Smart Port CT H787CT96STSAVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684018173), received between Nov 3, 2025 and Nov 3, 2025 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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), LOT NUMBER 5665259. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6) FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, DECEDENT PLAINTIFF'S PORT WAS FOUND TO BE INFECTED, AND DECEDENT PLAINTIFF WAS DIAGNOSED WITH SEPSIS CAUSED BY ENTEROCOCCUS FAECALIS, BUT WAS SUBSEQUENTLY DISCHARGED. ON OR ABOUT (B)(6), 2023, DECEDENT PLAINTIFF WAS ADMITTED INTO THE INTENSIVE CARE UNIT AND WAS DIAGNOSED WITH SEVERE SEPSIS WITH SEPTIC SHOCK. ON OR ABOUT (B)(6) 2023, DECEDENT PLAINTIFF PRESENTED BACK TO THE HOSPITAL WITH CHILLS AND WAS DIAGNOSED WITH SEVERE SEPSIS. ON OR ABOUT (B)(6), 2023, DECEDENT PLAINTIFF PRESENTED BACK TO THE HOSPITAL AND WAS DIAGNOSED WITH PSEUDOMONAS AERUGINOSA AND CITROBACTER FREUNDII COMPLEX. AFTER AN INFECTIOUS DISEASE CONSULTATION, IT WAS DETERMINED THAT THE SOURCE OF HER INFECTIONS WAS FROM HER PORT. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6), 2023, DECEDENT PLAINTIFF'S PORT WAS REMOVED BY DR. (B)(6). ON OR ABOUT (B)(6), 2023, DECEDENT PLAINTIFF WAS TAKEN TO THE HOSPITAL VIA AMBULANCE DUE TO UNRESPONSIVENESS. PLAINTIF

  Patient problems: Apnea; Bacterial Infection; Decreased Level of Consciousness; Drug Resistant Bacterial Infection; Sepsis; Septic Shock

  MAUDE report 23455987 ↗

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