021 · Feb 22, 2021 · Terminated
  Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of me
• Z-0056-2012 · Aug 1, 2011 · Terminated
  8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyur