Smart Port CT H787CT80STPDNF0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15051684018043), received between Sep 15, 2025 and Sep 24, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 port catheter product, with model number H787CT80STPDNF0.The Smart Port device was implanted by Dr. (b)(6), at (b)(6) in (b)(6), for the principal purpose of medication administration for Plaintiff's Crohn's disease.On or about (b)(6) 2024, Plaintiff presented to Dr. (b)(6) at (b)(6) who diagnosed the Plaintiff with bacteremia.On or about (b)(6) 2024, Plaintiff presented to (b)(6) at (b)(6) to have the Smart Port removed due to the Plaintiff's infection.

  Patient problems: Bacteremia

  MAUDE report 50876706 ↗
• MalfunctionDec 13, 2025Fracture; Fracture

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT CATHETER PRODUCT, WITH MODEL NUMBER H787CT80STPDNF0, AND LOT NUMBER 5727278. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6) AT (B)(6) FOR THE PURPOSE OF ONGOING MYASTHENIA GRAVIS. ON OR ABOUT (B)(6) 2024, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF CHEST PAIN. SUBSEQUENTLY, PLAINTIFF UNDERWENT AN MRI WHICH REVEALED A FRACTURED SMARTPORT CATHETER. ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT REMOVAL OF THE SMARTPORT RESERVOIR AND CATHETER FRAGMENTS AT (B)(6). THE PROCEDURE WAS PERFORMED BY DR. (B)(6).

  Patient problems: Chest Pain

  MAUDE report 23797711 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER CT80STPD-NF, AND LOT NUMBER 4987769. THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND POLYURETHANE CATHETER. THE DEVICE WAS IMPLANTED BY DR.(B)(6), M.D, (B)(6), FOR ADMINISTRATION OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF FEVERS AND CHILLS. BLOOD CULTURES WERE DRAWN FROM PLAINTIFF'S SMARTPORT, WHICH CAME BACK POSITIVE FOR SERRATIA MARCESCENS. PLAINTIFF WAS TREATED WITH MEDICATION. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF A FEVER. BLOOD CULTURES WERE DRAWN AND CAME BACK POSITIVE FOR SERRATIA MARCESCENS. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WOULD NEED TO BE REMOVED. ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE SMARTPORT, AND THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D (B)(6).

  Patient problems: Bacterial Infection; Chills; Fever

  MAUDE report 23053789 ↗

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