Smart Port CT CT96STSARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H787CT96STSA0), received between May 1, 2019 and Oct 28, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2014, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 4728535. THE DEVICE WAS IMPLANTED BY DR. (B))6), MD, AT (B)(6) HOSPITAL, FOR THE PURPOSE OF PROVIDING VASCULAR ACCESS. ON OR ABOUT (B)(6) 2015, PLAINTIFF WAS DIAGNOSED WITH THROMBUS APPEARING ROUND STRUCTURES AT THE BASE OF THE RIGHT ATRIUM AND SUPERIOR VENA CAVA AT (B)(6). PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE THROMBOSIS AND THAT THE DEFECTIVE PORT HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2015 PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20547795 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  ON OR ABOUT (B)(6) 2013 PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 582307. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AT (B)(6), FOR THE PURPOSE OF PROVIDING VASCULAR ACCESS. ON OR ABOUT (B)(6) 2013, PLAINTIFFS PORT WAS FOUND TO HAVE A FRACTURED CATHETER AT THE CLAVICULAR THAT REQUIRED PORT REMOVAL AND REPLACEMENT. ON OR ABOUT (B)(6) 2013 PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6) HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547654 ↗
• MalfunctionOct 24, 2020Fracture; Fracture

  A DISTRIBUTOR REPORTED RECEIVING INFORMATION, FROM A HEALTH PROFESSIONAL, REGARDING AN ISSUE WITH A SMARTPORT CT. DURING A PROCEDURE, THE VEIN DILATOR'S OUTER SHEATH SPLIT/FRACTURED AND CRUMPLED, AT THE DISTAL END TOWARDS PROXIMAL END, WHILE ATTEMPTING TO DILATE THE PATIENT'S VEIN. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO REPORT OF PERMANENT PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731851 ↗
• InjuryJul 25, 2019Difficult to Flush; Difficult to Flush

  AS REPORTED BY ANGIODYNAMICS BY (B)(4) DISTRIBUTOR: ON (B)(6) 2019, CLINICAL TEAM LEADER OF HOSPITAL ADVISED: "YESTERDAY FOR THE INSERTION OF PORTACATH PROCEDURE USING THE SMART PORT CT, WE HAD A FAULTY PORT. PRIOR TO INSERTION TO THE PATIENT, THE PORT WAS PREPARED AND FLUSHED CORRECTLY WITH HEPARINISED SALINE. THE PORT WAS THEN INSERTED INTO THE PATIENT. SURGEON THEN WENT TO FLUSH THE PORT WITH HEPARINISED SALINE. HE ATTEMPTED TO ASPIRATE BLOOD PRIOR TO FLUSHING, HOWEVER COULD ONLY ASPIRATE AIR WITH NO BLOOD. THE CONNECTION TO THE NEEDLE AND PORT WAS DOUBLE CHECKED HOWEVER THE SAME THING WAS HAPPENING. SURGEON WAS CONCERNED ABOUT A POTENTIAL FAULTY CONNECTION OR HOLE IN THE TUBING CAUSING AIR. THE PORT HAD TO BE IMMEDIATELY REMOVED AT THE RISK OF AIR BEING INTRODUCED INTO THE PATIENT AND A NEW PORT OPENED AND INSERTED." ON 1 JULY 2019, CLINICAL TEAM LEADER PROVIDED FURTHER INFORMATION ON THE INCIDENT: IMPLANTATION: OPEN METHOD; RIGHT IJV PUNCTURED AND PORT PLACED ON RIGHT CHEST WALL; FORCEPS USED DURING IMPLANTATION: DEBAKEY FORCEPS; IMAGING DURING PROCEDURE: THE PROCEDURE WAS PERFORMED UNDER IMAGING; FREQUENT SCREENINGS WERE DONE AT THE STAGE OF NEEDLE PUNCTURING, WIRE INSERTING,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826486 ↗
• InjuryMay 1, 2019Fracture; Material Fragmentation; Fracture; Material Fragmentation

  COMPLAINT CALLED IN BY PATIENT: " "HAD A PORT PUT IN AND THEN HAD IT TAKEN OUT, OR TRIED, WHEN THEY WERE TAKING IT OUT IT BROKE. THEY COULDN'T GET IT OUT AND HAD TO GO TO ANOTHER SURGEON, THEN THRU (THE) GROIN TO TRY AND GET IT OUT AND IT'S STILL THERE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8568359 ↗

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