Smart Port CT H787CT75STSDVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15051684018135), received between Jun 9, 2025 and Jan 19, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER CT75STSD-VI, AND LOT NUMBER 5666879. THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6)., M.D., AT (B)(6), AND THE PURPOSE OF IMPLANTATION OF THE SMARTPORT WAS TO TREAT PLAINTIFF'S SICKLE CELL DISEASE. DEFENDANTS, DIRECTLY OR THROUGH THEIR AGENTS, APPARENT AGENTS, SERVANTS, OR EMPLOYEES DESIGNED, MANUFACTURED, MARKETED, ADVERTISED, DISTRIBUTED, AND SOLD THE SMARTPORT THAT WAS IMPLANTED IN PLAINTIFF. DEFENDANTS MANUFACTURED, SOLD, AND/OR DISTRIBUTED THE SMARTPORT TO PLAINTIFF, THROUGH PLAINTIFF'S DOCTORS, TO BE USED FOR VEIN ACCESS. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF PAIN AND SWELLING NEAR HER PORT SITE. BLOOD CULTURES WERE DRAWN AND CAME BACK POSITIVE FOR AN INFECTION, REQUIRING REMOVAL OF THE SMARTPORT. ON (B)(6) 2022, PLAINTIFF UNDERWENT REMOVAL OF THE SMARTPORT, AND THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6). DURING THE REMOVAL PROCEDURE ON OR ABOUT (B)(6) 2022, DR. (B)(6) NOTED THAT PURULENT FLUID WAS EXPRESSED FROM THE PORT P

  Patient problems: Bacteremia; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 24109516 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED THE FOLLOWING ISSUE WITH A CT W/7.5FR DET CATH & VI SMARTPORT: "PATIENT HAD AN ANGIODYNAMICS PORT PLACED BY DR. (B)(6) ON (B)(6). PATIENT ARRIVED AT THE CANCER INSTITUTE ON (B)(6). PORT WAS ACCESSED AND NO BLOOD RETURN NOTED. CATH FLO WAS PLACED AND UNSUCCESSFUL. MD NOTIFIED AND PORTOGRAM WAS ORDERED. COMPLETED ON (B)(6) AND IT SHOWED: DISCONTINUITY OF THE PATIENT'S CENTRAL CATHETER WHICH APPEARS TO HAVE SHEARED AT THE LEVEL OF THE CHEST WALL. THE LOOSE FRAGMENT OF THE CATHETER IS LARGELY WITHIN THE RIGHT ATRIUM. PATIENT WAS THEN SENT TO THE ER AND WAS TRANSFERRED TO GMH TO HAVE THE DEVICE REMOVED FROM RIGHT ATRIUM." DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692422 ↗
• InjurySep 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, (B)(6). UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT CT DEVICE, CATALOG # CT75STSD-VI, LOT # 4792614. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMARTPORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 7.5F X 66CM SILICONE CATHETER AND 8F INTRODUCER KIT (WITH VALVED INTRODUCER). THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) HOSPITAL, IN (B)(6), FOR THE TREATMENT OF PLAINTIFF'S MEDICAL CONDITION. ON (B)(6) 2015, (B)(6). PRESENTED TO (B)(6) HOSPITAL IN (B)(6). AT THAT TIME, (B)(6) MEDICAL TEAM DETERMINED THAT HER SMARTPORT CT WAS INFECTED AND THAT THE INFECTED PORT-A-CATH HAD TO BE REMOVED. ON (B)(6) 2015, (B)(6) DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), MD, AT (B)(6) HOSPITAL, IN (B)(6). ON (B)(6) 2015, THE POST-OPERATIVE DIAGNOSIS REVEALED THAT (B)(6).'S PORT-A-CATH AT ISSUE WAS INFECTED. AFTER REMOVAL OF THE INFECTED SMARTPORT CT PORT-A-CATH, PLAINTIFF DID NOT HAVE AN OPPORTUNITY TO CONSULT WITH DR. (B)(6), M.D. ABOUT THE CAUSES OF HER CATHETER INFECTION AND HER POST-OPERATIVE DIAGNOSIS OF THE INFECTED PORT-A-CATH. PLAINTIFF KNEW SHE HAD AN INFECTION, BUT SHE DID NOT KNOW HER INFECTION WAS CAUSED BY THE SMARTPORT CT'S

  Patient problems: Medical device site infection

  MAUDE report 23048097 ↗
• InjuryJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A CT W/7.5FR DET CATH & VI SMARTPORT. DURING A PLACEMENT PROCEDURE, THE SILICONE CATHETER BROKE OFF AND WENT INTO THE PATIENT'S VEIN. THE PATIENT WAS TRANSFERRED TO (B)(6) BY MEDICAL HELICOPTER, AND THE FRAGMENT WAS REMOVED BY INTERVENTIONAL RADIOLOGY ON THE SAME DAY. THE DEVICE HAD BEEN INSPECTED PRIOR TO INSERTION IN THE PATIENT. NO FURTHER DETAILS COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22172704 ↗

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