Smart Port CT H787CT66LTPDVI1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15051684018098), received between Mar 14, 2025 and Apr 8, 2026 — classified as 1 death, 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  PRIOR TO ON (B)(6) 2023, THE PLAINTIFF WAS DIAGNOSED WITH COLON CANCER. THE TREATMENT FOR PLAINTIFF'S CANCER INCLUDED CHEMOTHERAPY. TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HIS PHYSICIANS HAD A PORT CATHETER PLACED IN HIM. ON OR ABOUT ON (B)(6) 2023, THE PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' PORT CATHETER, ALSO DESCRIBED AS SMARTPORT MODEL NO.: H787CT66LTPDVI1 MANUFACTURER: ANGIODYNAMICS, FOR THE PURPOSE OF PLAINTIFF'S CHEMOTHERAPY. ON OR ABOUT ON (B)(6) 2023, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) HOSPITAL FOR THE PURPOSES INDICATED ABOVE. THE DEFENDANTS, DIRECTLY OR THROUGH THEIR AGENTS, APPARENT AGENTS, SERVANTS, OR EMPLOYEES, DESIGNED, MANUFACTURED, MARKETED, ADVERTISED, DISTRIBUTED, AND SOLD THE PORT CATHETER THAT WAS IMPLANTED IN THE PLAINTIFF. ON OR ABOUT, ON (B)(6) 2023, PLAINTIFF WAS TAKEN TO (B)(6) HOSPITAL FOR A FEVER. HE WAS FOUND TO HAVE A PORT SITE INFECTION WITH ERYTHEMA AND PURULENT DRAINAGE FROM THE PORT SITE. TESTING AT THE HOSPITAL FOUND THE PORT CATHETER WOUND SITE TO BE GROWING STAPH AUREUS AND BACTEREMIA. HE WAS ADMITTED TO THE HOSPITAL AND WAS PLACED ON ANTIBIOTICS, HAD A FULL SEPSIS WORKUP, AND ON (B)(6) 2023,

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 24817765 ↗
• DeathMar 11, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2025, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT, WITH MODEL NUMBER: H787CT66LTPDVI1 AND LOT NUMBER: A4524037. THE SMARTPORT DEVICE WAS COMPROMISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR CHEMOTHERAPY TREATMENT. ON OR ABOUT ON (B)(6) 2025, DECEDENT PRESENTED TO (B)(6) WITH FATIGUE AND SHORTNESS OF BREATH. BLOOD CULTURES WERE DRAWN AND RETURNED POSITIVE FOR MRSA, NECESSITATING REMOVAL OF THE SMARTPORT. ON OR ABOUT ON (B)(6) 2025, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), M.D., AT (B)(6). ON OR ABOUT ON (B)(6) 2025, DECEDENT PASSED AWAY.

  Patient problems: Drug Resistant Bacterial Infection; Dyspnea; Fatigue

  MAUDE report 24573386 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED THE FOLLOWING EVENT, INVOLVING A CT LOW PROFILE WITH VALVED INTRODUCER SMARTPORT: "THE PATIENT IS HERE FOR A PORT REMOVAL BY DR [REDACTED]. UPON REMOVAL OF THE PORT, THE PORT AND PARTIAL CATHETER WAS RETRIEVED, AND THE REST OF THE CATHETER REMAINED IN THE CHEST SECONDARY TO THE CATHETER BREAKING OFF. DR. [REDACTED] ORDERED CHEST X-RAY TO VALIDATE THE POSITION OF THE REMNANT CATHETER. DR. [REDACTED] TALKED TO THE PARENT AND HE CAME BACK IN THE OR TO LET THE STAFF KNOW THAT HE IS CONSULTING IR [INTERVENTIONAL RADIOLOGY]. IR GOT CONSULTED THEN THEY DECIDED TO BRING THE PATIENT TO OR [REDACTED]. UPON FURTHER DELIBERATION AMONG SURGEONS, THEY DECIDED TO BRING THE PATIENT BACK TO CT. AFTER CT SCAN, WE TRANSPORTED THE PATIENT BACK TO OR [REDACTED] FOR INTERVENTION. PT AT HIGH RISK FOR CATHETER FRACTURE PER REPORT FROM SURGEON. CIRCULATOR INFORMED RSN [RENAL SUPPORT NURSE] OF FRACTURED CATHETER, RSN NOTIFIED PCM [PATIENT CARE MANAGER]. AT THIS POINT PCM ATTEMPTED TO DISCUSS THE CLINICAL PLAN. PROVIDER MENTIONED HE HAD REVIEWED THE RISK WITH PT'S FAMILY. DIRECTOR INFORMED SURGEON OF DISCLOSURE AND DOCUMENTATION NEEDS. SURGEON RETURNED TO OR TO CONSULT WITH IR REGARDING

  Patient problems: Foreign Body In Patient

  MAUDE report 23405198 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN ASSISTANT REPORTED THAT A PATIENT'S CT LOW PROFILE WITH VALVED INTRODUCER SMARTPORT REQUIRED REMOVAL DUE TO AN INFECTION. THE PATIENT'S PORT POCKET SITE WAS REPORTED AS "RED, INDURATED WITH PURULENT DRAINAGE."

  Patient problems: Medical device site infection; Purulent Discharge; Skin Discoloration

  MAUDE report 23404455 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN ASSISTANT REPORTED THAT A PATIENT'S CT LOW PROFILE WITH VALVED INTRODUCER SMARTPORT REQUIRED REMOVAL AND REPLACEMENT DUE TO AN INFECTION. THE PORT POCKET WAS PURULENT, AND PATIENT HAS BEEN STARTED ON ORAL ANTIBIOTICS. THE PATIENT HAS NO KNOWN ALLERGIES, INCLUDING TO METALS, AND THE PORT WAS PLACED USING REPROCESSED SURGICAL EQUIPMENT.

  Patient problems: Medical device site infection; Purulent Discharge

  MAUDE report 23327816 ↗
• InjurySep 15, 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 H787CT66LTPDVI1, AND LOT NUMBER UNKNOWN. THIS SMARTPORT DEVICES CONSISTED OF A PORT BODY AND A POLYURETHANE CATHETER. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6), WITH COMPLAINTS OF A FEVER. BLOOD CULTURES WERE DRAWN FROM THE SMARTPORT AND CAME BACK POSITIVE FOR AN INFECTION, WHICH WOULD REQUIRE REMOVAL OF THE SMARTPORT. ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT REMOVAL OF THE INFECTED SMARTPORT. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. AT (B)(6).

  Patient problems: Fever; Unspecified Infection

  MAUDE report 23054794 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO (B)(6) 2021, PLAINTIFF ((B)(6)) WAS DIAGNOSED WITH CERVICAL CANCER. THE TREATMENT FOR PLAINTIFF'S 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' ''SMART PORT", IDENTIFIED BY THE FOLLOWING: UPN H787CT66LTPDVII, LOT: 5658364, TL282101 F, (B)(6), FOR THE PURPOSES OF PLAINTIFFS CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021, THE DEVICE AT ISSUE REFERENCED ABOVE WAS IMPLANTED BY DR. (B)(6), AT (B)(6) FOR THE PURPOSES INDICATED ABOVE. THE DEFENDANTS, DIRECTLY OR THROUGH THEIR AGENTS, APPARENT AGENTS, SERVANTS, OR EMPLOYEES, DESIGNED, MANUFACTURED, MARKETED, ADVERTISED, DISTRIBUTED, AND SOLD THE SMART PORT THAT WAS IMPLANTED IN S.B. THEREAFTER, THE PLAINTIFF DEVELOPED AN INFECTION AS DIAGNOSED BY HER HEALTH CARE PROVIDERS, DEVELOPED AN ABSCESS THAT REQUIRED MEDICAL TREATMENT, AND DEVELOPED AND WAS DIAGNOSED WITH MRSA BACTEREMIA. THE PLAINTIFF RECEIVED MEDICAL CARE AND TREATMENT FOR THE ABOVE MEDICAL CONDITIONS. ON OR ABOUT (B)(6) 2021, THE PLAINTIFF'S SMART PORT, PORT-A-CATH AT ISSUE WAS REMOVED DUE TO

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22893842 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT LEFT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT CT SINGLE TITANIUM PORT CATHETER PRODUCT, WITH MODEL NUMBER H787CT66LTPDVI1, AND LOT NUMBER 5676712. THE SMARTPORT WAS IMPLANTED DR. (B)(6), M.D., (B)(6). ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED (B)(6) WITH COMPLAINTS OF ALTERED MENTAL STATUS AND WAS FOUND TO HAVE SEPSIS METABOLIC ENCEPHALOPATHY AND POSITIVE BLOOD CULTURES FOR INFECTION. ON OR ABOUT (B)(6) 2022, PLAINTIFF, WHILE HOSPITALIZED (B)(6), UNDERWENT REMOVAL OF THE INFECTED AND DEFECTIVE SMARTPORT, AND THE PROCEDURE WAS PERFORMED BY (B)(6), M.D. DURING THE REMOVAL PROCEDURE, DR. (B)(6) NOTED PURULENCE WITHIN THE PORT POCKET, AND BLOOD DRAWN FROM THE PORT WAS POSITIVE FOR BACTEREMIA.

  Patient problems: Altered State of Consciousness; Bacteremia; Encephalopathy; Sepsis

  MAUDE report 22556566 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED AN ISSUE DURING REMOVAL OF A CT LOW PROFILE WITH VALVED INTRODUCER SMARTPORT. UPON DEVICE REMOVAL, THE PHYSICIAN DISCOVERED THAT THE CATHETER COULD NOT BE REMOVED AS IT WAS STUCK TO THE PATIENT'S VESSEL. DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22159121 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5585461. THE DEVICE WAS IMPLANTED BY DR. (B)(6), FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6), WITH COMPLAINTS OF FEVER AND BILATERIAL HIP PAIN. BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR ESCHERICHIA COLI. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT SHE SHOULD BE ADMITTED TO (B)(6) AND PRESCRIBED ANTIBIOTICS. HER HIP PAIN WAS DETERMINED TO BE UNRELATED TO THE INFECTION. THE INFECTION IMPROVED OVER THE NEXT FIVE DAYS AND PLAINTIFF WAS DISCHARGED ON (B)(6) 2021, WITH INSTRUCTIONS TO RETURN TO THE HOSPITAL SHOULD HER SYMPTOMS REAPPEAR. ((B)(4)- 1317056-2025-00083). ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) WITH COMPLAINTS OF A FEVER AND A SUSPECTED INFECTION DUE TO HER SMARTPORT. HER MEDICAL TEAM PRESCRIBED ANTIBIOTICS TO TREAT A BACTERIAL INFECTION. IN THE EVENING OF (B)(6) 2023, WHEN HER SYMPTOMS CONTINUED, SHE PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6). PLAINTIFF'S MEDICAL TEAM

  Patient problems: Fever; Sepsis

  MAUDE report 21679031 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5585461. THE DEVICE WAS IMPLANTED BY DR. (B)(6), FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6), WITH COMPLAINTS OF FEVER AND BILATERIAL HIP PAIN. BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR ESCHERICHIA COLI. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT SHE SHOULD BE ADMITTED TO (B)(6) AND PRESCRIBED ANTIBIOTICS. HER HIP PAIN WAS DETERMINED TO BE UNRELATED TO THE INFECTION. THE INFECTION IMPROVED OVER THE NEXT FIVE DAYS AND PLAINTIFF WAS DISCHARGED ON (B)(6) 2021, WITH INSTRUCTIONS TO RETURN TO THE HOSPITAL SHOULD HER SYMPTOMS REAPPEAR. ((B)(4)- 1317056-2025-00083). ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO TAMPA GUIDEWELL EMERGENCY DOCTORS WITH COMPLAINTS OF A FEVER AND A SUSPECTED INFECTION DUE TO HER SMARTPORT. HER MEDICAL TEAM PRESCRIBED ANTIBIOTICS TO TREAT A BACTERIAL INFECTION. IN THE EVENING OF (B)(6) 2023, WHEN HER SYMPTOMS CONTINUED, SHE PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6

  Patient problems: Fever; Unspecified Infection

  MAUDE report 21678640 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT ON (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: H787CT66LTPDVI1, LOT NUMBER: 5585461. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6), FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6), WITH COMPLAINTS OF FEVER AND BILATERIAL HIP PAIN. BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR ESCHERICHIA COLI. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT SHE SHOULD BE ADMITTED TO (B)(6) AND PRESCRIBED ANTIBIOTICS. HER HIP PAIN WAS DETERMINED TO BE UNRELATED TO THE INFECTION. THE INFECTION IMPROVED OVER THE NEXT FIVE DAYS AND PLAINTIFF WAS DISCHARGED ON (B)(6) 2021, WITH INSTRUCTIONS TO RETURN TO THE HOSPITAL SHOULD HER SYMPTOMS REAPPEAR. (B)(4). ON OR ABOUT ON (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) EMERGENCY DOCTORS WITH COMPLAINTS OF A FEVER AND A SUSPECTED INFECTION DUE TO HER SMARTPORT. HER MEDICAL TEAM PRESCRIBED ANTIBIOTICS TO TREAT A BACTERIAL INFECTION. IN THE EVENING OF ON (B)(6) 2023, WHEN HER SYMPTOMS CONTINUED, SHE PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT

  Patient problems: Bacterial Infection

  MAUDE report 21678636 ↗
• InjuryMar 14, 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 THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, REFERENCE NUMBER: (B)(4), LOT NUMBER: 5733001. THE DEVICE WAS IMPLANTED AT (B)(6) MEDICAL CENTER FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HERSELF TO (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21606465 ↗