Smart Port CT H787CT96STSDNF0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15051684018074), received between Mar 12, 2025 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT, MODEL NUMBER CT96STSD-NF, LOT NUMBER 4820412. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), AT (B)(6). ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF LEG PAIN AND A PAIN CRISIS. SHE UNDERWENT BLOOD CULTURES AFTER EXHIBITING SYMPTOMS OF INFECTION. THE BLOOD CULTURES GREW SERRATIA. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT IT REQUIRED REMOVAL. ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT AN UNSUCCESSFUL ATTEMPT TO REMOVE THE SMARTPORT BY DR. (B)(6) THE PORT WAS SCARRED IN PLACE, AND DR. (B)(6) WAS UNABLE TO REMOVE THE DEVICE. ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT AN ADDITIONAL PROCEDURE TO HAVE THE SMARTPORT REMOVED. THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), AT (B)(6).

  Patient problems: Bacterial Infection; Limb Pain; Pain

  MAUDE report 24728320 ↗
• MalfunctionMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A CT VTX PORT W/SIL CATH NONFILLED HOLES. A PATIENT PRESENTED TO AN INFUSION CLINIC FOR THEIR FIRST INFUSION, POST IMPLANTATION. WHILE THE LINE WAS BEING FLUSHED WITH SALINE, THE PATIENT IMMEDIATELY COMPLAINED OF PAIN. THE PROCEDURE WAS STOPPED AND PATIENT RECEIVED A CONSULTATION WITH A PHYSICIAN. THE PHYSICIAN DETERMINED THAT AN EMERGENCY EXTRACTION OF THE DEVICE NEEDED TO TAKE PLACE; THEREFORE, THE PORT WAS REMOVED AND REPLACED WITH A PICC LINE. UPON INSPECTION, IT APPEARED THAT THE LINE DISCONNECTED FROM THE DEVICE, INSIDE THE STRAIN RELIEF, THAT IS LOCATED BELOW THE PORT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586639 ↗

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