Smart Port CT CT96STSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI H787CT96STSD0), received between Mar 6, 2017 and Jan 14, 2025 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2010, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT CT PRODUCT, CATALOG NUMBER CT96STSD. 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. UPON INFORMATION AND BELIEF, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD., AT (B)(6) HOSPITAL, IN (B)(6), FOR LONG-TERM VENOUS ACCESS FOR PLAINTIFF'S MEDICAL CONDITION. ON OR ABOUT (B)(6) 2010, PLAINTIFF'S PORT-A-CATH AT ISSUE WAS SCHEDULED FOR REMOVAL. ON OR ABOUT (B)(6) 2010, DR. (B)(6), M.D. REMOVED PLAINTIFF'S PORT-A-CATH AT ISSUE, AS THE PRE-OP DIAGNOSIS INDICATED THAT PLAINTIFF'S PORT-A-CATH BECAME INFECTED WHILE BEING IMPLANTED. UPON INFORMATION AND BELIEF, THE REMOVAL PROCEDURE IN QUESTION TOOK PLACE AT (B)(6) HOSPITAL, IN (B)(6). UPON THE REMOVAL OF PLAINTIFF'S PORT-A-CATH, IT WAS DETERMINED THAT PLAINTIFF'S PORTA- CATH AT ISSUE WAS INDEED INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 21150456 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OR ABOUT ON (B)(6) 2020, PLAINTIFF UNDERWENT LEFT SUBCLAVIAN PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT AT (B)(6), BY DR. (B)(6) M.D. THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING IV CHEMOTHERAPY TO TREAT BREAST CANCER. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF PRESENT TO (B)(6), FOR A PORT FLUSH, WHICH WAS UNSUCCESSFUL AND CAUSED PLAINTIFF TO EXPERIENCE PAIN AND RESISTANCE. PLAINTIFF'S ONCOLOGIST, DR. (B)(6) M.D., INDICATED THAT THE SMARTPORT WAS NO LONGER FUNCTIONAL. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6), FOR REMOVAL OF THE SMARTPORT, PERFORMED BY (B)(6) M.D. UPON REMOVAL, THE PHYSICIAN NOTED THAT THE CATHETER APPEARED TO BE BROKEN, AND ONLY 10CM OF THE CATHETER WAS REMOVED. PLAINTIFF WAS LATER SENT TO UNDERGO AN X-RAY TO INVESTIGATE THE FRACTURED CATHETER. REVIEW OF THE X-RAY BY DR. (B)(6) M.D., A RADIOLOGIST, INDICATED THAT THE MISSING 9CM SEGMENT OF THE CATHETER IS OBLIQUELY ORIENTED ACROSS THE RIGHT ASPECT OF THE CARDIAC SILHOUETTE. ON OR ABOUT ON (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6), FOR REMOVAL OF THE MISSING CATHETER FRAGMENT, WHICH WAS WITHIN THE RIGHT HEART. THE PROCEDURE WAS PERFORMED BY DR. (B)(6) M.D., AND HE NOTED THAT BOTH ENDS OF

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 21103206 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON OR ABOUT (B)(6) 2014, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER: CT96STSD AND LOT NUMBER: 4790165. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) HOSPITAL (B)(6), TO FACILITATE FREQUENT IV ACCESS. ON OR ABOUT (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER (B)(6), FOR A PORT CHECK. THE CHECK REVEALED THAT THE CATHETER HAD FRACTURED AND WAS LEAKING NEAR PLAINTIFF'S UPPER RIGHT NECK. ON OR ABOUT (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER (B)(6) FOR PORT REMOVAL. THE DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), M.D. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE CORRECTIVE SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925201 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT, REFERENCE NUMBER (B)(4), LOT NUMBER 4891715. THE DEVICE WAS IMPLANTED BY (B)(6), AT PACIFIC INTERVENTIONAL VASCULAR ACCESS CENTER IN CULVER CITY, CALIFORNIA, FOR THE PURPOSE OF ONGOING TREATMENT FOR HER SYSTEMIC SCLERODERMA. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED HERSELF TO (B)(6), IN (B)(6), CALIFORNIA WHERE SHE WAS ADMITTED TO THE HOSPITAL DUE TO AN INFECTION. PLAINTIFF'S DOCTORS ULTIMATELY REMOVED THE PORT AND TREATED THE INFECTION WITH INTRA VENOUS ANTIBIOTICS. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Bacterial Infection

  MAUDE report 20905867 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, A SMART PORT DEVICE WAS SURGICALLY IMPLANTED INTO PLAINTIFF, REFERENCE NUMBER (B)(4), LOT NUMBER 5741965. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER WITH COMPLAINTS OF SHORTNESS OF BREATH AND CHEST PAIN. PLAINTIFF WAS DIAGNOSED WITH A PULMONARY EMBOLISM AND BACTEREMIA SECONDARY TO AN INFECTED RIGHT SUBCLAVIAN VENOUS ACCESS DEVICE. ON OR ABOUT (B)(6) 2022, DR. (B)(6) SURGICALLY REMOVED THE DEVICE FROM THE PLAINTIFF.

  Patient problems: Bacteremia; Bacterial Infection; Chest Pain; Pulmonary Embolism

  MAUDE report 20711984 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, THE DEVICE WAS SURGICALLY IMPLANTED INTO PLAINTIFF, REFERENCE NUMBER (B)(4), LOT NUMBER 5569101. THE DEVICE WAS IMPLANTED BY DR. (B)(6) FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY TREATMENT DUE TO PLAINTIFF'S CECAL CANCER. DEVICE WAS CORRECTLY AND PROPERLY INSTALLED BY DR. (B)(6), IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS. THE DEVICE WAS NOT IMPLANTED IN SUCH A MANNER THAT WOULD HAVE CAUSED IT TO COMPRESS, ERODE OR "PINCH OFF," ON OR ABOUT (B)(6) 2021, DR. (B)(6) SURGICALLY REMOVED THE DEVICE FROM PLAINTIFF DUE TO INFECTION ASSOCIATED WITH THE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 20710418 ↗
• MalfunctionNov 18, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT, CATALOG NUMBER CT96STSD, LOT NUMBER 5089596. THE DEVICE WAS IMPLANTED BY DR. S. REID, AT RICHLAND MEMORIAL HOSPITAL, IN OLNEY, ILLINOIS, FOR THE PURPOSE OF ONGOING TREATMENT FOR HER LUPUS. ON OR ABOUT (B)(6) 2022, PLAINTIFF'S PORT MALFUNCTIONED AND IT WAS DETERMINED IT MUST BE REMOVED. UNFORTUNATELY, THE PORT FRACTURED AND COULD NOT BE FULLY REMOVED FROM HER BODY; LEAVING PART OF THE DEVICE IN SITU. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20707930 ↗
• MalfunctionOct 20, 2024Material Rupture; Migration; Material Rupture; Migration

  ON OR ABOUT (B)(6) 2014, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL/CAT NUMBER H787CT96STSD0, LOT NUMBER 4774517 UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMARTPORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 9.6 F SILICONE CATHETER. UPON INFORMATION AND BELIEF, THE DEVICE AT ISSUE IS ALSO KNOWN AS TITANIUM/SILICONE FLUOROMAX 9.6F DETACHED SILICONE CATHETER. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT, (B)(6) HOSPITAL, (B)(6), FOR CHEMOTHERAPY TREATMENT FOR LUNG CANCER. ON OR ABOUT(B)(6) 2015, PLAINTIFF (B)(6) BROUGHT HER HUSBAND (B)(6), TO (B)(6) HEALTH CENTER IN (B)(6), AFTER IMAGING CONFIRMED COMPLETELY RUPTURED CATHETER WITH THE MID TO DISTAL ASPECT OF SAID CATHETER LOOSE WITHIN THE RIGHT ATRIUM. AFTER ADDITIONAL TESTING, (B)(6)'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS CONFIRMED TO BE RUPTURED AND THAT THE DEFECTIVE PORT HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2015, (B)(6)'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6) MD, AT (B)(6) HEALTH CENTER IN (B)(6). AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, T.S. HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SU

  Patient problems: Foreign Body In Patient

  MAUDE report 20490266 ↗
• InjuryMay 20, 2024Adverse 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 THE ANGIODYNAMICS SMARTPORT. THE DEVICE WAS IMPLANTED BY DR. (B)(6), AT (B)(6), FOR THE PURPOSE OF CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF NECK SWELLING, ARM SWELLING, AND CONCERNS FOR SUPERIOR VENA CAVA SYNDROME, A SIGNIFICANT OBSTRUCTION OF BLOOD FLOW IN THE SUPERIOR VENA CAVA. CT IMAGING DEMONSTRATED SUPERIOR VENA CAVA SYNDROME SECONDARY TO INTERNAL JUGULAR CATHETER-ASSOCIATED LARGE THROMBUS WITH SIGNIFICANT VENOUS OBSTRUCTION WITH SECONDARY VENOUS COLLATERAL CIRCULATION AND ABNORMAL VENOUS SHUNT. ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT SURGERY PERFORMED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6), TO REMOVE THE SMARTPORT. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS SUSTAINED INJURIES AND DAMAGES AS DESCRIBED IN THIS COMPLAINT, AND HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 19351189 ↗
• MalfunctionApr 17, 2023Fracture; Fracture

  LANGDON & EMISON, LLC, A LAW GROUP, REPORTED AN INCIDENT REGARDING A SMARTPORT FROM A TANDEM CT VTX SLTIT 9.6F DET KIT. THE PATIENT PRESENTED FOR A SMARTPORT PLACEMENT ON (B)(6)2010, THE DEVICE WAS IMPLANTED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. IN (B)(6) 2012, IT WAS REPORTED THE SMARTPORT FRACTURED, PRESUMABLY THE CATHETER, CAUSING SEVERE INJURY TO THE PATIENT. ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY WITH DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6) TO REMOVE THE SMARTPORT AND THE FRACTURED CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16755023 ↗
• InjuryAug 24, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A CT VTX SLTIT 9.6F DET SMARTPORT. THE SMARTPORT WAS BEING PLACED USING A JUGULAR APPROACH. AFTER PLACEMENT, UNDER FOUROSCOPY, IT WAS NOTED THE CATHETER HAD BROKEN OFF FROM THE PORT. THE PATIENT WAS TAKEN BACK TO OR. AT A TERTIARY CARE LOCATION, UPON TRANSFER FOR RETRIEVAL, PARTIAL EMBOLIZATION OF A PIECE OF THE DEVICE PREVENTED FULL EXTRACTION AT THIS POINT THAT WILL REMAIN IN SITU WITH FOLLOW UP MONITORING BY THE VASCULAR SURGEON WHO RECEIVED THE PATIENT AND PERFORMED RETRIEVAL AND INSERTION OF NEW PORT. DEVICE SEQUESTERED PER RISK POLICY. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12362111 ↗
• InjuryJan 5, 2021Fracture; Fracture

  ON (B)(6) 2019, THE PATIENT PRESENTED FOR SUBCLAVIAN PLACEMENT OF A SMARTPORT FOR TREATMENT OF HER SARCOIDOSIS. APPROXIMATELY AROUND (B)(6) 2019, THE PATIENT PRESENTED FOR A REMICADE INFUSION AND REPORTED EXPERIENCING EXCRUCIATING PAIN DURING THE THERAPY. RADIOLOGY LATER DISCOVERED THAT THE CATHETER WAS FRACTURED, WITH A DISTAL FRAGMENT OVERLYING THE RIGHT LUNG BASE. THE PATIENT WAS THEN TRANSPORTED BY AMBULANCE TO (B)(6). FURTHER EVALUATION FOUND THAT CATHETER TIP WAS IN THE PATIENT'S PULMONARY ARTERY. THE DEFECTIVE DEVICE WAS REMOVED ON (B)(6) 2019 AND REPLACED WITH A BARD POWERPORT. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11116700 ↗
• InjuryJan 18, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, PORTACATH WAS PLACED ON (B)(6) 2018 FOR CHEMOTHERAPY DUE TO LUNG CANCER. FIRST CHEMO TREATMENT WAS ON (B)(6) 2018 AND THAT WENT FINE. ON (B)(6) 2018 THE PATIENT WAS ADMITTED WITH SEPSIS AND INFECTION "DUE TO PORTACATH." "THAT SAME DAY THEY REMOVED THE PORTACATH AND THEN UPON REMOVAL OF THE PORT A TINY PINPOINT PERFORATION WAS PRESENT ALONG THE PROXIMAL ASPECT OF THE CATHETER. THE LEAK WAS DISCOVERED UPON REMOVAL OF THE PORT AND THEN INJECTION UNDER PRESSURE WHILE KINKING THE END OF THE CATHETER. THE TIP WAS SENT FOR CULTURE WHICH WAS (B)(6) FOR (B)(6)." ADDITIONAL INFORMATION RECEIVED FROM THE RISK MANAGER INDICATES THAT THE PHYSICIAN (DR. (B)(6)) "CHECKS THE PORTS BEFORE THEY GET PLACED. HE FOUND NO HOLES ORPUNCTURE MARKS AT THE TIME OF PLACEMENT. HE BELIEVE THIS IS POSSIBLY A USER ERROR WHERE THE PORT WAS ENTERED." THE PORT FROM THE REPORTED EVENT WAS DISCARDED/NOT RETURNED TO ANGIODYNAMICS.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8262201 ↗
• InjuryJul 20, 2017Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  AS REPORTED, SMARTPORT PLACED FOR BLOOD DRAWS AND CHEMOTHERAPY ON (B)(6) 2017. PORT WAS BEING FLUSHED ON (B)(6) 2017 WHEN PATIENT EXPERIENCED PAIN AND THE PORT WAS DIFFICULT TO FLUSH. A FLOW STUDY THEN REVEALED THAT THE CATHETER HAD FRACTURED AND MIGRATED. THE DEVICE WAS SUCCESSFULLY REMOVED ON (B)(6) 2017 AND THE PATIENT CONDITION WAS LISTED AS "STABLE." THE USED PRODUCT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 6727628 ↗
• MalfunctionJun 27, 2017Difficult to Flush; Aspiration Issue; Difficult to Flush; Aspiration Issue

  AS REPORTED TO ANGIODYNAMICS ON JUNE 17, 2016 VIA MAUDE REPORT MW5063564: DR. (B)(6) HAS REMOVED A PORT THAT WAS PLACED BY DR. (B)(6) ON (B)(6) 2016. IT WAS REPORTED THE PORT WOULD NOT DRAW OR FLUSH, RESULTING IN THE NEED FOR REMOVAL. IT WAS REPORTED THE PATIENT HAD ONLY RECEIVED THREE TREATMENTS USING THIS DEVICE. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671014 ↗
• InjuryJun 14, 2017Fracture; Fracture

  AS REPORTED BY THE PATIENT: HAD A PORT SURGICALLY IMPLANTED ON (B)(6) 2016. THE PATIENT WAS SCHEDULED FOR A SERIES OF EIGHT CHEMOTHERAPY TREATMENTS. THE FIRST TREATMENT WAS (B)(6) 2017. FOUR WEEKS AFTER THE SECOND TREATMENT ((B)(6) 2017) THE PATIENT SAW HER PHYSICIAN AND HAD AN X-RAY WHICH SHOWED THAT THE CATHETER HAD BROKEN AND TRAVELED TO THE RIGHT VENTRICLE. ON (B)(6) 2017 THE PHYSICIAN RETRIEVED THE PIECES OF BROKEN CATHETER THROUGH A VEIN IN THE PATIENT'S NECK. THE PORT WAS (SCHEDULED TO BE) REMOVED ON (B)(6) 2017.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6639971 ↗
• InjuryMar 6, 2017Crack; Crack

  AS REPORTED TO ANGIODYNAMICS ON FEBRUARY 09, 2017: PORT PLACED ON (B)(6) 2016 FOR BLOOD DRAWS AND CHEMOTHERAPY. (B)(6) 2016, WHEN RECEIVING CHEMOTHERAPY, THE PATIENT EXPERIENCED PAIN, UNDER IMAGING, IT WAS NOTED THE CATHETER HAD DETACHED AND MIGRATED INSIDE OF THE PATIENT. IT WAS REPORTED THE CATHETER HAD NOT MIGRATED OUT OF THE RIGHT VENTRICLE. THE PORT AND FRACTURED CATHETER WERE REMOVED. A NEW OF THE SAME DEVICE WAS IMPLANTED IN A FUTURE PROCEDURE. IT WAS REPORTED THE PATIENT WAS STABLE POST EVENT. IT WAS REPORTED DEFECTIVE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; Pain

  MAUDE report 6381123 ↗
• InjuryMar 6, 2017Difficult to Flush; Occlusion Within Device; Difficult to Remove; Device Issue; Difficult to Flush; Occlusion Within Device; Difficult to Remove; Device Issue

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: PORT FAILURE DUE TO FIBRIN SHEATH. PORT HAD TO BE REMOVED BECAUSE IT WOULDN'T ASPIRATE OR INFUSE. IT WAS REPORTED DEFECTIVE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFATURER FOR A DEVICE EVALUATION.

  Patient problems: Infiltration into Tissue; No Known Impact Or Consequence To Patient

  MAUDE report 6381118 ↗

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