Smart Port CT CT80STPD-NFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787CT80STPDNF0), received between Aug 17, 2022 and Aug 17, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (6 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.

• MalfunctionAug 17, 2022Migration or Expulsion of Device; Infusion or Flow Problem; Migration or Expulsion of Device; Infusion or Flow Problem

  IT WAS REPORTED THERE WAS NO BLOOD RETURN DURING TWO TREATMENT SESSIONS IN WHICH CATHFLO WAS USED IN ORDER TO OBTAIN A BLOOD RETURN. THE PATIENT HAD A PORTOGRAM WHICH THE RESULTS ARE UNKNOWN/NOT PROVIDED. OVER TIME, THE PORT STARTED TO ERODE THROUGH THE SKIN. THE PORT WAS ULTIMATELY REMOVED AND REPLACED. THE PORT HAD BEEN ACCESSED EVERY THREE WEEKS.

  Patient problems: Skin Erosion

  MAUDE report 15244653 ↗
• MalfunctionAug 17, 2022Fracture; Infusion or Flow Problem; Fracture; Infusion or Flow Problem

  THE PATIENT WAS REPORTED TO HAVE EXPERIENCED NO BLOOD RETURN WHEN THE SMARTPORT WAS ACCESSED FOR TREATMENT. DURING THE PATIENT'S LAST TREATMENT SESSION, THE PATIENT EXPERIENCED PUFFINESS ALONG THE INSERTION SITE, AND REPORTED PAIN IN LEFT SHOULDER. A PORTOGRAM WAS PERFORMED WHICH WAS NEGATIVE FOR ANY ISSUES. CATHFLO WAS GIVEN, BUT STILL NO BLOOD RETURN. THE PATIENT STILL REPORTED PAIN, SO A SECOND PORTOGRAM WAS PERFORMED WHICH SHOWED THE CATHETER HAD FRACTURED. THERE NO REPORT OF THE CATHETER MIGRATING. THE PORT AND CATHETER WERE REMOVED AND REPLACED.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15244621 ↗
• MalfunctionAug 17, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS REPORTED TO HAVE EXPERIENCED NO BLOOD RETURN WHEN PORT WAS ACCESSED ON (B)(6) 2022 FOR TREATMENT. THIS WAS REPORTED TO HAVE HAPPENED SEVERAL TIMES BUT RESOLVED WITH CATHFLO. CATHFLO WAS GIVEN, BUT STILL NO BLOOD RETURN, SO TREATMENT WAS UNABLE TO BE PROVIDED. THE PATIENT WAS SCHEDULED FOR REMOVAL OF HER PORT ON (B)(6) 2022 AND A REPLACEMENT PICC HAS BEEN ORDERED. THE PORT AND CATHETER WERE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244613 ↗
• MalfunctionAug 17, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS REPORTED TO HAVE EXPERIENCED NO BLOOD RETURN WHEN PORT WAS ACCESSED FOR TREATMENT. IT WAS REPORTED THIS HAS HAPPENED OVER MULTIPLE TREATMENTS. DURING THE PATIENT'S LAST TREATMENT SESSION, THE PATIENT EXPERIENCED PUFFINESS AROUND THE PORT. A PORTOGRAM WAS PERFORMED WHICH SHOWED A CLOT.THE PORT AND CATHETER WERE REMOVED AND REPLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 15244584 ↗
• MalfunctionAug 17, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS REPORTED TO HAVE EXPERIENCED NO BLOOD RETURN WHEN PORT WAS ACCESSED FOR TREATMENT. THE PATIENT REPORTED DISCOMFORT, AND THERE WAS PUFFINESS NEAR THE PORT AS IT WAS BEING FLUSHED. A PORTOGRAM WAS PERFORMED SHOWING A CLOT. IN ORDER TO ALLEVIATE THE CLOT, TPA WAS ADMINISTERS AN PRESSURE WAS APPLIED. TREATMENT WAS COMPLETED. IT WAS REPORTED THE PATIENT HAD EXPERIENCED NO BLOOD RETURN AT A LATER TREATMENT DATE. THE PORT AND CATHETER WERE REMOVED AND REPLACED. THE PORT HAD BEEN ACCESSED WEEKLY.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244454 ↗
• MalfunctionAug 17, 2022Migration or Expulsion of Device; Infusion or Flow Problem; Migration or Expulsion of Device; Infusion or Flow Problem

  IT WAS REPORTED THERE WAS NO BLOOD RETURN DURING MULTIPLE TREATMENT SESSIONS IN WHICH CATHFLO WAS USED IN ORDER TO OBTAIN A BLOOD RETURN. DURING THE PATIENT'S LAST TREATMENT SESSION, HE REPORTED TO BE EXPERIENCING PAIN. AFTER THE REPORT OF PAIN AND DISCOMFORT, PATIENT HAD A PORTOGRAM WHICH WAS NORMAL. OVER TIME, THE PORT STARTED TO ERODE THROUGH THE SKIN. THE PORT WAS ULTIMATELY REMOVED AND REPLACED.

  Patient problems: Pain; Skin Erosion

  MAUDE report 15244357 ↗

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