Smart Port CT H787CT96STSDVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15051684018197), received between Mar 14, 2025 and Jun 5, 2026 — classified as 2 deaths, 4 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2022, PLAINTIFF WAS DIAGNOSED WITH BREAST CANCER. THE TREATMENT FOR PLAINTIFF'S CANCER INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT CATHETER PLACED IN HER CHEST. ON OR ABOUT (B)(6), 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING ANGIODYNAMICS' "SMARTPORT", IDENTIFIED BY THE FOLLOWING: MODEL NO.: H787CT96STSDVII, LOT NO.: 5734495, LOG NO.: 1882935, DEVICE IDENTIFIER: 15051684018197, MANUFACTURER: ANGIODYNAMICS, INC., FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY, AT (B)(6), CA. ON OR ABOUT (B)(6), 2024, PLAINTIFF TESTED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS AT (B)(6), CA. ON OR ABOUT (B)(6) 2024, PLAINTIFF HAD THE SMARTPORT REMOVED BY (B)(6), CA.

  Patient problems: Bacterial Infection

  MAUDE report 25415203 ↗
• DeathApr 11, 2026Fracture

  ON OR ABOUT ON (B)(6) 2024, DECEDENT, UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: H787CT96STSDVI1, AND LOT NUMBER: A2823026. THE DEVICE WAS IMPLANTED AT (B)(6). DECEDENT'S PORT SYSTEM SUBSEQUENTLY BECAME INFECTED AND THE CATHETER PORTION OF THE DEVICE FRACTURED AND EMBOLIZED. DUE TO THESE COMPLICATIONS DECEDENT SUFFERED SUBSTANTIAL HARM AND REQUIRED EXTENSIVE MEDICAL CARE BUT ULTIMATELY DIED ON (B)(6) 2024. DECEDENT'S PRE-DEATH INJURIES INCLUDED BUT WERE NOT LIMITED TO: INFECTION, SHOCK, MULTIPLE SURGICAL PROCEDURES, BACTEREMIA, WEAKNESS, MALAISE, AND CARDIAC ARREST. SHE WAS ADMITTED AT (B)(6) FROM ON (B)(6) 2024, AND ON (B)(6) 2024. SHE WAS PRONOUNCED DEAD AT (B)(6).

  Patient problems: Bacteremia; Bacterial Infection; Cardiac Arrest; Malaise; Muscle Weakness/Atrophy; Shock

  MAUDE report 24848940 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2015, THE PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "POWER PORT." IDENTIFIED BY THE FOLLOWING: CATALOG NUMBER: CT96STSD-VI, LOT NUMBER: 4838077, LABEL PN 103035 REV. A, ANGIODYNAMICS, INC, FOR THE PURPOSES OF THE PLAINTIFF'S CONTINUED MEDICAL TREATMENT FOR SICKLE CELL ANEMIA AT A MEDICAL FACILITY LOCATED IN (B)(6). THIS ANGIODYNAMICS' DEVICE SUBSEQUENTLY CAUSED AN INFECTION TO DEVELOP IN THE PLAINTIFF. ACCORDINGLY, ON (B)(6) 2020, SURGERY WAS PERFORMED TO REMOVE THE PORT CATHETER, AND THE PLAINTIFF UNDERWENT EXTENSIVE TREATMENT FOR THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24403413 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS, INC. RECEIVED A NOTIFICATION FROM THE FDA OF AN EVENT REGARDING A CT W/9.6FR DETACHED SIL CATH & VI SMARTPORT. A PATIENT'S DAUGHTER REPORTED THAT HER MOTHER HAD THE PORT IMPLANTED FOR TREATMENT OF STAGE 4 BILIARY CANCER. THE PATIENT WAS HAVING SEVERE PAIN AT THE PORT SITE A WEEK AFTER THE PORT WAS PLACED. SHE WAS TAKEN TO THE EMERGENCY ROOM WHERE THEY UNCOVERED TWO LARGE BLOOD CLOTS. ONE WENT FROM THE INCISION IN HER NECK TO HER HAND AND THE OTHER FROM THE PORT THROUGH THE VESSEL LEADING TO HER HEART. SHE ALSO DEVELOPED THROMBOPHLEBITIS FROM THE PORT TUBE IN THE VESSEL. SHE WAS ADMITTED AND TREATED FOR THE CLOTS AND THROMBOPHLEBITIS. BEFORE HER DISCHARGE, THE DOCTORS WANTED TO DRAW BLOOD FROM THE PORT TO MAKE SURE THERE WAS NO BACTERIAL GROWTH. THEY TESTED THE PORT VIA SCAN AND FOUND THE PORT COULD RECEIVE THE CT FLUID, BUT THEY COULD NOT DRAW OUT FROM THE PORT. THE DECISION WAS MADE TO REMOVE THE PORT, AND SHE WAS FINALLY RELEASED. THE FOLLOWING INFORMATION WAS PROVIDED FROM THE EMERGENCY ROOMS PATIENT NOTES: "THE PATIENT UNDERWENT PORT PLACEMENT AND PRESENTED TO OUR FACILITY A WEEK LATER, COMPLAINING OF PAIN AND IRRITATION AROUND THE SITE. CALLED HER SURGEON'S OFFI

  Patient problems: Implant Pain; Skin Inflammation/ Irritation; Tachycardia; Thrombosis/Thrombus

  MAUDE report 23745703 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021 PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER H787CT96STSDVI1, LOT NUMBER 5666882. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD (B)(6) FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021 PLAINTIFF'S PORT WAS FOUND TO BE INFECTED AND PLAINTIFF WAS DIAGNOSED WITH SEPSIS. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2021 PLAINTIFF'S INFECTED PORT WAS REMOVED BY DR. (B)(6), MD AT INVERNESS SURGICAL ASSOCIATES.

  Patient problems: Sepsis

  MAUDE report 23086473 ↗
• DeathSep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2022, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER: CT96STSDVI1, AND LOT NUMBER: 5726567. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D. AT (B)(6). THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE DEVICE WAS IMPLANTED FOR THE ADMINISTRATION OF CHEMOTHERAPY TO TREAT DECEDENT'S CANCER. ON OR ABOUT ON (B)(6) 2023, DECEDENT PRESENTED TO (B)(6), WITH COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. UPON EVALUATION, DECEDENT WAS DIAGNOSED WITH A PORT CATHETER INFECTION CAUSED BY THE SMARTPORT. DECEDENT'S BLOOD CULTURES DRAWN FROM THE PORT SITE REVEALED DECEDENT WAS INFECTED WITH STAPHYLOCOCCUS HOMINIS, RESULTING IN PROBABLE SEPTIC SHOCK. ON OR ABOUT ON (B)(6) 2023, DECEDENT UNDERWENT REMOVAL OF THE DEFECTIVE SMARTPORT AT (B)(6). THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT ON (B)(6) 2023, DECEDENT PASSED AWAY WHILE STILL HOSPITALIZED.

  Patient problems: Bacterial Infection; Chest Pain; Dyspnea; Sepsis; Septic Shock

  MAUDE report 23063431 ↗
• MalfunctionJul 21, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ON OR ABOUT ON (B)(6) 2021, DEFENDANT (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER: CT96STSD, LOT NUMBER: 5669968. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), D.O., AT (B)(6). ON OR ABOUT ON (B)(6) 2021, DEFENDANT PRESENTED TO (B)(6) HOSPITAL FOR A PORT EVALUATION. THE PORT STUDY DEMONSTRATED THAT THE CATHETER FRACTURED AND MIGRATED INTO THE RIGHT VENTRICLE. ON OR ABOUT ON (B)(6) 2021, DEFENDANT UNDERWENT FRAGMENT RETRIEVAL. THIS PROCEDURE OCCURRED AT (B)(6) HOSPITAL AND WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT ON (B)(6) 2021, DEFENDANTS' DEFECTIVE SMARTPORT DEVICE WAS REMOVED FROM THE DECEDENT BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561740 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A CT W/9.6FR DETACHED SIL CATH & VI SMARTPORT, DURING A PROCEDURE. AFTER THE PEEL AWAY DILATOR WAS INSERTED AND UPON REMOVAL THE HUB SEPARATED FROM THE DILATOR, LEAVING IT RETAINED INSIDE THE PEEL AWAY SHEATH. THIS WAS IMMEDIATELY NOTED BY THE SCRUB TECH, WHO THEN ALERTED THE PHYSICIAN, AND THE FRAGMENTED DEVICE WAS REMOVED, WITHOUT INCIDENT. THE FRAGMENT REMAINED INSIDE OF THE SHEATH, AT ALL TIMES, AND WAS NOT LOOSE WITHIN THE PATIENT'S BODY. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606287 ↗

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