Smart Port CT H787CT66LTPD0Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15051684017978), received between Jul 24, 2025 and Sep 24, 2026 — classified as 10 injuries, 3 malfunctions.

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

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Prior to 2024, Plaintiff was diagnosed with breast cancer. Plaintiff's cancer treatment included chemotherapy. In order to administer chemotherapy medications, Plaintiff's physicians placed a port catheter in her chest.On or about (b)(6) 2024, Plaintiff underwent placement of an Angio Dynamics "Smart Port," identified as follows: UPN: H787CT66LTPD0; Lot Number: Al624008; Manufacturer: Angio Dynamics, Inc. The Smart Port was placed at (b)(6) for purposes of administering Plaintiff's chemotherapy.On or about (b)(6) 2024, Plaintiff presented to (b)(6) with discomfort extending from the left side of her neck to her ear and shoulder region, down to the axilla, as well as a sensation of pressure at the site where the port had been placed. Plaintiff was diagnosed with acute embolism and thrombosis of the left subclavian vein, left axillary vein, and left internal jugular vein. (b)(4)- 1319211-2026-00322).On or about (b)(6) 2024, Plaintiff was diagnosed with deep vein thrombosis ("DVT") and continued treatment with Eliquis, 5 mg. (b)(4)- 1319211-2026-00323).On or about (b)(6) 2024, Plaintiff underwent removal of the Smart Port at (b)(6) .

  Patient problems: Ear Pain; Embolism/Embolus; Implant Pain; Neck Pain; Thrombosis/Thrombus

  MAUDE report 50876767 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Prior to 2024, Plaintiff was diagnosed with breast cancer. Plaintiff's cancer treatment included chemotherapy. In order to administer chemotherapy medications, Plaintiff's physicians placed a port catheter in her chest.On or about (b)(4) 2024, Plaintiff underwent placement of an Angio Dynamics "Smart Port," identified as follows: UPN: H787CT66LTPD0; Lot Number: Al624008; Manufacturer: Angio Dynamics, Inc. The Smart Port was placed at (b)(6) in (b)(6) for purposes of administering Plaintiff's chemotherapy.On or about (b)(6) 2024, Plaintiff presented to (b)(6) with discomfort extending from the left side of her neck to her ear and shoulder region, down to the axilla, as well as a sensation of pressure at the site where the port had been placed. Plaintiff was diagnosed with acute embolism and thrombosis of the left subclavian vein, left axillary vein, and left internal jugular vein. (b)(4) ,1319211-2026-00322).On or about (b)(6) 2024, Plaintiff was diagnosed with deep vein thrombosis ("DVT") and continued treatment with Eliquis, 5 mg. (b)(4),1319211-2026-00323).On or about (b)(6) 2024, Plaintiff underwent removal of the Smart Port at (b)(6) .

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50876766 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  On or about (b)(6) 2017, Plaintiff underwent left internal jugular placement of an Angio Dynamics Smart Port CT port catheter product, with model number CT66LTPD, and lot number 5207252. The Smart Port was implanted by Dr. (b)(6), M.D., at (b)(6) .On or about (b)(6) 2020, while hospitalized at (b)(6) for cholangitis, blood was drawn from Plaintiff's Smart Port, and the culture results were positive for infection. Based on these findings, removal of the Smart Port was recommended.On or about (b)(6) 2020, while hospitalized at (b)(6) , Plaintiff underwent removal of the Smart Port secondary to bacteremia. The removal procedure was performed by Dr. (b)(6), M.D.On or about (b)(6) 2020, positive blood cultures indicated the presence of klebsiella variicola.

  Patient problems: Bacteremia

  MAUDE report 50876705 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT CATHETER PRODUCT, MODEL NUMBER H787CT66LTPD0, LOT NUMBER 5497675.THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT NOVEMBER 6, 2022, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF MALAISE AND FEVER. PLAINTIFF UNDERWENT TESTING WHICH DETERMINED DIAGNOSIS OF E. COLI BACTEREMIA WHICH RESULTED IN REMOVAL OF THE SMARTPORT. THE PORT REMOVAL WAS PERFORMED BY DR. (B)(6).

  Patient problems: Bacteremia; Bacterial Infection; Fever; Malaise

  MAUDE report 24680430 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF (B)(6). UNDERWENT AN INSERTION OF A RIGHT INTERNAL JUGULAR VEIN CENTRAL VENOUS ACCESS PORT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT66LTPD, LOT NUMBER UNKNOWN. UPON INFORMATION AND BELIEF, THIS SMARTPORT DEVICE CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT WAS IMPLANTED AT (B)(6). PLAINTIFF AND HER HEALTH CARE PROVIDERS USED THE SMARTPORT IN A NORMAL, CUSTOMARY, INTENDED, AND FORESEEABLE MANNER, NAMELY AS A SURGICALLY PLACED DEVICE USED TO MAKE IT EASIER TO DELIVER MEDICATIONS DIRECTLY INTO THE PLAINTIFF'S BLOODSTREAM. MOREOVER, PLAINTIFF'S HEALTH CARE PROVIDERS DID NOT PLACE OR MAINTAIN THE DEVICE INCORRECTLY SUCH THAT IT CAUSED THE DEVICE TO "PINCH OFF" OR OTHERWISE MALFUNCTION. ON OR ABOUT (B)(6) 2025, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL FOR PAIN AND WAS DIAGNOSED WITH AN INFECTION CAUSED BY HER SMARTPORT DEVICE. THIS ULTIMATELY RESULTED IN THE REMOVAL OF HER SMARTPORT DEVICE ON (B)(6) 2025, AT (B)(6) HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 24479934 ↗
• InjuryFeb 10, 2026Detachment of Device or Device Component

  ON OR ABOUT ON (B)(6) 2019, MINOR PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMART PORT PRODUCT, MODEL NUMBER: H787CT66LTPD0 AND LOT NUMBER: 5468432, COMPROMISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6), FOR THE PURPOSE OF ALLOWING FOR EASIER IV ACCESS AND TRANSFUSION. ON OR ABOUT ON (B)(6) 2021, MINOR PLAINTIFF PRESENTED TO (B)(6), WHERE A PORT INFECTION WAS DISCOVERED. MINOR PLAINTIFF WAS DISCHARGED ON OR ABOUT ON (B)(6) 2021, WITH ANTIBIOTICS. (B)(4). ON OR ABOUT ON (B)(6) 2022, MINOR PLAINTIFF PRESENTS TO (B)(6) AND UNDERWENT A BLOOD CULTURE PANEL BY DR. (B)(6) M.D., AT, DURING WHICH A PORT INFECTION WAS DISCOVERED. DUE TO THE SECOND INFECTION, MINOR PLAINTIFF'S MEDICAL TEAM DECIDED TO REMOVE THE DEFECTIVE SMART PORT TO TRY TO AVOID FURTHER INFECTIONS. (B)(4). ON OR ABOUT ON (B)(6) 2022, MINOR PLAINTIFF WAS TRANSFERRED TO (B)(6), FOR PORT REMOVAL. OR ABOUT ON (B)(6) 2022, MINOR PLAINTIFF UNDERWENT AN ATTEMPTED REMOVAL OF THE PORT AND CATHETER BY DR. (B)(6) M.D., AT (B)(6). DURING THE ATTEMPTED REMOVAL OF THE CATHETER, THE PROCEDURE WAS STOPPED BECAUSE THE DEVICE HAD MERGED INTO MINOR PLAINTIFF'S BONE AND BODILY TI

  Patient problems: Bacterial Infection; Foreign Body In Patient

  MAUDE report 24305106 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2019, MINOR PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMART PORT PRODUCT, MODEL NUMBER: H787CT66LTPD0 AND LOT NUMBER: 5468432, COMPROMISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6), FOR THE PURPOSE OF ALLOWING FOR EASIER IV ACCESS AND TRANSFUSION. ON OR ABOUT (B)(6) 2021, MINOR PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), WHERE A PORT INFECTION WAS DISCOVERED. MINOR PLAINTIFF WAS DISCHARGED ON OR ABOUT (B)(6) 2021, WITH ANTIBIOTICS. ((B)(4)). ON OR ABOUT (B)(6) 2022, MINOR PLAINTIFF PRESENTS TO (B)(6) MEDICAL CENTER IN (B)(6), AND UNDERWENT A BLOOD CULTURE PANEL BY DR. (B)(6) M.D., AT, DURING WHICH A PORT INFECTION WAS DISCOVERED. DUE TO THE SECOND INFECTION, MINOR PLAINTIFF'S MEDICAL TEAM DECIDED TO REMOVE THE DEFECTIVE SMART PORT TO TRY TO AVOID FURTHER INFECTIONS. ((B)(4)). ON OR ABOUT (B)(6) 2022, MINOR PLAINTIFF WAS TRANSFERRED TO (B)(6), FOR PORT REMOVAL. OR ABOUT (B)(6) 2022, MINOR PLAINTIFF UNDERWENT AN ATTEMPTED REMOVAL OF THE PORT AND CATHETER BY DR. (B)(6) M.D., AT (B)(6). DURING THE ATTEMPTED REMOVAL OF THE CATHETER, THE PROCEDURE WAS STOPPED BECAUSE THE DEVICE HAD MERGED INTO

  Patient problems: Bacterial Infection

  MAUDE report 24305105 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER H787CT66LTPD0 AND LOT NUMBER 5504873. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) HOSPITAL IN (B)(6), FOR CHEMOTHERAPY TREATMENT. THIS SMARTPORT DEVICE IS COMPRISED OF A PORT BODY AND POLYURETHANE CATHETER. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF DRAINAGE AT THE PORT SITE AND ERYTHEMA. BLOOD CULTURES WERE DRAWN FROM THE PORT AND CAME BACK POSITIVE FOR AN INFECTION. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT NEEDED TO BE REMOVED. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6).

  Patient problems: Bacterial Infection; Erythema; Purulent Discharge

  MAUDE report 23450915 ↗
• 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 PRESENTED TO (B)(6) HOSPITAL IN (B)(6), TO UNDERGO RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, WITH MODEL NUMBER H787CTE6LTPD, AND LOT NUMBER 5647356. THIS SMARTPORT PRODUCT IS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE (B)(6) 2021, IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF BODY PAINS, CHILLS AND WEAKNESS. BLOOD CULTURES WERE DRAWN AND CAME BACK POSITIVE FOR SEPSIS. PLAINTIFF'S MEDICAL TEAM DETERMINED THE DEFECTIVE DEVICE CAUSED THE INFECTION AND NEEDED TO BE REMOVED. ON OR ABOUT (B)(6) 2021, PLAINTIFF'S SMARTPORT WAS REMOVED BY DR. (B)(6), M.D., AT (B)(6).

  Patient problems: Chills; Muscle Weakness/Atrophy; Pain; Sepsis

  MAUDE report 23086492 ↗
• MalfunctionSep 18, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT ON (B)(6) 2014, PLAINTIFF PRESENTED TO (B)(6), TO UNDERGO RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, WITH MODEL NUMBER: CT66LTPD. THIS SMARTPORT PRODUCT WAS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE ON (B)(6) 2014, IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. (B)(6), 1317056-2025-00255: EVENT 1) ON OR ABOUT ON (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF A NON-FUNCTIONAL SMARTPORT. UPON EVALUATION, PLAINTIFF WAS DIAGNOSED WITH A MALPOSITONED CATHETER AND FLIPPED PORT, REQUIRING REVISION OF THE SMARTPORT. THE ON (B)(6) 2015, REVISION PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. (B)(6): EVENT 2) ON OR ABOUT ON (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6), TO UNDERGO PARTIAL REMOVAL OF THE SMARTPORT AS SHE NO LONGER NEEDED TO USE THE PORT. UPON REMOVAL, PLAINTIFF'S MEDICAL TEAM LEARNED THAT THE SMARTPORT HAD FRACTURED AND DEVELOPED FIBRIN SHEATH. THE FRACTURED PORTION OF THE CATHETER COULD NOT BE REMOVED AND REMAINS IN PLAINTIFF'S BODY. THE REMOVAL PROCEDURE WAS PERFORMED BY DRS. (B)(6), M.D. ON OR ABOUT ON (B)(6) 2019, PLAINTIFF UNDERWENT A CHEST X-RAY, WHICH REVEALED A PORTION OF A RETAINED CATHETER OVERL

  Patient problems: Foreign Body In Patient

  MAUDE report 23083349 ↗
• MalfunctionSep 18, 2025Malposition of Device; Infusion or Flow Problem; Malposition of Device; Infusion or Flow Problem

  ON OR ABOUT ON (B)(6) 2014, PLAINTIFF PRESENTED TO (B)(6), TO UNDERGO RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, WITH MODEL NUMBER: CT66LTPD. THIS SMARTPORT PRODUCT WAS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE ON (B)(6) 2014, IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. (B)(6): EVENT 1) ON OR ABOUT ON (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF A NON-FUNCTIONAL SMARTPORT. UPON EVALUATION, PLAINTIFF WAS DIAGNOSED WITH A MALPOSITONED CATHETER AND FLIPPED PORT, REQUIRING REVISION OF THE SMARTPORT. THE ON (B)(6) 2015, REVISION PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. (B)(6), 1317056-2025-00256: EVENT 2) ON OR ABOUT ON (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), TO UNDERGO PARTIAL REMOVAL OF THE SMARTPORT AS SHE NO LONGER NEEDED TO USE THE PORT. UPON REMOVAL, PLAINTIFF'S MEDICAL TEAM LEARNED THAT THE SMARTPORT HAD FRACTURED AND DEVELOPED FIBRIN SHEATH. THE FRACTURED PORTION OF THE CATHETER COULD NOT BE REMOVED AND REMAINS IN PLAINTIFF'S BODY. THE REMOVAL PROCEDURE WAS PERFORMED BY DRS. (B)(6), M.D. ON OR ABOUT ON (B)(6) 2019, PLAINTIFF UNDERWENT A CHEST X-RAY, WHICH REVEALED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083348 ↗
• MalfunctionSep 17, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2014, PLAINTIFF (B)(6). UNDERWENT AN INSERTION OF A RIGHT INTERNAL JUGULAR VEIN CENTRAL VENOUS ACCESS PORT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT66LTPD, LOT NUMBER 599810. THE SMARTPORT WAS IMPLANTED AT (B)(6). PLAINTIFF AND HER HEALTH CARE PROVIDERS USED THE SMARTPORT IN A NORMAL, CUSTOMARY, INTENDED, AND FORESEEABLE MANNER, NAMELY AS A SURGICALLY PLACED DEVICE USED TO MAKE IT EASIER TO DELIVER MEDICATIONS DIRECTLY INTO THE PLAINTIFF'S BLOODSTREAM. MOREOVER, PLAINTIFF'S HEALTH CARE PROVIDERS DID NOT PLACE OR MAINTAIN THE DEVICE INCORRECTLY SUCH THAT IT CAUSED THE DEVICE TO "PINCH OFF" OR OTHERWISE MALFUNCTION. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL FOR REMOVAL AND REPLACEMENT OF HER SMARTPORT DEVICE. DURING THE COURSE OF THIS SURGERY, PLAINTIFF'S PHYSICIANS DISCOVERED A PORTION OF THE CATHETER FROM HER SMARTPORT DEVICE WAS FRACTURED AND/OR OTHERWISE UNREMOVABLE AND HAD TO BE LIGATED, TRANSECTED, AND PERMANENTLY LEFT IN HER BODY, THEREBY CAUSING HER ONGOING AND PERMANENT INJURIES. PLAINTIFF DID NOT SUFFER A JUDICIALLY COGNIZABLE INJURY AND HER CAUSE OF ACTION DID NOT ACCRUE UNTIL THIS (B)(6) 2019, REMOVAL OF

  Patient problems: Foreign Body In Patient

  MAUDE report 23073174 ↗
• InjuryJul 24, 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 PORT CATHETER PRODUCT, WITH MODEL NUMBER CT66LTPD, LOT NUMBER 5704812. THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6), FOR CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER, WITH SYMPTOMS OF AN INFECTION, SUBSEQUENTLY BEING DIAGNOSED WITH HAVING AN INFECTED PORT CATHETER THAT REQUIRED REMOVAL AND IN-HOSPITAL TREATMENT FOR THE INFECTION. THE REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2023 BY (B)(6), AT (B)(6) MEDICAL CENTER. FOLLOWING THE REMOVAL PROCEDURE ON (B)(6) 2023, PLAINTIFF WAS PRESCRIBED VANCOMYCIN, A STRONG ANTIBIOTIC, TO TREAT PLAINTIFF'S INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 22587631 ↗