Smart Port CT H787CT80STPA0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15051684018029), received between Aug 30, 2024 and Sep 15, 2025 — classified as 2 injuries.

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.

• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT LEFT SUBCLAVIAN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER DEVICE, WITH MODEL NUMBER H787CT80STPA0, AND LOT NUMBER 5460181. THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THIS SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) IN (B)(6), AND THE PURPOSE OF IMPLANTATION OF THE SMARTPORT WAS TO ADMINISTER MEDICATION TO TREAT PLAINTIFF'S (B)(6) DISEASE. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6) IN (B)(6), WITH COMPLAINTS OF WEAKNESS, SHORTNESS OF BREATH, DEHYDRATION, NAUSEA, VOMITING, AND POOR ORAL INTAKE. PLAINTIFF SUBSEQUENTLY UNDERWENT LAB WORK AND BLOOD CULTURES, WHICH REVEALED HER SMARTPORT DEVICE WAS INFECTED, AND WOULD NEED TO BE REMOVED. ON OR ABOUT (B)(6) 2019, WHILE STILL HOSPITALIZED AT (B)(6) IN (B)(6), PLAINTIFF UNDERWENT REMOVAL OF THE INFECTED SMARTPORT DEVICE, AND THE PROCEDURE WAS PERFORMED BY DR. (B)(6) M.D.

  Patient problems: Decreased Appetite; Dehydration; Diarrhea; Dyspnea; Muscle Weakness/Atrophy; Unspecified Infection; Vomiting

  MAUDE report 23052079 ↗
• InjuryAug 30, 2024Detachment of Device or Device Component; Infusion or Flow Problem; Detachment of Device or Device Component; Infusion or Flow Problem

  ON (B)(6) 2021, PLAINTIFF HAD A SMART PORT PLACED IN HER RIGHT CHEST AREA TO FACILITATE PERIODIC VENOUS INFUSIONS FOR RHEUMATOID ARTHRITIS. BY (B)(6) 2023, PLAINTIFF'S PROVIDERS BEGAN EXPERIENCING DIFFICULTIES ADMINISTERING INFUSIONS; THEREFORE, IT WAS RECOMMENDED BY THE PHYSICIAN TO HAVE A NEW PORT-A-CATH PLACED, IN A DIFFERENT ANATOMICAL LOCATION. IN PREPARATION FOR PLACEMENT OF THE NEW PORT AND REMOVAL OF THE SMART PORT, PLAINTIFF WAS GIVEN AN X-RAY ON (B)(6) 2023, WHICH WAS READ BY DEFENDANT DR. BURSZYTN. THE DEFENDANT FAILED TO NOTICE THAT THE PORT "[CATHETER TUBING]" WAS FRACTURED. ON (B)(6) 2023, THE PLAINTIFF UNDERWENT A SURGICAL PROCEDURE WHEREIN THE SURGEON PLACED A NEW PORT-A-CATH ON THE LEFT SIDE OF THE CHEST AND THEN BEGAN TO REMOVE THE PORT THAT WAS PREVIOUSLY IMPLANTED IN THE RIGHT SIDE OF THE PLAINTIFF'S CHEST. WHEN THE PHYSICIAN REMOVED THE PORT, IT WAS THEN NOTICED TO BE FRACTURED, WITH A JAGGED EDGE, AND APPROXIMATELY 2/3 OF THE "[CATHETER TUBING]" DEVICE WAS MISSING. A CT SCAN LATER REVEALED THAT THE MISSING PART OF THE PORT "[DISTAL PORTION OF CATHETER TUBING]" WAS IN THE PLAINTIFF'S VENOUS SYSTEM; THEREFORE, SHE WAS TRANSFERRED TO A MEDICAL FACILITY IN AMARILL

  Patient problems: Foreign Body In Patient

  MAUDE report 20107004 ↗

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