Smart Port CT H787CT96STSA0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15051684018050), received between Jun 6, 2025 and Sep 23, 2026 — classified as 3 injuries.

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.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2025, Plaintiff underwent placement of an AngioDynamics SmartPort port catheter product, with model number H787CT96STSA0, and lot number 5842032. This SmartPort devices consisted of a port body and a polyurethane catheter. The SmartPort device was implanted by Dr. (b)(6)MD., at (b)(6) Medical Center, (b)(6), for the purpose of ongoing chemotherapy treatment.On (b)(6) 2025, Plaintiff (b)(6) presented to (b)(6) Medical Center, (b)(6), with complaints of chest pain, generalized weakness, and sinus tachycardia. A sepsis alert was activated and a sepsis protocol initiated, after which Plaintiff was diagnosed with sepsis.

  Patient problems: Chest Pain; Muscle Weakness/Atrophy; Sepsis; Tachycardia

  MAUDE report 50863274 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2024, Plaintiff underwent placement of an AngioDynamics SmartPort port catheter product, with model number H787CT80STPD0, and lot number 5821731. This SmartPort device consisted of a port body and a polyurethane catheter.The SmartPort device was implanted by Dr. (b)(6) MD. under the supervision of Dr. (b)(6) MD., at (b)(6), for the purpose of ongoing chemotherapy treatment.On or about (b)(6) 2025, Plaintiff (b)(6) presented to (b)(6) Hospital in (b)(6), with complaints of fever since that morning. She was admitted with concern for neutropenic fever with sepsis and hospital- acquired pneumonia. Blood cultures from the port were positive for Staphylococcus epidermidis likely contaminant at port site. Blood cultures drawn on (b)(6) 2025, from the port site, were positive for Staphylococcus epidermidis in 1 of 2 bottles. Found to have methicillin resistant Staphylococcus epidermidis bacteria in one bottle.On or about (b)(6) 2025, medical recommendation was to discontinue vancomycin given negative MRSA nares swab. Continue cefepime. Discontinue blood culture collection. The assessment at the time was that patient is colonized or contaminant at port site vs low concern

  Patient problems: Fever; Pneumonia; Sepsis

  MAUDE report 50863273 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, DECEDENT (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER H787CT96STSA0, LOT NUMBER 5673772. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL - (B)(6), IN (B)(6). ON OR ABOUT (B)(6) 2022, DECEDENT PRESENTED TO (B)(6) HOSPITAL - (B)(6), IN (B)(6), WITH SYMPTOMS OF AN INFECTION, SUBSEQUENTLY BEING DIAGNOSED WITH HAVING AN INFECTED PORT CATHETER THAT REQUIRED REMOVAL AND IN-HOSPITAL TREATMENT FOR THE INFECTION. ON OR ABOUT (B)(6) 2022, DEFENDANTS' DEFECTIVE SMARTPORT DEVICE WAS REMOVED FROM DECEDENT BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL - (B)(6), IN (B)(6).

  Patient problems: Medical device site infection

  MAUDE report 22159562 ↗

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