Smart Port CT H787CT75STSD0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15051684018005), received between May 20, 2025 and Sep 27, 2026 — classified as 1 death, 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Chest Pain; Chills; Confusion/ Disorientation; Fatigue; Fever; Medical device site infection

  MAUDE report 50909990 ↗
• MalfunctionApr 26, 2026Fracture

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER H787CT75ST800, AND LOT NUMBER 5272267. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF LONG-TERM IV ACCESS. ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT A CHEST X-RAY WHICH REVEALED THAT PLAINTIFF'S SMARTPORT WAS FRACTURED. ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT REMOVAL OF THE SMARTPORT AND PLACEMENT OF AN ANGIODYNAMICS XCELA PORT CATHETER PRODUCT AT (B)(6) BY DR. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24993620 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO 2021, PLAINTIFF WAS DIAGNOSED WITH MYELODYSPLASTIC SYNDROME, A FORM OF BLOOD CANCER. THE TREATMENT FOR PLAINTIFFS' CANCER INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HER. ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "SMARTPORT", IDENTIFIED BY THE FOLLOWING: MODEL NUMBER: CT75STSD, LOT NUMBER: 5723799, MANUFACTURER: ANGIODYNAMICS, INC. 26 FOREST STREET, MARLBOROUGH, MA 01752, FOR THE PURPOSES OF PLAINTIFFS CHEMOTHERAPY AT (B)(6). SUBSEQUENT TO THE PLACEMENT OF THE AFOREMENTIONED SMARTPORT, THE PLAINTIFF WAS CAUSED TO DEVELOP AN INFECTION, IDENTIFIED AS BACTEREMIA / SEPSIS, WHICH UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. THE PLAINTIFF UNDERWENT MEDICAL TREATMENT FOR THE INFECTION. AS PART OF THIS MEDICAL TREATMENT FOR THE INFECTION, PLAINTIFF WAS ADMITTED TO (B)(6) FOR MEDICAL SCIENCES CENTER ON OR ABOUT (B)(6) 2023, FOR TREATMENT OF BACTEREMIA/SEPSIS WHICH, UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. AS FURTHER TREATMENT FOR THE INFECTIONS, ON OR ABOUT (B)(6) 2023, THE PORT CATHETER WAS REM

  Patient problems: Bacteremia; Sepsis

  MAUDE report 24817763 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT RIGHT INTERNAL JUGULAR VEIN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT PORT CATHETER PRODUCT, WITH MODEL NUMBER H787CT75STSD0, AND LOT NUMBER 5776465. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2025, PLAINTIFF WAS ADMITTED TO (B)(6) IN (B)(6), FOR A SICKLE CELL CRISIS. DURING PLAINTIFF'S HOSPITALIZATION, HE WAS FOUND TO HAVE BACTEREMIA. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT IT NEEDED TO BE REMOVED. ON OR ABOUT (B)(6) 2025, PLAINTIFF, WHILE HOSPITALIZED AT (B)(6), UNDERWENT REMOVAL OF THE DEFECTIVE SMARTPORT. THE PROCEDURE WAS PERFORMED BY DR.(B)(6), M.D.

  Patient problems: Bacteremia

  MAUDE report 24730881 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER H787CT75STSD0, AND LOT NUMBER 5557030. THE DEVICE WAS IMPLANTED BY(B)(6), MD AT (B)(6) IN (B)(6) FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S PORT WAS FOUND TO BE POSITIVE FOR STREPTOCOCCI AND ENTEROCOCCUS FAECALIS. PLAINTIFF DEVELOPED SEPSIS DUE TO THE INFECTION FROM THE PORT AND AFTER 14 DAYS IN THE HOSPITAL PASSED AWAY. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S PORT WAS REMOVED BY (B)(6) AT (B)(6), (B)(6). PLAINTIFF PASSED DUE TO COMPLICATIONS FROM THE PORT, INCLUDING SEPSIS.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 24728709 ↗
• MalfunctionMar 10, 2026Fracture

  ON OR ABOUT (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6) TO UNDERGO LEFT INTERNAL JUGULAR PLACEMENT OF DEFENDANTS' SMARTPORT PRODUCT, WITH MODEL NUMBER CT75STSD, AND LOT NUMBER 4824769. THIS SMARTPORT PRODUCT IS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6) PA-C, AT (B)(6) HOSPITAL IN (B)(6). ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), FOR A FLUOROSCOPIC PORT CHECK AS THE SMARTPORT WAS MALFUNCTIONING. THE PORT CHECK REVEALED A CATHETER FRACTURE WITH CONTRAST EXTRAVASATION, WHICH WOULD REQUIRE REMOVAL OF THE SMARTPORT. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED (B)(6) HOSPITAL IN (B)(6), TO UNDERGO REMOVAL OF THE SMARTPORT. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Extravasation

  MAUDE report 24562599 ↗
• MalfunctionMar 2, 2026Fracture

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH AN UNKNOWN PRODUCT CODE, AND WITH LOT NUMBER 4868686. THE SMARTPORT DEVICE WAS IMPLANTED BY (B)(6), PA-C, AT (B)(6) HOSPITAL IN (B)(6), NEW MEXICO, AND THE PURPOSE OF IMPLANTATION OF THE SMARTPORT WAS TO ADMINISTER CHEMOTHERAPY TO TREAT PLAINTIFF'S LYMPHOMA. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), NEW MEXICO, WITH COMPLAINTS OF A DYSFUNCTIONAL PORT. PLAINTIFF UNDERWENT A SCAN, AND IT WAS FOUND THAT THERE WAS A FOCAL AREA OF EXTRAVASATION WITHIN THE SMARTPORT CATHETER. PLAINTIFF'S MEDICAL TEAM RECOMMENDED THAT THE PORT BE REMOVED. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), NEW MEXICO, TO UNDERGO REMOVAL OF THE SMARTPORT. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

  Patient problems: Extravasation

  MAUDE report 24479968 ↗
• MalfunctionDec 13, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT ON (B)(6) 2024, PLAINTIFF UNDERWENT LEFT SUBCLAVIAN VEIN PLACEMENT OF THE ANGIODYNAMICS SMARTPORT PRODUCT WITH MODEL NUMBER: H787CT75STSD0, LOT NUMBER: 5776465. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6) AT (B)(6) FOR THE PURPOSE OF TREATING IRON DEFICIENCY ANEMIA. ON OR ABOUT ON (B)(6) 2024, PLAINTIFF BEGAN EXPERIENCING LEFT HAND PAIN AND NUMBNESS AS WELL AS ISSUES WITH INFUSIONS INTO THE PORT AND PATIENT WAS REFERRED FOR PORT REMOVAL. SUBSEQUENTLY, ON OR ABOUT ON (B)(6) 2024, PLAINTIFF UNDERWENT THE REMOVAL OF THE SMARTPORT DEVICE BY DR. (B)(6) AT (B)(6) HOSPITAL. HOWEVER, DURING THIS REMOVAL, IT WAS DISCOVERED THAT THE PLAINTIFF'S PORT CATHETER HAD FRACTURED AND ONLY APPROXIMATELY 5CM OF THE PORT CATHETER WAS ABLE TO BE REMOVED. SUBSEQUENTLY, ON OR ABOUT ON (B)(6) 2024, PLAINTIFF UNDERWENT AN ADDITIONAL REMOVAL PROCEDURE BY DR. (B)(6) AT (B)(6) WHEREIN THE REMAINING CATHETER FRAGMENT FROM THE RIGHT ATRIUM WAS SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797688 ↗
• InjuryDec 2, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2024, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT DEVICE, CATALOG NUMBER CT75STSD, LOT NUMBER 5829450. THE DEVICE WAS IMPLANTED BY (B)(6) M.D. AT (B)(6), FOR THE PURPOSE OF ONGOING VEIN ACCESS FOR CHEMOTHERAPY TO TREAT PLAINTIFF'S BREAST CANCER. ON OR ABOUT (B)(6) 2025, THE PLAINTIFF PRESENTED TO DR. (B)(6) OFFICE AND REPORTED THAT AT A RECENT CHEMOTHERAPY VISIT, HER SMARTPORT CT WAS UNABLE TO BE ACCESSED AND THERE WAS SOME INFILTRATION OF THE CHEST WALL THAT RESULTED IN SOME CHEMICAL BURNING. SHE COMPLAINED OF PAIN IN HER ANTERIOR CHEST WALL UNDERNEATH HER PORT. DR. (B)(6) DETERMINED THAT THE PLAINTIFF'S SMARTPORT CT NEEDED TO BE REPLACED. ON OR ABOUT (B)(6) 2025, PLAINTIFF UNDERWENT A RADICAL MASTECTOMY FOR TREATMENT OF HER BREAST CANCER, AS WELL AS THE REMOVAL OF HER SMARTPORT CT. THE PROCEDURE WAS PERFORMED BY (B)(6) M.D. AT (B)(6). DURING THIS PROCEDURE, IT WAS REVEALED THAT THE CATHETER PORTION OF THE SMARTPORT CT HAD FRACTURED. DR. (B)(6) WAS ABLE TO REMOVE THE PORT AND PART OF THE FRACTURED CATHETER; HOWEVER, A FRAGMENT OF THE CATHETER WAS RETAINED IN THE PLAINTIFF INTRAVASCULARLY. AT THIS POINT, DR. (B)(6) CONSULTED INTRAOPERATIVELY WI

  Patient problems: Caustic/Chemical Burns; Chest Pain; Implant Pain; Infiltration into Tissue

  MAUDE report 23696834 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT LEFT SUBCLAVIAN PLACEMENT OF AN ANGIODYNAMICS VORTEX IMPLANTABLE PORT CATHETER SYSTEM, WITH MODEL NUMBER H787CT75STSD0, AND LOT NUMBER 5378426. THIS VORTEX DEVICE WAS COMPRISED OF A PORT BODY AND SILICONE CATHETER. THE VORTEX WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER, IN (B)(6). ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), WITH COMPLAINTS OF A FEVER AND DRAINAGE FROM THE PORT SITE. BLOOD CULTURES WERE DRAWN AND CAME BACK POSITIVE FOR SEPSIS, REQUIRING REMOVAL OF THE VORTEX. ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE DEVICE. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: Fever; Purulent Discharge; Sepsis

  MAUDE report 23449571 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, (B)(6) UNDERWENT PLACEMENT OF THE FOLLOWING ANGIODYNAMICS' SMARTPORT CT PRODUCT: UPN: H787CT75STSD0; LOT NO: 5649837. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 7.5F X 66CM SILICONE CATHETER AND 8F INTRODUCER KIT. THE PORT-A-CATH AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD., AT (B)(6) HOSPITAL IN (B)(6) FOR DECEDENT'S CHEMOTHERAPY. ON (B)(6) 2022, DECEDENT PRESENTED TO (B)(6) IN (B)(6), FOR A SCHEDULED REMOVAL OF HIS PORT-A-CATH. UPON INFORMATION AND BELIEF, DECEDENT'S PORT-A-CATH WAS FOUND TO BE INFECTED PRIOR TO THE REMOVAL PROCEDURE. DUE TO THE AFOREMENTIONED SERIOUS COMPLICATIONS RELATED TO THE CATHETER, DECEDENT'S CATHETER WAS REMOVED BY DR. (B)(6) MD, AT (B)(6) IN (B)(6).

  Patient problems: Medical device site infection

  MAUDE report 23050917 ↗
• InjuryAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2012, THE PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "SMART PORT", IDENTIFIED BY THE FOLLOWING: CATALOG NUMBER: CT75STSD, LOT NUMBER: 569291 FOR THE PURPOSES OF THE PLAINTIFFS CONTINUED MEDICAL TREATMENT. ON OR ABOUT (B)(6) 2021, THE DEVICE AT WAS IMPLANTED BY DR. (B)(6) AT (B)(6) FOR THE PURPOSES INDICATED ABOVE. THEREAFTER, THE PLAINTIFF DEVELOPED MULTIPLE INFECTIONS AS DIAGNOSED BY HER HEALTH CARE PROVIDERS. THE PLAINTIFF RECEIVED MEDICAL CARE AND TREATMENT FOR THE ABOVE MEDICAL CONDITIONS. FURTHER, THE PLAINTIFFS SMART PORT CATHETER FRACTURED, AND PIECES OF THE CATHETER DID BECOME LODGED IN HER VEINOUS SYSTEM AND HER HEART. AS A RESULT, THE PLAINTIFF REQUIRED MEDICAL CARE AND TREATMENT AND UNDERWENT MULTIPLE SURGERIES TO REMOVE FRAGMENTS OF THE FRACTURED CATHETER. ON OR ABOUT (B)(6) 2022, THE PLAINTIFF UNDERWENT SURGERY FOR REMOVAL OF RETAINED INTRA VASCULAR CATHETER FROM HER SUPERIOR VENA CAVA, A PATCH ANGIOPLASTY OF THE SUPERIOR VENA CAVA WITH NATIVE VENA CAVA UTILIZING CARDIOPULMONARY BYPASS, AT THE (B)(6).

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 22897240 ↗
• InjuryMay 20, 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, MODEL NUMBER CT75STSD, LOT NUMBER 5673779. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), AT (B)(6). ON OR ABOUT APRIL 16, 2022, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF INTRACTABLE VOMITING. BLOOD CULTURES WERE OBTAINED AND GREW STAPHYLOCOCCUS CAPRIE. HIS MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION. ON OR ABOUT (B)(6) 2022, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), AT (B)(6).

  Patient problems: Bacterial Infection; Vomiting

  MAUDE report 22057458 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT, MODEL NUMBER H787CT75STSD0, LOT NUMBER 5753716. THE SMARTPORT WAS IMPLANTED BY DR. JAMES A. YORK, M.D., AT FORREST HEALTH. ON OR ABOUT DECEMBER 19, 2022, PLAINTIFF PRESENTED TO FOREST HEALTH WITH COMPLAINTS OF A FEVER. BLOOD CULTURES WERE OBTAINED AND RETURNED POSITIVE FOR MRSA, AND PLAINTIFF WAS DIAGNOSED WITH SEPSIS. HIS MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION. ON OR ABOUT (B)(6) 2022, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6) M.D., AT FOREST HEALTH.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis

  MAUDE report 22057457 ↗

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