Smart Port CT CT80STPD-NFVIRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787CT80STPDNFVI1), received between Feb 12, 2020 and Jul 18, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED DEVELOPING AN INFECTION OF THEIR CT W/NF 8FR DETACHED POLY CATH VI SMARTPORT, RESULTING IN PORT REMOVAL. THE INFECTION WAS TREATED WITH MEDICATION. NO FURTHER DETAILS HAVE BEEN PROVIDED DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection

  MAUDE report 19776214 ↗
• MalfunctionMay 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A CT W/NF 8FR DET POLY CATH VI SMARTPORT. THE PORT WAS BEING REMOVED DUE TO IT NOT FUNCTIONING AS INTENDED (NO DETAILS PROVIDED). DURING PORT REMOVAL, THE SURGEON NOTICED THE SMARTPORT CONNECTOR (BLUE BOOT STRAIN RELIEF) SLIPPED OFF. THERE WAS NO INDICATION THE BLUE BOOT WAS RETAINED INSIDE THE PATIENT. THE PORT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A BARD DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900364 ↗
• MalfunctionMar 19, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A SMARTPORT CT. DURING REMOVAL OF A POORLY FUNCTIONING PORT, A CRACK/SPLIT IN THE CATHETER WAS DISCOVERED. THE CATHETER ON THE PORT WAS SPLIT AT THE 14 CM MARK. PORT FAILED AND NEEDED REPLACED. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528410 ↗
• MalfunctionMar 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AN END USER REPORTED AN ISSUE WITH A SMARTPORT CT. DURING REMOVAL OF A POORLY FUNCTIONING PORT, A CRACK/SPLIT IN THE CATHETER WAS DISCOVERED. A NEW PORT WAS PLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429681 ↗
• MalfunctionFeb 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AN END USER REPORTED AN ISSUE WITH A SMARTPORT CT. POST PROCEDURE, THE PORT WAS NOT PERFORMING WELL; THEREFORE, A SCAN WAS CONDUCTED, UNDER FLURO, AND A CRACK WAS DISCOVERED "BETWEEN 13 AND 14." THE PORT WAS REMOVED AND REPLACED WITH ANOTHER SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258904 ↗
• MalfunctionFeb 12, 2020Fracture; Fracture

  COMPLAINT WAS FILED VIA ANGIODYNAMICS' ETHICS HOTLINE, CASE #34: (B)(6) WAS INFORMED BY (B)(6), RN FIRST ASSIST, ABOUT A PORT THAT WAS MANUFACTURED BY ANGIODYNAMICS, INC. AND THAT TORE IN HALF. THE PORT WAS PLACED IN THE PATIENT DURING SURGERY AT (B)(6) ON (B)(6) 2019, BUT IT IS UNKNOWN WHEN THE PORT WAS TORN. IT WAS NOT TORN DURING THE INSERTION OF THE PORT, BUT POSSIBLY LATER ON DURING TREATMENT. IT WAS REPORTED THAT DOCTORS WERE GIVING THE PATIENT TREATMENT WHEN THEY HEARD A POP AND SAW THAT THE PORT HAD TORN IN HALF. THE PORT'S LOT NUMBER IS 5418429 AND THE CATEGORY IS CT80STPD-NFVI1. (B)(6) WISHES TO DOCUMENT THIS ISSUE WITH THE COMPANY. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700657 ↗

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