Smart Port CT H787CT80STPD0Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 15051684018036), received between Mar 10, 2025 and Sep 28, 2026 — classified as 2 deaths, 30 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fracture; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923679 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2018, Plaintiff under placement of an Angiodynamics SmartPort Injectable port catheter device, with model number H787CT80STPD0, and lot number 5072844. The device was implanted by Dr. (b)(6) at (b)(6) Hospital, Ohio for chemotherapy administration to treat Plaintiff's cancer.On or about (b)(6), 2018, Plaintiff presented to the (b)(6) Hospital, Ohio for removal of the port catheter and a preoperative CT scan, she was suffering from shortness of breath.On or about (b)(6), 2018, Plaintiff's defective port was removed by Dr. (b)(6), (b)(6) Hospital, Ohio.

  Patient problems: Dyspnea

  MAUDE report 50201619 ↗
• DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2021, Decedent Plaintiff underwent placement of an AngioDynamics SmartPort product, reference number (b)(4), and lot number 5676112. The device was implanted by Dr. (b)(6), MD and (b)(6), MD at (b)(6) for the purpose of providing chemotherapy.On or about (b)(6) 2023, Decedent Plaintiff was diagnosed with an infection.On or about (b)(6) 2023, Decedent Plaintiff presented back to the hospital and was diagnosed with severe neutropenia.On (b)(6) 2023, Decedent Plaintiff passed away due to complications from the direct and proximate effects of his port infections.

  Patient problems: Low White Blood Cell Count; Unspecified Infection

  MAUDE report 50201604 ↗
• MalfunctionAug 11, 2026Difficult to Flush; No Flow

  On or about(b)(6) 2014, Plaintiff underwent placement of an AngioDynamics SmartPort port catheter product, model number CT80STPD, lot number 475663. The SmartPort was implanted on the right side of her chest by Dr. Summer Thomas, MD, at Unity Healthcare in Lafayette, IN.On or about (b)(6), 2015, plaintiff presented to Franciscan Health in Lafayette East after experiencing continued complications and pain associated with the use of her implanted SmartPort during chemotherapy treatment. When medical staff attempted to administer chemotherapy through the SmartPort, they were unable to obtain blood return or properly flush the device, both of which are recognized signs of an occluded implanted venous access port. The SmartPort was surgically removed from the plaintiff's body on (b)(6), 2015.

  Patient problems: Implant Pain

  MAUDE report 50201602 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2025, Plaintiff underwent placement of an AngioDynamics SmartPort port catheter product, with model number H787CT80STPD0, and lot number A0225043. This SmartPort device consisted of a port body and a polyurethane catheter.The SmartPort device was implanted by Dr. (b)(6), at (b)(6) Medical Center in (b)(6), for the purpose of ongoing chemotherapy treatment.On (b)(6) 2026, Plaintiff presented to (b)(6) Hospital in (b)(6), with complaints of a persistent fever and edema of the right arm. Blood cultures were drawn from the SmartPort and came back positive for sepsis. Imaging demonstrated a partially occluded thrombus at the junction of the right internal jugular and subclavian vein.

  Patient problems: Fever; Sepsis; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 50201599 ↗
• InjuryJul 29, 2026Failure to Infuse

  On or about (b)(6) 2024, Plaintiff required surgery under general anesthesia because the left port-a-cath device placed on (b)(6) 2024 had thrombosis and was non-functioning. Dr. (b)(6) performed surgery at (b)(6) Medical Center. He removed the left side port-a-cath and he placed another right internal jugular port-a-cath device, specifically the AngioDynamics SmartPort CT device, Catalog Number H787CT80STPD0.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50070524 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2015, Plaintiff underwent placement of an Angiodynamics SmartPort CT device, Catalog Number H787CT80STPD0; Lot Number 4873601. The device was implanted by (b)(6), DO at (b)(6) Medical Center in (b)(6), for the purpose of ongoing vein access for medication to treat plaintiff's Loin Pain-Hematuria Syndrome. The device was placed in Plaintiff's right-sided internal jugular vein and right-side anterior chest wall.On or about (b)(6) 2015, the Plaintiff was admitted to (b)(6) Medical Center in (b)(6), for evaluation and treatment of central venous catheter infection and bacteremia. Her line cultures and blood cultures were positive for both gram-negatives rods and cocci. Her treating physicians decided to remove the port-catheter device, which was performed on (b)(6) 2015 by (b)(6) DO. Plaintiff remained inpatient until (b)(6) 2015, and she was treated with seven (7) days of intravenous antibiotics during her hospital stay. She was discharged with another seven (7) day course of oral antibiotics.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 50064007 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2019, PLAINTIFF (B)(6) UNDERWENT AN INSERTION OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT80STSD, LOT NUMBER 5433492. UPON INFORMATION AND BELIEF, THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED AT UNIVERSITY HOSPITAL IN COLUMBIA, MISSOURI. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) CANCER CENTER FOR A ROUTINE FOLLOW UP VISIT. PLAINTIFF UNDERWENT A CT OF THE CHEST, ABDOMEN AND PELVIS WITH CONTRAST THAT SHOWED AN INTERVAL DISRUPTION OF A PREVIOUS INTACT LEFT SUBCLAVIAN PORT-A-CATH WITH A BROKEN PORTION OF THE CATHETER WITHIN THE LEFT BRACHIOCEPHALIC VEIN AND SVC. SHE WAS THEN SCHEDULED TO UNDERGO A FOREIGN BODY RETRIEVAL PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2021, AT (B)(6) CANCER CENTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 25484177 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6), 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), AND LOT NUMBER 5668331. THE DEVICE WAS IMPLANTED BY (B)(6) MD AT (B)(6), MISSOURI FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6), 2021, PLAINTIFF WAS DIAGNOSED WITH AN INFECTION, AND PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6), 2021, PLAINTIFF'S INFECTED PORT WAS REMOVED BY DR. (B)(6), DO AT (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 25465813 ↗
• DeathApr 26, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2025, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER: H787CT80STPDO, LOT NUMBER: CT80STPD. THE SMARTPORT WAS IMPLANTED ON THE RIGHT SIDE OF HIS CHEST BY DR. (B)(6), MD, AT (B)(6). IN OR ABOUT ON (B)(6) 2025, DECEDENT PRESENT TO THE (B)(6), IN (B)(6), WITH SWELLING AND PAIN IN HIS RIGHT CHEST AS WELL AS SIGNIFICANT AXILLARY TENDERNESS. HIS MEDICAL TEAM DETERMINED THAT HE HAD AN INFECTION AND THE SOURCE WAS HIS PORT CATHETER. THE DEFECTIVE PORT WAS SUBSEQUENTLY REMOVED ON (B)(6) 2025. DECEDENT PASSED ON (B)(6) 2025.

  Patient problems: Chest Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24993613 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT PLACEMENT OF A SMARTPORT CT POWER INJECTABLE PORT, WITH MODEL NUMBER H787CT80STPD0 AND LOT NUMBER 5449490. THE DEVICE WAS IMPLANTED BY DR. (B)(6), AT (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING INTRAVENOUS ACCESS. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF FEVER AND CHILLS. PLAINTIFF UNDERWENT BLOOD CULTURES, WHICH WERE POSITIVE FOR AN INFECTION. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE PORT NEEDED TO BE REMOVED. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT REMOVAL OF THE SMARTPORT DEVICE. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), AT (B)(6).

  Patient problems: Bacterial Infection; Chills; Fever

  MAUDE report 24731872 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2009, PLAINTIFF UNDERWENT LEFT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT SINGLE TITANIUM PORT SYSTEM WITH VORTEX TECHNOLOGY; CATALOG NUMBER CT80STPD, AND LOT NUMBER 971845. THIS SMARTPORT DEVICE IS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS PRESCRIBED FOR HIS CHEMOTHERAPY DELIVERY TREATMENT BY PHYSICIAN (B)(6) AT THE (B)(6) CANCER SPECIALISTS AND IMPLANTED BY PHYSICIAN (B)(6), M.D., AT (B)(6). ON OR ABOUT (B)(6) 2024, UNDER HOSPITALIZATION BY BACTEREMIA. SUSPECTED OF PORT-A-CATH INFECTION. IT WAS RECOMMENDED BY THE PLAN, THE PORT REMOVAL DUE TO THE PRESENCE, OF A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), IN THE SETTING OF BACTEREMIA TO MITIGATE THE RISK OF PROSTHETIC AORTIC VALVE INFECTION. DIAGNOSIS WAS MADE BY DR. (B)(6) ON THE VISIT. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED AN INFECTIOUS DISEASE, AS THE PHYSICIAN (B)(6), MD DOCUMENTED, UNDER A SUSPICIOUS PORT-A-CATH INFECTION, WHICH HAD TO BE HOSPITALIZED ON (B)(6) 2024, THE PLAINTIFF UNDERWENT AN UNSUCCESSFUL SURGICAL REMOVAL OF THE PORT, AS DIRECTED BY THE PLAN AND THE TREATING MEDICAL PROFESSIONALS. THE SURGERY WAS PERFORMED UNDER THE PRESUMPTION THAT

  Patient problems: Bacteremia; Scar Tissue

  MAUDE report 24678120 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2022, PLAINTIFF UNDERWENT RIGHT INTERNAL JUGULAR VEIN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT PORT CATHETER PRODUCT, WITH MODEL NUMBER: CT80STPD, AND LOT NUMBER: 5708020. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), AND THE PURPOSE OF IMPLANTING THE SMARTPORT WAS TO ADMINISTER CHEMOTHERAPY. ON OR ABOUT ON (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF TENDERNESS AROUND THE PORT SITE. PLAINTIFF UNDERWENT BLOOD CULTURES WHICH INCIDENTALLY REVEALED A STAPHYLOCOCCUS AUREUS INFECTION. ON OR ABOUT ON (B)(6) 2022, WHILE STILL HOSPITALIZED AT (B)(6), PLAINTIFF'S DEFECTIVE DEVICE WAS REMOVED. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Bacterial Infection; Implant Pain

  MAUDE report 24671266 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, (B)(6). UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT CT DEVICE, CATALOG#: CT80STPD, LOT#: 5237428. 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 DR. (B)(6), MD, AT (B)(6), FOR THE IVIG THERAPY FOR PLAINTIFF'S AUTOIMMUNE CEREBELLA ATAXIA. ON OR AROUND ON (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH UPPER CHEST PAIN AND PAIN AROUND HER SMARTPORT CT. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT A FURTHER IMAGING WAS NEEDED WHERE IT WAS CONFIRMED THAT PLAINTIFF HAD A THROMBUS IN THE RIGHT SUBCLAVIAN VEIN, WHICH WOULD REQUIRE ANTICOAGULANTS. THE FOLLOWING DAY, ON (B)(6) 2019, PLAINTIFF UNDERWENT CULTURE TESTING WHERE IT WAS DETERMINED THAT PLAINTIFF TESTED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIS AND REQUIRED REMOVAL OF HER SMARTPORT CT. ON OR AROUND ON (B)(6) 2019, (B)(6) DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), MD, AT (B)(6) HOSPITAL, IN (B)(6). AFTER REMOVAL OF THE DEFECTIVE SMARTPORT CT PORT-A-CATH, PLAINTIFF DID NOT HAVE AN OPPORTUNITY TO CONSULT WITH DR. (B)(6), M.D., A

  Patient problems: Bacterial Infection; Chest Pain; Thrombosis/Thrombus

  MAUDE report 24565602 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS 8F SMARTPORT PRODUCT, REFERENCE NUMBER H787CT80STPD0, LOT NUMBER 5743901. THE DEVICE WAS IMPLANTED BY DR. (B)(6). 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 THAT REQUIRED PORT REMOVAL AND REPLACEMENT. FOLLOWING PLAINTIFF'S DIAGNOSIS, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED AT (B)(6) HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 24479673 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2013, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMART PORT IN THE LEFT SUBCLAVIAN, WITH MODEL NUMBER CT80STPD. THE SMART PORT WAS COMPROMISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMART PORT WAS IMPLANTED BY DR.(B)(6), M.D., (B)(6) HOSPITAL, IN (B)(6). ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL, IN (B)(6), FOR REMOVAL OF THE SMART PORT. DURING THE PROCEDURE, DR. (B)(6) WAS UNABLE TO REMOVE THE CATHETER, LEAVING IT RETAINED FROM THE LEFT ANKLE RETICULAR SOFT TISSUES TO THE LEFT BRACHIOCEPHALIC VEIN, PRIOR TO THE MIDLINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24316630 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2022, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, DEVICE IDENTIFICATION NUMBER H787CT80STPD0, AND CATALOGUE NUMBER CT80STPD. THE DEVICE WAS IMPLANTED BY (B)(6) M.D., AT (B)(6) OUTPATIENT SURGERY CENTER (B)(6), TO BE USED FOR CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) CENTER WITH A CHIEF COMPLAINT OF SUSPICION OF HAVING RETAINED CHEST PORT MATERIAL, WHERE SHE WAS DIAGNOSED WITH A RETAINED FRAGMENT OF THE CATHETER IN HER BODY FROM THE PLAINTIFF'S SMARTPORT. ON OR ABOUT (B)(6) 2023, (B)(6), MD REMOVED THE CATHETER FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24298185 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, LOT NUMBER 5686349, REFERENCE NUMBER (B)(4). THE DEVICE WAS IMPLANTED BY (B)(6) AT (B)(6). ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO THROMBOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24202006 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER CT80STPD, AND LOT NUMBER 540894, WHICH WAS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) HOSPITAL AND MEDICAL CENTER IN (B)(6) FOR CHEMOTHERAPY TREATMENT. ON (B)(6) 2011, DECEDENT PRESENTED TO (B)(6) HOSPITAL AND MEDICAL CENTER IN (B)(6) WITH COMPLAINTS OF NECK SWELLING. DECEDENT UNDERWENT A VUS DUPLEX SCAN AND WAS DIAGNOSED WITH OCCLUSIVE THROMBOSIS IN HIS RIGHT INTERNAL JUGULAR VEIN. DECEDENT'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT REQUIRED REMOVAL. ON (B)(6) 2011, DECEDENT UNDERWENT REMOVAL OF THE SMARTPORT, AND THE PROCEDURE WAS PERFORMED BY DR. (B)(6), AT (B)(6) HOSPITAL AND MEDICAL CENTER IN (B)(6).

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24122609 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2025, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT INJECTABLE PORT CATHETER DEVICE, WITH MODEL NUMBER H787CT80STPD0, AND LOT NUMBER A2924001. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6), FOR CHEMOTHERAPY ADMINISTRATION TO TREAT PLAINTIFF'S OVARIAN CANCER. ON OR ABOUT (B)(6) 2025, PLAINTIFF PRESENTED TO (B)(6) MEDICAL SPECIALTIES, EMERGENCY (B)(6), WITH SEPSIS. AFTER INTERVENTIONAL RADIOLOGY CONSULTATION, THE MEDICAL PROVIDERS DEEMED THE PORT NEEDED TO BE REMOVED. ON OR ABOUT (B)(6) 2025, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) MEDICAL SPECIALTIES IN (B)(6).

  Patient problems: Sepsis

  MAUDE report 23882881 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5704810. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6) FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2024, PLAINTIFF'S PORT WAS NON-FUNCTIONAL AND NOTED TO BE FRACTURED. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2024, CATHETER FRAGMENT RETRIEVAL WAS ATTEMPTED BY DR. (B)(6), MD AT (B)(6), BUT ATTEMPT WAS UNSUCCESSFUL. ON OR ABOUT (B)(6) 2024, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6), CHEST X-RAY SHOWED RETAINED PIECE OF THE CATHETER GOING FROM THE LEFT HEART TO THE RIGHT, FRAGMENT REMOVAL ATTEMPT WAS AGAIN UNSUCCESSFUL. ON OR ABOUT (B)(6) 2024, THE RETAINED CATHETER FRAGMENT WAS SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882790 ↗
• 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 AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER H787CT80STPD0, LOT NUMBER 5803622. THE DEVICE WAS IMPLANTED BY DR. (B)(6) MD AT (B)(6) HOSPITAL IN (B)(6) FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF WAS DIAGNOSED WITH AN INFECTION. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 23830784 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO ON (B)(6) 2020, PLAINTIFF WAS DIAGNOSED WITH CANCER. THE TREATMENT FOR PLAINTIFF'S CANCER INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HER RIGHT UPPER CHEST. ON OR ABOUT ON (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING ANGIODYNAMICS' PORT INF CT TITANIUM 8FR, INVENTORY ITEM: PORT INF CT TITANIUM 8FR IMPLANT NAME: PORT INF CT TITANIUM 8FR - LOG280066 MODEL/CAT NO.: H787CT80STPDO, MANUFACTURER: ANGIODYNAMICS, FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY. ON OR ABOUT ON (B)(6) 2020, THE DEVICE AT ISSUE WAS IMPLANTED BY (B)(6), MD AT (B)(6) CENTER IN (B)(6) FOR THE PURPOSES INDICATED ABOVE. THE DEFENDANTS, DIRECTLY OR THROUGH THEIR AGENTS, APPARENT AGENTS, SERVANTS, OR EMPLOYEES, DESIGNED, MANUFACTURED, MARKETED, ADVERTISED, DISTRIBUTED, AND SOLD THE PORT INF CT TITANIUM 8FR THAT WAS IMPLANTED IN (B)(6). UPON INFORMATION AND BELIEF, ON (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6) CENTER IN (B)(6) WHERE PLAINTIFF WAS SEEN FOR AN EXTREMELY HIGH FEVER AND EVIDENCE OF SEPSIS. ON OR ABOUT APRIL, PLAINTIFF WAS ALSO TREATED FOR A SUSPECTED INFECTION AT THE PORT SITE WITH ANTIBIOTICS

  Patient problems: Bacterial Infection; Fever; Medical device site infection; Sepsis

  MAUDE report 23830615 ↗
• MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT AN END USER EXPERIENCED AN ISSUE WITH A SINGLE TITANIUM CT VTX PORT W POLY CATH. APPROXIMATELY 9 DAYS POST PORT REMOVAL, THE PATIENT UNDERWENT ROUTINE CT AND PET IMAGING, AT WHICH TIME IT WAS DISCOVERED THAT THE CUFF FROM THE PORT DEVICE HAD BEEN RETAINED. AT THE TIME OF THE PORTACATH REMOVAL IN THE IR DEPARTMENT, POST FLOURO IMAGES HAD BEEN TAKEN, WHICH DID NOT SHOW THE CUFF. THE PATIENT HAS BEEN SCHEDULED FOR REMOVAL OF THE CUFF AND EDUCATION HAS BEEN PROVIDED FOR THE PROCEDURIST TO ENSURE THAT ALL 3 PIECES OF THE PORT DEVICE ARE REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777849 ↗
• MalfunctionDec 8, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER CT80STPD, AND LOT NUMBER 5712828. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6) AT MEDICAL CENTER, (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT A CHEST X-RAY DURING PRE-OP TESTING WHICH REVEALED THAT PLAINTIFF'S SMARTPORT WAS FRACTURED WITH THE FRACTURE FRAGMENT EXTENDING FROM THE RIGHT ATRIUM TO THE ORIGIN OF THE CORONARY SINUS. ON (B)(6) 2024 PLAINTIFF UNDERWENT REMOVAL OF THE SMARTPORT AT (B)(6) "MEDICAL" CENTER (B)(6). THE PROCEDURE WAS PERFORMED BY DR. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23737106 ↗

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