Smart Port CT CT96STSD-NFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787CT96STSDNF0), received between Jul 7, 2022 and Jul 7, 2022 — 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 16, 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.

• MalfunctionJul 7, 2022Fracture; Fracture

  A DISTRIBUTOR REPORTED A PHYSICIAN EXPERIENCED AN ISSUE WITH A SMARTPORT, CT VTX PORT W/SIL CATH NON-FILLED HOLES. APPROXIMATELY TWO YEARS AGO, A 60-YEAR-OLD FEMALE PATIENT WAS IMPLANTED WITH A SMARTPORT RESERVOIR CATHETER, RIGHT SUBCLAVIAN ROUTE WITHOUT INCIDENT. IT WAS NOTED THE CATHETER HAD PARTIALLY "RUPTURED" THREE DAYS PRIOR TO REPORTING THE EVENT TO ANGIODYNAMICS. DUE TO THIS ISSUE, IT WAS DETERMINED TO REMOVE THE PORT DEVICE. DURING THE INITIAL ATTEMPT TO REMOVE THE PORT CATHETER, APPROXIMATELY HALF OF THE DISTAL CATHETER DETACHED, MIGRATING TO THE ATRIUM. IT WAS EXTRACTED BY RIGHT FEMORAL VENOUS APPROACH, WITH A 12F INTRODUCER. THE PROVIDER ADVANCED THE CATHETER TO THE RIGHT ATRIUM, WHERE THE PROXIMAL END OF THE FRACTURED CATHETER IS LOCATED. THE PROVIDER WAS ABLE TO CATCH THIS FRAGMENT WITH A BOW, WITH WHICH THEY MANAGED TO INTRODUCE IT. REMOVAL OF THE FRAGMENT WAS SUCCESSFUL WITHOUT INCIDENT. CLOSURE OF PUNCTURE SITE BY MANUAL COMPRESSION WAS PERFORMED FOR 15 MINUTES AND COMPRESSIVE BANDAGE APPLIED ACCORDING TO PROTOCOL. IT WAS REPORTED THE PATIENT IS DOING WELL. .

  Patient problems: Foreign Body In Patient

  MAUDE report 14944720 ↗

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