Smart Port CT H787CT96STSD0Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 15051684018067), received between Mar 13, 2025 and Aug 11, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Obstruction of Flow

  On or about (b)(6) 2016, 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 CT96STSD, lot number 4987773. Upon information and belief, this SmartPort device consisted of a port body and a silicone catheter. The SmartPort was implanted at (b)(6). On or about (b)(6) 2016, Plaintiff presented to (b)(6) Hospital in (b)(6) for right arm swelling and discomfort, where she was ultimately diagnosed with right upper extremity deep vein thrombosis ("DVT") caused by her SmartPort device. Her treaters did not recommend removal of the device at that time, and instead Plaintiff was treated by being placed on blood thinners for 6 months. Thereafter, the SmartPort device remained implanted, and Plaintiff did not suffer further problems until on or about (b)(6) 2019, when she presented to Lake Regional Hospital for right chest and neck pain caused by her Smart Port device, which was occluded and not working properly. Her SmartPort device was thereafter surgically removed on or about (b)(6) 2019, at (b)(6) Hospital.

  Patient problems: Chest Pain; Discomfort; Neck Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 50201616 ↗
• MalfunctionMar 24, 2026Complete Blockage

  ON OR ABOUT (B)(6) 2014, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN, WITH MODEL NUMBER CT96STSD, AND LOT NUMBER 4812637. THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE SMARTPORT DEVICE WAS IMPLANTED BY DR. (B)(6), AT THE (B)(6) MEDICAL CENTER IN (B)(6). THE PURPOSE OF IMPLANTATION OF THE SMARTPORT WAS TO ADMINISTER IV MEDICATION TO TREAT LEUKEMIA. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO THE (B)(6) MEDICAL CENTER IN (B)(6), DUE TO DYSFUNCTION OF HER PORT DEVICE. IMAGING PERFORMED AT THE FACILITY DETERMINED THAT A FIBRINOUS SHEATH HAD FORMED AT THE TIP OF THE DEVICE, NECESSITATING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678415 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, LOT NUMBER 5430649 REFERENCE NUMBER H787CT96STSD0. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6) MEDICAL CENTER IN (B)(6), FOR BREAST CANCER TREATMENT. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), WHERE HIS IMPLANTED PORT WAS REMOVED DUE TO INFECTION. THE PLAINTIFF WAS DIAGNOSED WITH BACTEREMIA.

  Patient problems: Bacterial Infection

  MAUDE report 24673861 ↗
• InjuryMar 23, 2026Obstruction of Flow

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PORT REPLACEMENT. THE SMARTPORT DEVICE WAS REPLACED BY DR. (B)(6), M.D., AT THE (B)(6) IN (B)(6). THE NEW SMARTPORT HAD MODEL NUMBER H787CT96STSD0 AND LOT NUMBER 5728569. THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO SISTERS OF (B)(6) HOSPITAL IN (B)(6), DUE TO DYSFUNCTION OF HER PORT DEVICE. IMAGING PERFORMED AT THE FACILITY DETERMINED THAT SHE HAD AN OCCLUDED LEFT BRACHIOCEPHALIC VEIN AND SUPERIOR VENA CAVA, NECESSITATING REMOVAL OF THE DEVICE. ON (B)(6) 2023, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), M.D., AT SISTERS OF (B)(6) HOSPITAL IN (B)(6).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24671268 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, M.B. UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMART PORT CT DEVICE, CATALOG # CT96STSD, LOT # 508023. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 9.6F X 66CM SILICONE CATHETER AND 10 F INTRODUCER KIT. THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6) FOR THE CHEMOTHERAPY TREATMENT OF PLAINTIFF'S METASTATIC OVARIAN CANCER. ON OR AROUND (B)(6) 2010, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6). ON OR AROUND (B)(6) 2010, PLAINTIFF WAS TRANSFERRED TO THE OR AT (B)(6) HOSPITAL AFTER IT WAS DETERMINED BY PLAINTIFF'S MEDICAL TEAM THAT HER PORT WAS INFECTED AND NEEDED TO BE REMOVED. PLAINTIFF'S INFECTED SMART PORT CT WAS THEN REMOVED BY DR. (B)(6), MD. AFTER REMOVAL OF THE DEFECTIVE SMART PORT 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. PLAINTIFF KNEW SHE HAD AN INFECTION, BUT SHE DID NOT KNOW HER INFECTION WAS CAUSED BY THE SMART PORT CT'S DEFECTS AND/OR BY THE DEFENDANTS' CONDUCT. PLAINTIFF DID NOT DISCOVER THE HEIGHTENED RISK OF INFECTION RELATED TO THE SMART PORT C

  Patient problems: Unspecified Infection

  MAUDE report 23827435 ↗
• InjuryOct 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR THE PURPOSE OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED HIMSELF TO (B)(6) WHERE HIS PORT WAS SUBSEQUENTLY REMOVED DUE TO PAIN AND THROMBOSIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 23387868 ↗
• MalfunctionSep 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: CT96STSD; LOT NUMBER: 4833030. THE DEVICE WAS IMPLANTED BY DR. (B)(6), AT (B)(6), FOR THE PURPOSE OF PROVIDING VENOUS ACCESS AND FOR MEDICATIONS TO TREAT HER CROHN'S DISEASE. (PORT 1 REVISION) UPON INFORMATION AND BELIEF, ON (B)(6) 2016, DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR PLAINTIFF WAS "POOR VENOUS ACCESS AND NEED FOR PORT-A-CATH WITH A MALPOSITIONED PORT". DR. (B)(6) PROCEEDED TO PERFORM A REVISION/REPLACEMENT OF THE PREVIOUSLY PLACED SMARTPORT. HOWEVER, ONLY THE PORT HUB WAS REMOVED AND REPLACED WITH A NEW PORT HUB. THE PREVIOUSLY PLACED SMARTPORT CATHETER REMAINED. SURGERY WAS DONE AT (B)(6). (B)(4), 1317056-2025-00245) . (PORT 1 REMOVAL, PORT 2 PLACEMENT) ON (B)(6) 2017, DR. (B)(6) REMOVED THE PREVIOUS PORTACATH AND CATHETER AND IMPLANTED A NEW SMARTPORT WITH REFERENCE NUMBER: CT96STSD; LOT NUMBER: 5089596. THIS SURGERY WAS PERFORMED AT (B)(6). DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR S.R. WAS "POOR VENOUS ACCESS WITH POORLY FUNCTIONING PORT-A-CATH". (B)(4), 1317056-2025-00246). (PORT 2 REMOVAL, PORT 3 PLACEMENT+) ON (B)(6) 2018, DR. (B)(6) REMOVED THE SMARTPORT AND I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090608 ↗
• MalfunctionSep 18, 2025Malposition of Device; Infusion or Flow Problem; Malposition of Device; Infusion or Flow Problem

  ON OR ABOUT ON (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: CT96STSD; LOT NUMBER: 4833030. THE DEVICE WAS IMPLANTED BY DR. (B)(6), FOR THE PURPOSE OF PROVIDING VENOUS ACCESS AND FOR MEDICATIONS TO TREAT HER CROHN'S DISEASE. (PORT 1 REVISION) UPON INFORMATION AND BELIEF, ON (B)(6) 2016, DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR PLAINTIFF WAS "POOR VENOUS ACCESS AND NEED FOR PORT-A-CATH WITH A MALPOSITIONED PORT". DR. (B)(6) PROCEEDED TO PERFORM A REVISION/REPLACEMENT OF THE PREVIOUSLY PLACED SMARTPORT. HOWEVER, ONLY THE PORT HUB WAS REMOVED AND REPLACED WITH A NEW PORT HUB. THE PREVIOUSLY PLACED SMARTPORT CATHETER REMAINED. SURGERY WAS DONE AT (B)(6). (B)(6). (PORT 1 REMOVAL, PORT 2 PLACEMENT) ON (B)(6) 2017, DR. (B)(6) REMOVED THE PREVIOUS PORTACATH AND CATHETER AND IMPLANTED A NEW SMARTPORT WITH REFERENCE NUMBER: CT96STSD; LOT NUMBER: 5089596. THIS SURGERY WAS PERFORMED AT (B)(6). DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR (B)(6). WAS "POOR VENOUS ACCESS WITH POORLY FUNCTIONING PORT-A-CATH". (B)(6), 1317056-2025-00246) (PORT 2 REMOVAL, PORT 3 PLACEMENT+) ON (B)(6) 2018, DR. (B)(6) REMOVED THE SMARTPORT AND IMPLANTED ANOTHER NEW SMARTPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090604 ↗
• MalfunctionSep 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: (B)(4); LOT NUMBER: 4833030. THE DEVICE WAS IMPLANTED BY DR. (B)(6), AT (B)(6) MEDICAL CENTER IN SARANAC LAKE, NEW YORK, FOR THE PURPOSE OF PROVIDING VENOUS ACCESS AND FOR MEDICATIONS TO TREAT HER CROHN'S DISEASE. (PORT 1 REVISION) UPON INFORMATION AND BELIEF, ON (B)(6) 2016, DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR PLAINTIFF WAS "POOR VENOUS ACCESS AND NEED FOR PORT-A-CATH WITH A MALPOSITIONED PORT". DR. (B)(6) PROCEEDED TO PERFORM A REVISION/REPLACEMENT OF THE PREVIOUSLY PLACED SMARTPORT. HOWEVER, ONLY THE PORT HUB WAS REMOVED AND REPLACED WITH A NEW PORT HUB. THE PREVIOUSLY PLACED SMARTPORT CATHETER REMAINED. SURGERY WAS DONE AT (B)(6) MEDICAL CENTER IN SARANAC LAKE, NEW YORK. ((B)(4), 1317056-2025-00245). (PORT 1 REMOVAL, PORT 2 PLACEMENT) ON (B)(6) 2017, DR. (B)(6) REMOVED THE PREVIOUS PORTACATH AND CATHETER AND IMPLANTED A NEW SMARTPORT WITH REFERENCE NUMBER: (B)(4); LOT NUMBER: 5089596. THIS SURGERY WAS PERFORMED AT (B)(6) MEDICAL CENTER IN SARANAC LAKE, NEW YORK. DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR S.R. WAS "POOR VENOUS ACCESS WITH POORLY FUNCTIONING PORT-A-CATH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090596 ↗
• MalfunctionSep 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ON OR (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: CT96STSD; LOT NUMBER: 4833030. THE DEVICE WAS IMPLANTED BY DR. (B)(6), AT (B)(6) MEDICAL CENTER IN (B)(6), FOR THE PURPOSE OF PROVIDING VENOUS ACCESS AND FOR MEDICATIONS TO TREAT HER CROHN'S DISEASE. (PORT 1 REVISION) UPON INFORMATION AND BELIEF, ON (B)(6) 2016, DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR PLAINTIFF WAS "POOR VENOUS ACCESS AND NEED FOR PORT-A-CATH WITH A MALPOSITIONED PORT". DR. (B)(4) PROCEEDED TO PERFORM A REVISION/REPLACEMENT OF THE PREVIOUSLY PLACED SMARTPORT. HOWEVER, ONLY THE PORT HUB WAS REMOVED AND REPLACED WITH A NEW PORT HUB. THE PREVIOUSLY PLACED SMARTPORT CATHETER REMAINED. SURGERY WAS DONE AT (B)(6) MEDICAL CENTER IN (B)(6). ((B)(4), 1317056-2025-00245). (PORT 1 REMOVAL, PORT 2 PLACEMENT) ON (B)(6) 2017, DR. (B)(6) REMOVED THE PREVIOUS PORTACATH AND CATHETER AND IMPLANTED A NEW SMARTPORT WITH REFERENCE NUMBER: CT96STSD; LOT NUMBER: 5089596. THIS SURGERY WAS PERFORMED AT (B)(6) MEDICAL CENTER IN (B)(6). DR. (B)(6) PREOPERATIVE DIAGNOSIS FOR S.R. WAS "POOR VENOUS ACCESS WITH POORLY FUNCTIONING PORT-A-CATH". ((B)(4), 1317056-2025-00246). (PORT 2 REMOVAL, POR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090595 ↗
• MalfunctionSep 17, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), TO UNDERGO RIGHT SUBCLAVIAN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, WITH MODEL NUMBER H787CT96STSD0, AND LOT NUMBER 5671716. THIS SMARTPORT PRODUCT IS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE SMARTPORT IMPLANT PROCEDURE WAS PERFORMED BY DR. (B)(6) M.D. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), AFTER AN X-RAY REVEALED THE CATHETER PORTION OF THE IMPLANTED SMARTPORT DEVICE HAD FRACTURED. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WOULD NEED TO BE REMOVED. ON OR ABOUT (B)(6) 2022, WHILE STILL HOSPITALIZED AT (B)(6) HOSPITAL IN (B)(6), DR. (B)(6) M.D., ATTEMPTED TO REMOVE THE DEFECT SMARTPORT DEVICE BUT WAS UNSUCCESSFUL. A BROKEN CATHETER FRAGMENT COULD NOT BE REMOVED AND REMAINS IN THE LOWER RIGHT LOBE OF PLAINTIFF'S PULMONARY ARTERY. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), FOR A SECOND ATTEMPT AT REMOVAL OF THE RETAINED CATHETER FRAGMENT, WHICH WAS PERFORMED BY DR. (B)(6), M.D., WHICH WAS UNSUCCESSFUL, AND THE FRACTURED CATHETER FRAGMENT REMAINS IN PLAINTIFF'S BODY TODAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23080604 ↗
• InjurySep 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH AN UNKNOWN MODEL NUMBER, AND LOT NUMBER 5225956. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D, AT (B)(6) HOSPITAL. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL, WITH COMPLAINTS OF NAUSEA, VOMITING, AND DIARRHEA, AND REPORTING TWO SYNCOPAL EPISODES. AFTER UNDERGOING BLOOD WORK, PLAINTIFF WAS DIAGNOSED WITH SEPSIS DUE INFECTION ORIGINATING FROM THE SMARTPORT, REQUIRING REMOVAL OF THE DEVICE. ON OR ABOUT (B)(6) 2018, WHILE ADMITTED AT (B)(6) HOSPITAL, PLAINTIFF UNDERWENT REMOVAL OF HER INFECTED SMARTPORT. THE PROCEDURE WAS PERFORMED BY (B)(6), M.D. PLAINTIFF REMAINED HOSPITALIZED FOR TREATMENT UNTIL (B)(6) 2018, WHEN SHE WAS DISCHARGED.

  Patient problems: Bacterial Infection; Diarrhea; Nausea; Sepsis; Syncope/Fainting; Vomiting

  MAUDE report 23048130 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2021, PLAINTIFF (B)(6) UNDERWENT AN INSERTION OF RIGHT SUBCLAVIAN TUNNELED CENTRAL VENOUS ACCESS PORT OF AN ANGIODYNAMICS SMARTPORT CT PORT CATHETER PRODUCT, MODEL NUMBER H787CT96STSD0, LOT NUMBER 5671717. THE SMARTPORT WAS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6). ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) AT THE UNIVERSITY OF (B)(6) LOCATED IN (B)(6) FOR ACUTE ENCEPHALOPATHY AND WAS DIAGNOSED WITH SERIOUS INFECTIONS, INCLUDING, SEPSIS - SEPTIC SHOCK - STAPH BACTEREMIA, AND C/F ENDOCARDITIS, RESULTING IN THE SURGICAL REMOVAL OF THE SMARTPORT DEFECTIVE DEVICE ON (B)(6) 2023.

  Patient problems: Bacteremia; Encephalopathy; Endocarditis; Sepsis; Septic Shock

  MAUDE report 22172705 ↗
• InjuryMay 22, 2025Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2009, PLAINTIFF UNDERWENT IMPLANTATION OF A LEFT SUBCLAVIAN ANGIODYNAMICS SMARTPORT, MODEL NUMBER CT96STSD, LOT NUMBER 978460. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) MEDICAL CENTER IN (B)(6). ON OR ABOUT (B)(6) 2010, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER FOR REMOVAL OF THE PORT, PERFORMED BY DR. (B)(6), M.D. DURING THE PROCEDURE, PLAINTIFF'S MEDICAL TEAM DISCOVERED THAT THE CATHETER HAD FRACTURED. A CHEST X-RAY REVELAED THAT THE CATHETER HAD MIGRATED TO PLAINTIFF'S INNOMINATE VEIN AND RIGHT HEART. ON OR ABOUT (B)(6) 2010, PLAINTIFF UNDERWENT A PROCEDURE TO REMOVE THE RETAINED CATHETER FRAGMENT, PERFORMED BY DR. (B)(6), M.D. THE FRAGMENT WAS LOCATED IN THE LEFT SUBCLAVIAN AND LEFT BRACHIOCEPHALIC VEINS, AS WELL AS THE RIGHT VEIN. ON OR ABOUT (B)(6) 2010, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER, WHERE IMAGING PERFORMED BY DR. (B)(6), M.D., REVEALED THAT SHE HAD DEVELOPED A PULMONARY EMBOLISM.

  Patient problems: Foreign Body In Patient; Pulmonary Embolism

  MAUDE report 22072809 ↗
• InjuryMay 7, 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 PORT CATHETER PRODUCT, MODEL NUMBER H787CT96STD0, LOT NUMBER 5528068. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6). ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF FEVER, CHILLS, NAUSEA, VOMITING, BACK PAIN, AND HEADACHE. BLOOD CULTURES WERE OBTAINED, HER MEDICAL TEAM DETERMINED THAT SHE HAD DEVELOPED SEVERE SEPSIS AND ENTEROBACTER BACTEREMIA, WITH THE SMARTPORT IDENTIFIED AS THE SOURCE. ON OR ABOUT (B)(6) 2020, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), M.D., (B)(6).

  Patient problems: Back pain; Bacteremia; Chills; Fever; Headache; Nausea; Sepsis; Vomiting

  MAUDE report 21981962 ↗
• InjuryApr 22, 2025Obstruction of Flow; Obstruction of Flow

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, LOT NUMBER 4777969. THE DEVICE WAS IMPLANTED BY (B)(6), MD , AT (B)(6) , FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED HIMSELF TO (B)(6) WHERE HIS PORT WAS REMOVED DUE TO CAUSING BLOOD CLOTS AND AN OCCLUSION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21883517 ↗
• InjuryMar 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT(B)(6) 2019, DECEDENT UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, REFERENCE NUMBER (B)(6), LOT NUMBER 5430649. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6) MEDICAL CENTER, (B)(6), TEXAS, FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2019, DECEDENT PRESENTED HERSELF TO (B)(6) MEDICAL CENTER, (B)(6), TEXAS WHERE HER PORT WAS SUBSEQUENTLY REMOVED AS IT CAUSED AN EMBOLISM.

  Patient problems: Embolism/Embolus

  MAUDE report 21674524 ↗
• InjuryMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2012, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT POWER INJECTABLE PORT, CATALOG NUMBER CT96STSD. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2012, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL IN (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO BREAKAGE THAT CAUSED BLOOD CLOTS. DURING THE REMOVAL PROCEDURE, THEY WERE UNABLE TO REMOVE THE ENTIRE DEVICE.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 21606846 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER H787CT96STSD0, BY DR. (B)(6), M.D. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6), WHERE IMAGING REVEALED THAT SHE HAD DEVELOPED A THROMBOSIS AND STENOSIS RELATED TO HER ANGIODYNAMICS SMARTPORT CATHETER PRODUCT, MODEL NUMBER H787CT96STSD0. ON OR ABOUT (B)(6) 2019, PLAINTIFF PRESENTED TO (B)(6) FOR PORT REMOVAL DUE TO RECURRING THROMBOSIS. THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), M.D.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 21593283 ↗
• MalfunctionMar 13, 2025Fracture; Fracture

  ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER H787CT96STSD0, LOT NUMBER 5078406. THE SMARTPORT WAS IMPLANTED BY DR.(B)(6), M.D, (B)(6) MEDICAL CENTER IN (B)(6) . ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER FOR AN INFUSION. DURING THE INFUSION, PLAINTIFF EXPERIENCED NECK SWELLING AND UNDERWENT A PORT STUDY. THE STUDY DEMONSTRATED EXTRAVASATION OF CONTRAST AROUND THE NECK AREA. THE DEFECTIVE DEVICE WAS REPLACED WITH AN ANGIODYNAMICS SMARTPORT CATHETER PRODUCT, BY DR. (B)(6), M.D.

  Patient problems: Swelling/ Edema

  MAUDE report 21592298 ↗

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