Smart Port CT H787CT75STSA0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15051684017992), received between Apr 22, 2025 and Feb 5, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 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.

• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  A PATIENT REPORTED AN ISSUE WITH THEIR SMARTPORT CT 7.5F SL TI STD FILLED ATT SIL. THE PATIENT HAD THEIR PORT PLACED ON (B)(6) 2024 AT (B)(6) HOSPITAL (B)(6), BY DR. (B)(6). WHILE THE PORT WAS IN PLACE; IT REQUIRED MANY FLUSHES. ON (B)(6) 2025, DR. (B)(6) ATTEMPTED TO REMOVE THE PORT AND A PORTION OF THE CATHETER BUT COMMENTED THAT IT SHOULD BE LONGER. IT WAS THEN REALIZED THAT A PORTION OF THE CATHETER MAY HAVE DETACHED, WITHIN THE PATIENT. ON (B)(6) 2025, THE PATIENT HAD A FOLLOW-UP APPOINTMENT AT (B)(6) IN (B)(6), WITH HER SURGEON DR. (B)(6), WHERE A CHEST X-RAY SHOWED THAT A FRAGMENT OF THE CATHETER WAS IN THE PATIENT'S PULMONARY ARTERY. THE FRAGMENT WAS REMOVED VIA A PROCEDURE ON (B)(6) 2025 AND THE PATIENT DID NOT EXPERIENCE ANY HARM OR ADVERSE EFFECTS AS A RESULT OF THIS MALFUNCTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24274586 ↗
• MalfunctionSep 17, 2025Fracture; Detachment of Device or Device Component; Migration; Fracture; Detachment of Device or Device Component; Migration

  ON OR ABOUT (B)(6)2012, PLAINTIFF UNDERWENT RIGHT SUBCLAVIAN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER CT75STSA. THIS SMARTPORT PRODUCT IS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) IN (B)(6) FOR THE PURPOSE OF CHEMOTHERAPY ADMINISTRATION TO TREAT PLAINTIFF'S BREAST CANCER. ON OR ABOUT EARLY (B)(6)2013, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), FOR A CHEMOTHERAPY TREATMENT, AND SUBSEQUENTLY HAD COMPLAINTS OF SIGNIFICANT PAIN IN HER RIGHT SHOULDER UPON ACCESSING AND FLUSHING THE PORT. PLAINTIFF UNDERWENT IMAGING WHICH DEMONSTRATED A FRACTURED CATHETER WITH EXTRAVASATION. ON OR ABOUT (B)(6)2013, PLAINTIFF PRESENTED TO DR. (B)(6) AT (B)(6) IN(B)(6),, FOR REMOVAL OF THE SMARTPORT, WHEREBY DR. (B)(6) REMOVED THE SMARTPORT BODY AND A SHORT SEGMENT OF THE DEVICE'S CATHETER. DR. (B)(6) WAS UNSUCCESSFUL IN REMOVING THE FRACTURED CATHETER FRAGMENT, WHICH REMAINED IN PLAINTIFF'S BODY. ON OR ABOUT (B)(6)2013, DR. (B)(6) REFERRED PLAINTIFF TO DR. (B)(6) A VASCULAR SURGEON, FOR EVALUATION OF THE RETAINED CATHETER FRAGMENT, WHICH WAS NOTED TO HAVE MIGRATED TO PLAINTIFF'S RIGHT VENTRICLE. D

  Patient problems: Pain

  MAUDE report 23075034 ↗
• MalfunctionApr 22, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ON OR ABOUT ON (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CATHETER PRODUCT, MODEL NUMBER: CT75STSA, LOT NUMBER: 5742657. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D, AT (B)(6). ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF CHEST PAIN AND DIFFICULTY BREATHING. PLAINTIFF UNDERWENT A CT SCAN OF THE PULMONARY ARTERIES, WHICH DEMONSTRATED THAT HER PORT HAD FRACTURED AND MIGRATED TO HER RIGHT PULMONARY ARTERY. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF'S CATHETER FRAGMENT WAS REMOVED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL. ON OR ABOUT ON (B)(6) 2023, PLAINTIFF UNDERWENT AN ADDITIONAL PROCEDURE TO HAVE THE REMAINING PORT REMOVED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL.

  Patient problems: Chest Pain; Dyspnea; Foreign Body In Patient

  MAUDE report 21882414 ↗

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