Smart Port CT H787CT80STPAVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684018142), received between Sep 17, 2025 and Sep 17, 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.

• DeathSep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2023, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER: H787CT80STPAVI1, AND LOT NUMBER: 5766912. THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), AND THE PURPOSE OF IMPLANTATION OF THE SMARTPORT WAS TO ADMINISTER MEDICATION TO TREAT DECEDENT'S ESOPHAGEAL CANCER. ON OR ABOUT ON (B)(6) 2023, DECEDENT PRESENTED TO (B)(6), WITH COMPLAINTS OF NECK AND LEG PAIN. DECEDENT'S BLOOD WAS DRAWN FROM THE SMARTPORT AND WAS SUBSEQUENTLY CULTURED, REVEALING THAT DECEDENT WAS SUFFERING FROM BACTEREMIA, AND THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION. THE INFECTION QUICKLY PROGRESSED INTO SEVERE SEPSIS. ON OR ABOUT ON (B)(6) 2023, WHILE STILL HOSPITALIZED AT (B)(6), DECEDENT UNDERWENT REMOVAL OF THE INFECTED SMARTPORT. THIS REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. DESPITE REMOVAL OF THE INFECTED SMARTPORT AND TREATMENT FOR THE SEVERE SEPSIS AFTER REMOVAL OF THE DEVICE, DECEDENT CONTINUED TO HAVE A FEVER AND OTHER SYMPTOMS SUGGESTIVE OF AN ONGOING INFECTION, REMAINING HOSPITALIZED AT (B)(6) TO UNDERGO CONTINUED TR

  Patient problems: Bacteremia; Embolism/Embolus; Fever; Limb Pain; Neck Pain; Sepsis

  MAUDE report 23080307 ↗

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