Smart Port CT H787CT80STPDNFVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15051684018159), received between Dec 4, 2025 and Dec 4, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Fracture; Fracture

  PRIOR TO (B)(6) 2020, THE PLAINTIFF HAD CERTAIN MEDICAL CONDITIONS, AND HER PHYSICIANS HAD A PORT CATHETER PLACED IN HER. UPON INFORMATION AND BELIEF, THE PLAINTIFF HAD A PORT CATHETER MANUFACTURED BY THE DEFENDANTS PLACED IN HER. ON (B)(6) 2020, THE PLAINTIFF WAS TAKEN TO SURGERY AT A FACILITY, (B)(6), FOR REMOVAL OF THE PORT CATHETER WHICH HAD BEEN PLACED INSIDE THE LEFT SIDE OF HER CHEST AS THE PORT CATHETER HAD MALFUNCTIONED, WHICH MALFUNCTION, UPON INFORMATION AND BELIEF AND PER THE MEDICAL RECORDS, INCLUDED A "CRACK IN TUBING" AND SHE UNDERWENT PLACEMENT OF A NEW PORT CATHETER, MANUFACTURED BY ANGIODYNAMICS, KNOWN AS A SMART PORT, AND IDENTIFIED IN THE MEDICAL RECORD AS UPN H787CT80STPDNFVII, LOT NO.: 5590939, MANUFACTURER: ANGIODYNAMICS, FOR THE PURPOSES OF PLAINTIFF'S MEDICAL TREATMENT. THEREAFTER, THE PLAINTIFF UNDERWENT FURTHER SURGERY AT (B)(6) FACILITY IN (B)(6), ON (B)(6) 2021, AS THE DEVICE PLACED INSIDE HER ON (B)(6) 2020, WAS FOUND ON TESTING TO BE MALFUNCTIONING IN THAT THERE WAS EXTRAVASATION FROM THE CATHETER, SO THE ANGIODYNAMICS PORT CATHETER WAS REMOVED AND A NEW PORT CATHETER PLACED INSIDE OF HER. DURING THE SURGERY OF (B)(6) 2021, THE SURGEON NOTED IN THE OP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717201 ↗

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