Smart Port CT CT75STSARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI H787CT75STSA0), received between Jun 27, 2017 and Mar 14, 2024 — classified as 6 injuries, 8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Fracture; Fracture

  A DISTRIBUTOR REPORTED THE FOLLOWING: "ON (B)(6) 2024, WE HAVE BEEN NOTIFIED BY MSA'S TERRITORY MANAGER OF AN INCIDENT INVOLVING THE REMOVAL/EXPLANT OF A SMART PORT (REF:(B)(4)) AND CATHETER FRACTURE. THE PORT IN QUESTION WAS IMPLANTED ON (B)(6) 2023 IN THE LEFT SUBCLAVIAN (FEMALE, 44Y.O., 70KG) AND (B)(6) DECEMBER 2023 (I.E. 48 DAYS IN SITU). IMPLANTATION AND EXPLANATION WERE PERFORMED BY THE SAME DOCTOR AT THE SAME HOSPITAL FACILITY. THE REASON FOR REMOVAL OF THE SMART PORT WAS REPORTEDLY DUE TO "IRRITATION" EXPERIENCED BY THE PATIENT. THE PATIENT HAD "ROUTINE ADMISSION ON (B)(6) 2023 FOR REMOVAL OF INFUSAPORT 0800. ON WITHDRAWAL OF THE CATHETER, SURGEON NOTED: "CATHETER WAS FRACTURED!" PATIENT RECOVERED AND REMAINED FASTING AND ADMITTED TO ANGIO FOR REMOVAL OF THE FRAGMENT (B)(6)2023 AT 1330HRS." DUE TO THIS THE PATIENT HAD AN UNPLANNED OVERNIGHT HOSPITAL ADMISSION (I.E. PROLONGED HOSPITALIZATION). IT HAS BEEN CONFIRMED WITH THE HOSPITAL, DUE TO THE DELAYED REPORTING OF THIS INCIDENT TO MSA, THE HOSPITAL HAS NOT RETAINED THE EXPLANTED SMART PORT FOR FURTHER INVESTIGATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18904296 ↗
• MalfunctionMay 15, 2023Fracture; Fracture

  THE PATIENT HAD A SMARTPORT, FROM A TANDEM ATO CT VTX SLTIT 7.5 ATT KIT, PLACED FOR CHEMOTHERAPY TREATMENT DUE TO PANCREATIC CANCER. THE PORT WAS PLACED LEFT SUBCLAVIAN. 4 MONTHS POST PLACEMENT, IT WAS REPORTED THAT THE PORT "STOPPED WORKING", SO THE PATIENT WENT IN FOR IMAGING. UNDER IMAGING, IT COULD BE SEEN THAT THE CATHETER LINE HAD FRACTURED AND HAD MIGRATED TO THE PATIENT'S PULMONARY TRUNK INTO THE PULMONARY ARTERIES. THE PATIENT THEN UNDERWENT EXPLANTATION ON (B)(6) 2023 AND HAD A NEW PORT WAS INSERTED. THE PORT BODY AND ATTACHED PORTION OF THE CATHETER WERE REMOVED AT THAT TIME. THIS MEANT THAT THERE WAS A DELAY IN CHEMOTHERAPY ACCESS, POTENTIALLY PROGRESSING THE DISEASE. A CHANGE IN MEDICATION (ANTICOAGULATION) WAS ALSO REQUIRED, ADDING FURTHER RISKS TO THE PATIENT. THE PATIENT STILL REQUIRES AN ADDITIONAL PROCEDURE IN A TERTIARY CENTRE TO REMOVE THE FRACTURED LINE THAT HAS MIGRATED. THE REPLACEMENT PROCEDURE HAD NOT BEEN PERFORMED AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient; Infiltration into Tissue

  MAUDE report 16932237 ↗
• MalfunctionJan 24, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT. PER THE INFORMATION PROVIDED: "TUBE BROKE OFF WITHIN MY BODY ABOVE MY HEART AND 140 MILLIMETRES OF TUBE FELL INTO HEART. I HAD ONLY BEEN UNDERTAKING NORMAL ACTIVITIES SUCH AS WORKING AT A DESK, WALKING, EXERCISE CLASSES ETC. PORT HAD STOPPED FUNCTIONING A FEW WEEKS BEFORE MY COMPLAINT WAS TAKEN SERIOUSLY BY MY ONCOLOGIST AND HE REFERRED ME FOR SCANS AT (INSTITUTION 1 [NAME REDACTED]) WHICH REVEALED THE BROKEN TUBE. THE BROKEN TUBE WAS REMOVED FROM MY HEART AT (INSTITUTION 2 [NAME REDACTED]) A FEW DAYS LATER, THE PROCEDURE WAS RECORDED. THE PORT WAS REMOVED AFTER I COMPLETED CHEMOTHERAPY A MONTH LATER."

  Patient problems: Foreign Body In Patient

  MAUDE report 16232965 ↗
• MalfunctionMay 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE SMARTPORT WAS PLACED IN THE RIGHT CHEST AND THE CATHETER WAS TUNNELED THROUGH THE RIGHT JUGULAR. THE PORT WAS ACCESSED EVERY THREE WEEKS FOR CHEMOTHERAPY TREATMENT. APPROXIMATELY 2 1/2 YEARS AFTER PLACEMENT, NURSING STAFF WERE ATTEMPTING TO ACCESS THE PORT, IN ORDER ADMINISTER CHEMOTHERAPY; HOWEVER, BLOOD WAS UNABLE TO BE ASPIRATED. THE PATIENT THEN COMPLAINED OF STINGING WHEN THE PORT WAS FLUSHED WITH 0.9% SODIUM CHLORIDE AND REPORTED FEELING A "POP". A CHEST X-RAY WAS PERFORMED AND THE CATHETER WAS NOTED TO HAVE COMPLETELY FRACTURED OFF THE PORT CHAMBER. THE CATHETER WAS SITTING IN SVC AND RIGHT ATRIUM, DOWN TO LEVEL OF THE TRICUSPID VALVE. ULTIMATELY, THE PATIENT REQUIRED SURGERY FOR REMOVAL AND SIMULTANEOUS REPLACEMENT OF THE PORT WITH ANOTHER OF THE SAME MODEL. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION (EXTRA DAY, X1) AND A DELAY IN RECEIVING INTRAVENOUS THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315065 ↗
• MalfunctionJun 23, 2020Fracture; Fracture

  AN END USER REPORTED AFTER PLACING THIS SMARTPORT CATHETER IN A PATIENT, IT SNAPPED WHEN THE SURGEON ATTEMPTED TO ADJUST THE POSITIONING. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10185717 ↗
• InjuryFeb 11, 2019Crack; Migration; Crack; Migration

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4) REGARDING AN IMPLANTED PORT: "THE PORT HAD BEEN IN-SITU FOR 6 MONTHS WHEN THE PATIENT HAD TO HAVE SOME OF THE CATHETER REMOVED FROM HIS HEART. THE PORT WAS STILL FIRMLY PLANTED IN ITS ORIGINAL POSITION WITH APPROXIMATELY 10-12 CM OF CATHETER ATTACHED". FURTHER DETAILS: THE PATIENT REPORTED BRUISING IN THE PORT AREA ON (B)(6) 2018. HE PRESENTED TO THE EMERGENCY DEPARTMENT WITH INCREASED BRUISING AND PAIN ON (B)(6) 2018. REMOVAL OF THE PORT AND IMPLANTATION OF ANOTHER PORT WAS COMPLETED ON (B)(6) 2018. THE MIGRATED CATHETER WAS LOCATED IN THE RIGHT ATRIUM. IMPLANTATION METHOD WAS SUBCLAVIAN. THERE WAS NO PATIENT INJURY. THE EXPLANTED PORT HAS BEEN KEPT FOR INVESTIGATION (THE DISTRIBUTOR IS ATTEMPTING TO OBTAIN THE PORT FOR RETURN TO ANGIODYNAMICS).

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 8326032 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4), ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), RECEIVED AN EMAIL FROM A CLINICAL NURSE CONSULTANT IN THE MEDICAL ONCOLOGY DEPARTMENT OF A MAJOR HOSPITAL IN (B)(6). THE EMAIL STATED: WE HAVE HAD AN INCIDENT RECENTLY WHERE A PATIENT RECEIVED AN AIR EMBOLUS FROM A PORT INSERTION. ONE OF THE RECOMMENDATIONS WILL BE TO USE VALVED INSERTION SHEATHS, TO PREVENT THIS OCCURRING AGAIN. IN A FOLLOW-UP PHONE CONVERSATION WITH AN (B)(4) REPRESENTATIVE THE CLINICAL NURSE CONSULTANT ALSO ADVISED: THE AIR EMBOLISM RESULTED IN DEATH. AN OFFICIAL INVESTIGATION IS UNDERWAY NOW AND THE HOSPITAL HAS DECIDED THAT USING A VALVED INSERTION SHEATH FOR PORT PLACEMENT IS REQUIRED. (B)(6) 2018: (B)(4) ATTEMPTED TO OBTAIN MORE INFORMATION FROM THE HOSPITAL RELATING TO THIS ADVERSE EVENT. THE HOSPITAL HAS SUPPLIED (B)(4) WITH NO FURTHER INFORMATION.

  Patient problems: Air Embolism; Death

  MAUDE report 8086145 ↗
• InjurySep 10, 2018Crack; Difficult to Remove; Crack; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), A SMART PORT HAD BEEN IMPLANTED IN A PEDIATRIC PATIENT (AGE UNKNOWN) ON (B)(6) 2015 FOR TREATMENT OF ACUTE LYMPHOBLASTIC LEUKEMIA. DIFFICULTY WAS ENCOUNTERED WHEN EXPLANTING THE PORT/CATHETER ON (B)(6) 2018: THE CATHETER WAS STUCK, AND WHEN PULLED ON, BROKEN. THE CATHETER WAS SUCCESSFULLY RETRIEVED. THE USED DEVICE WILL NOT BE RETURNED TO ANGIODYNAMICS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7860588 ↗
• MalfunctionJun 21, 2018Aspiration Issue; Aspiration Issue

  AS REPORTED BY DISTRIBUTOR IN (B)(6), HOSPITAL HAS A SURGEON WHO IS HAVING ISSUES WITH THE SMART PORT. AFTER BEING IMPLANTED THE RIGHT SIDE PLACEMENT CATHETERS TEND TO CURVE. THE CURVE CREATED SOMETIMES CAUSES THE TIP TO REST AGAINST THE WALL OF THE IVC, AFFECTING ASPIRATION. IN THIS ONE CASE, THE PHYSICIAN OPTED TO HAVE THE PORT/CATHETER REMOVED AND REPLACED. THE PATIENT'S CONDITION IS REPORTED AS "STABLE." THE USED DEVICE HAS BEEN DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624535 ↗
• MalfunctionApr 26, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DIFFICULTY WAS ENCOUNTERED ON (B)(6) 2017 BY A PHYSICIAN ATTEMPTING TO REMOVE A SMART PORT WHICH HAD BEEN INSERTED ON (B)(6) 2015 : "TUBING VERY ROUGHENED; TOOK UNUSUAL FORCE TO REMOVE, VERY NEARLY NEEDED EXTRA INCISION." NO INJURY TO PATIENT WAS REPORTED. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7465277 ↗
• InjuryApr 5, 2018Crack; Migration or Expulsion of Device; Crack; Migration or Expulsion of Device

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6): INCIDENT AT A CHILDREN'S HOSPITAL - "THE SURGEON ADVISED THAT THE CATHETER SNAPPED AT THE LEVEL OF THE CLAVICLE - THE CATHETER PIECE WAS FOUND IN THE PULMONARY ARTERY. THE PATIENT REQUIRED EMERGENCY THEATRE, ANGIOGRAM AND REMOVAL OF THE SMART PORT." ANGIODYNAMICS IS ATTEMPTING TO OBTAIN THE USED DEVICE FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7398687 ↗
• InjuryOct 26, 2017Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), (B)(6) REPORTED THAT WHEN ACCESSING A SMARTPORT IMPLANTED IN THE CHEST, SWELLING TO THE SITE WAS NOTED UPON FLUSHING. IT WAS CONFIRMED BY X-RAY THAT THE CATHETER HAD DISCONNECTED / FRACTURED FROM THE HUB. THE PORT WAS EXPLANTED ON (B)(6) 2017. IT HAD BEEN IN PLACE FOR 3 YEARS, AS IT WAS IMPLANTED ON (B)(6) 2014. THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Swelling

  MAUDE report 6979233 ↗
• InjuryJul 11, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: ON (B)(6) 2016, THEATRE NURSE OF A CHILDREN'S HOSPITAL ADVISED OF INCIDENT WITH SMART PORT CAT# CT75STSA LOT# 5039018. THE THEATRE NURSE ADVISED THAT THEY WERE UNABLE TO ACCESS OR FLUSH SMART PORT IMPLANTED IN A (B)(6) FEMALE CHILD. A CHEST X-RAY CONFIRMED CATHETER WAS FRACTURED. SURGERY WAS PERFORMED ON (B)(6) 2016 TO REMOVE FRACTURED CATHETER FROM PULMONARY ARTERY. THE PATIENT'S PORT AND ATTACHED CATHETER WERE ALSO REMOVED. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6701848 ↗
• MalfunctionJun 27, 2017Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A SMARTPORT WAS IMPLANTED IN A PATIENT ON (B)(6) 2017 AND IT "WASN'T WORKING CORRECTLY," SO IT WAS REMOVED ON (B)(6) "1017". THE END USER HOSPITAL IS BEING CONTACTED FOR ADDITIONAL DETAILS. THE USED PORT HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6670874 ↗

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