Smart Port CT CT80STPARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787CT80STPA0), received between Feb 10, 2023 and Sep 7, 2023 — classified as 2 injuries, 1 malfunction.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Fracture; Fracture

  AN ANGIODYNAMICS REGIONAL BUSINESS MANAGER REPORTED AN ISSUE WITH A SMARTPORT CT VTX SLTIT 8 ATT POLY CATHETER. AFTER THE PHYSICIAN REMOVED THE PATIENT'S PORT, IT WAS NOTED THAT THERE WAS ONLY AN INCH OF CATHETER ATTACHED AND THE REST HAS SHEARED OFF AND WAS RETAINED IN THE PATIENT. THE PHYSICIAN WAS UNABLE TO SEE THE RETAINED TUBING; THEREFORE, THE PATIENT HAD A CHEST X-RAY PERFORMED AND WAS REFERRED TO "FGH" FOR A PERCUTANEOUS RETRIEVAL BY A RADIOLOGIST. THE RADIOLOGIST FELT THAT ATTEMPTING TO REMOVE THE FRAGMENT WOULD BE MORE DETRIMENTAL TO THE PATIENT, RATHER THAN LEAVING IT IN SITU. THE RADIOLOGIST REPORTED THAT THE FRAGMENT WAS "WALLED OFF" AND WILL NOT CAUSE HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 17699541 ↗
• InjuryFeb 28, 2023Fracture; Fracture

  A PATIENT'S SMARTPORT WAS REMOVED DUE TO DIFFICULTY FLUSHING AND DRAWING FOR SOME TIME AS REPORTED BY THE PATIENT. AN INCISION WAS MADE OVER THE OLD PORT. THE ADHESIONS WERE DISSECTED OFF AND THE PORT FREED. THE LINE WAS GROWN IN AND THE PROVIDER WAS ABLE TO GENTLY MANIPULATE THE LINE TO GET THE FIRST FEW CENTIMETERS OUT. WHEN THE PORT WAS REMOVED, IT WAS NOTICED THE CATHETER HAD DETACHED AND THE REMAINING END STILL ATTACHED TO THE PORT STEM WAS DAMAGED AND TORN. IT WAS FOUND THAT THE DISTAL END OF THE CATHETER HAD MIGRATED TO THE HEART. THE PATIENT WAS BEING TRANSPORTED TO ANOTHER FACILITY FOR REMOVAL. IT WAS REPORTED THAT AT THE TIME OF PLACEMENT, IMAGES WERE TAKEN SHOWING THE PORT AND CATHETER WERE INTACT AND CORRECTLY PLACED. THE PORT IN QUESTION WAS PLACED IN THE RIGHT SUBCLAVIAN. THE NEW PORT WAS PLACED IN THE LEFT SUBCLAVIAN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16453060 ↗
• InjuryFeb 10, 2023Break; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2023 1:10 PM BY RISK, RDE - THIS PATIENT ENTERED THE OR (OPERATING ROOM) FOR PORT REMOVAL AND INSERTION OF A NEW PORT-A-CATH. UPON REMOVAL OF THE EXISTING PORT, PORT WAS INTACT AND CATHETER TIP WAS TORN UPON EXAMINATION. PORT AND CATHETER SAVED. PATIENT WAS TRANSFERRED TO AMARILLO FOR REMOVAL OF BROKEN PIECE.

  Patient problems: Insufficient Information

  MAUDE report 16364341 ↗

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