Smart Port CT CT75STSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI H787CT75STSD0), received between Feb 13, 2017 and Dec 13, 2024 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 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 AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER CT75STSD AND LOT NUMBER: 4837818. THE DEVICE WAS IMPLANTED BY DR. RAFI SIDDIQI, MD, AT INDIANA UNIVERSITY HEALTH BEDFORD HOSPITAL IN BEDFORD, INDIANA, FOR ONGOING CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2017, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF AN INFECTION. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT PLAINTIFF HAD DEVELOPED AN INFECTION AND IDENTIFIED THE SMARTPORT AS THE SOURCE. DR. (B)(6), MD, SUBSEQUENTLY REMOVED THE DEFECTIVE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 20925694 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Infusion or Flow Problem; Separation Problem; Detachment of Device or Device Component; Infusion or Flow Problem; Separation Problem

  AN END USER REPORTED AN ISSUE WITH A SINGLE TITANIUM CT VTX PORT W SILC CATH. THE PATIENT WAS EXPERIENCING LEFT HAND NUMBNESS AND DIFFICULTY INFUSING THROUGH THE PORT; HOWEVER, THE DECISION WAS MADE TO EXPLANT THE DEVICE. DURING REMOVAL OF THE PORT, ONLY ABOUT 5 CM OF THE CATHETER WAS ABLE TO BE REMOVED. A C-ARM VIEW SHOWED THE LINE REMAINED, JUST INFERIOR TO THE CLAVICLE. THE PATIENT WAS TRANSFERRED TO IR AND HAD THE REMAINING CATHETER REMOVED ON THE SAME DAY. IT IS UNKNOWN IF THE DEVICE FRACTURED PRIOR TO OR DURING THE REMOVAL PROCEDURE.

  Patient problems: Foreign Body In Patient; Numbness

  MAUDE report 19793709 ↗
• MalfunctionJul 1, 2024Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  A NURSE AND DISTRIBUTOR REPORTED SEVERAL ISSUES WITH A SINGLE TITANIUM CT VTX PORT W SILC CATH. THE FOLLOWING DATES AND EVENTS WERE PROVIDED: (B)(6) 2023 - A PORTOGRAM OF THE PATIENT'S CHEST WAS PERFORMED AS PORT WAS FLUSHING BUT NOT ASPIRATING. TEST CONFIRMED PORT WAS IN CORRECT POSITION AND NOT LEAKING. (B)(6) 2024 - PORT WAS NOT ASPIRATING WHEN ATTEMPTED TO BE USED FOR ROUTINE INFUSION (B)(6) 2024 - A PORTOGRAM WAS PERFORMED AND PORT WAS FOUND TO BE DISCONNECTED AND TUBING HAD MIGRATED INTO THE PATIENT'S LEFT MAIN PULMONARY ARTERY (B)(6) 2024 - PATIENT UNDERWENT A PROCEDURE WITH INTERVENTIONAL RADIOLOGY. TUBING WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S PULMONARY ARTERY (B)(6) 2024- PORT HUB REMOVED WITH SMALL PORTION OF TUBING ATTACHED TO HUB. NEW VORTEX TR LOW PROFILE TITANIUM PORT WITH PRE-ATTACHED SILICONE 6.6FR CATHETER WAS INSERTED. PRESENTLY, THE PATIENT HAS BEEN DISCHARGED HOME AND IS RESUMING NORMAL ACTIVITIES. AS EXPECTED FOLLOWING PORT REMOVAL, THERE WAS SOME BRUISING AND LOCAL PAIN AT THE CHEST SITE WHICH HAS SINCE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651501 ↗
• MalfunctionMar 12, 2024Complete Blockage; Detachment of Device or Device Component; Complete Blockage; Detachment of Device or Device Component

  A DISTRIBUTOR, MEDICAL SPECIALTIES AUSTRALASIA (MSA), REPORTED BEING NOTIFIED OF THE FOLLOWING ISSUE WITH A SINGLE TITANIUM CT VTX PORT W SILC CATH: "MSA HAS BEEN NOTIFIED BY OUR AUSTRALIAN REGULATORY AUTHORITY (TGA THERAPEUTIC GOODS ADMINISTRATION), VIA EMAIL, OF AN INCIDENT INVOLVING A SMARTPORT CT. THE NAME OF THE HEALTHCARE PROFESSIONAL AND THE HOSPITAL INVOLVED WERE BOTH REDACTED BY THE TGA, BEFORE NOTIFYING MSA. PATIENT WAS DUE FOR MONTHLY TREATMENT THAT REQUIRED PORT ACCESS TO ADMINISTER MEDICATION. PORT/CATHETER WAS NOT ABLE TO BE ASPIRATED OR FLUSHED AND WAS COMPLETELY BLOCKED. PORT-O-GRAM PERFORMED AND SHOWED CATHETER HAD DISLODGED AND MIGRATED INTO THE PULMONARY ARTERY REQUIRING FLUOROSCOPIC GUIDED RETRIEVAL." DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: Failure of Implant

  MAUDE report 18891606 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT IS EXPERIENCING A "TRUE ALLERGY' TO A SINGLE TITANIUM CT VTX PORT, W SILC CATHETER. THE PHYSICIAN WAS INQUIRING WHAT TYPE OF MATERIALS THE PORT IS COMPRISED OF AND NOTED THAT THE PATIENT HAS BEEN SENT FOR FURTHER ALLERGY TESTING. THESE RESULTS ARE STILL SPENDING. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL STEROIDS FOR ONE MONTH BUT ULTIMATELY HAD THE PORT REMOVED. ONCE THE PORT WAS REMOVED, THE RASH RESOLVED WITHIN 24 HOURS AND THE PATIENT IS DOING WELL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18256649 ↗
• MalfunctionMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PITTMAN, DUTTON, HELLUMS, BRADLEY & MANN P.C., A LAW GROUP, REPORTED AN INCIDENT REGARDING A SMARTPORT FROM A SINGLE TITANIUM CT VTX PORT W SILC CATH KIT. THE DEVICE WAS IMPLANTED BY DR.(B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY ON (B)(6) 2020. IN OR ABOUT (B)(6) 2021, THE SMARTPORT MALFUNCTIONED, CAUSING SEVERE INJURY TO PLAINTIFF. THE PATIENT REPORTEDLY EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAD SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, AND HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE INJURIES, CONDITIONS, AND COMPLICATIONS SUFFERED BY THE PATIENT WERE REPORTED TO BE HEMORRHAGE; CARDIAC/PERICARDIAL TAMPONADE; CARDIAC ARRHYTHMIA AND OTHER SYMPTOMS SIMILAR TO MYOCARDIAL INFARCTION; SEVERE AND PERSISTENT PAIN; PERFORATIONS OF TISSUE, VESSELS AND ORGANS. ON OR ABOUT (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6) TO REMOVE THE SMARTPORT AND THE MALFUNCTIONED CATHETER.

  Patient problems: Cardiac Tamponade; Internal Organ Perforation; Pain; Perforation of Vessels

  MAUDE report 16938861 ↗
• MalfunctionMar 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AN END USER NOTED A PRODUCT ISSUE WITH THE PORT FROM A TANDEM SINGLE TITANIUM CT VTX PORT W SILC CATH KIT. WHEN REMOVING A SMARTPORT FROM A PATIENT THAT HAD BEEN PLACED APPROXIMATELY 7 MONTHS PRIOR, IT WAS NOTED THE SEPTUM/ACCESS MEMBRANE OF THE PORT HAD SIGNIFICANT DAMAGE IT. DUE TO SWELLING AT THE PLACEMENT SITE DURING AN INFUSION TREATMENT SESSION, IT WAS DETERMINED TO IMMEDIATELY REMOVE AND REPLACE THE PORT. THE PORT WAS USED ONCE EVERY TWO WEEKS FOR LIFELONG TREATMENT THERAPY. IT WAS CONFIRMED BY THE ACCOUNT THAT APHERESIS WAS USED ON THIS PATIENT. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: Swelling/ Edema

  MAUDE report 16645607 ↗
• MalfunctionFeb 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PORT FROM A TANDEM SINGLE TITANIUM CT VTX PORT W SILC CATH KIT. MSA HAD BEEN NOTIFIED AN ISSUE WITH A PATIENT'S SMART PORT CT. DURING A PORT CHECK, THERE WAS NOTED FORMATION OF A FIBRIN SHEATH ON THE CATHETER. ALTEPLASE WAS ADMINISTERED, HOWEVER, THE ISSUE STILL PERSISTED. THE PORT WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16418626 ↗
• InjuryDec 29, 2022Fracture; Fracture

  A DIRECTOR OF CLINICAL SERVICES REPORTED AN ISSUE WITH A SINGLE TITANIUM CT VTX PORT. DURING A PLACEMENT PROCEDURE, THE CATHETER HAD A MATERIAL BREAK FROM THE PORT (IT DID NOT DETACH FROM THE PORT) WITHIN THE PATIENT'S BRACHIOCEPHALIC VEIN; THE CATHETER RETRACTED INTO THE VEIN AND MIGRATED IN THE SUPERIOR VENA CAVA. THE PATIENT WAS IMMEDIATELY TRANSFERRED FROM THE OPERATING ROOM, VIA EMERGENCY VEHICLE, TO COVENANT MEDICAL CENTER WHERE THEY WERE TAKEN TO INTERVENTIONAL RADIOLOGY. THE CATHETER REMNANT WAS REMOVED FROM THE PATIENT AND A NEW PORT WAS PLACED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16068906 ↗
• InjuryDec 27, 2022Fracture; Fracture

  A NURSE/ QUALITY AND EDUCATION DIRECTOR REPORTED AN ISSUE WITH A SINGLE TITANIUM CT VTX PORT PLACED ON (B)(6) 2022. THE PORT WAS PLACED IN THE PATIENT'S LEFT SUBCLAVIAN VEIN.  A PATIENT PRESENTED TO A CANCER CENTER ((B)(6) 2022) FOR AN INFUSION; HOWEVER, THE NURSE WAS UNABLE TO DRAW BLOOD FROM PORT; THEREFORE, A CHEST X-RAY WAS OBTAINED, PER THE CENTER PROTOCOL.  THE X-RAY NOTED THAT A PORTION OF THE TUBING OF THE IMPLANTED PORT HAD BROKEN OFF AND WAS LODGED IN THE PATIENT'S HEART.  (B)(6) 2022 THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE SHE WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER FACILITY IN ORDER TO HAVE THE PORTION OF TUBING REMOVED.  UNKNOWN IF SAME OR DIFFERENT DEVICE WAS PLACED AFTER REMOVAL. THE PATIENT REPORTED THE DAY PRIOR TO THIS EVENT, THAT SHE WAS EXPERIENCING CHEST DISCOMFORT, WHICH SHE BELIEVED TO BE RELATED TO ANXIETY, SO SHE TREATED WITH XANAX. AFTER TAKING THE MEDICATION, THE PAIN RESOLVED.  AS OF (B)(6) 2022, THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING WELL. ADDITIONAL INFORMATION PROVIDED REPORTED IT WAS UNKNOWN HOW OFTEN THE PORT WAS ACCESSED. ALSO PROVIDED WERE THE PATIENT MEDICATIONS. PRIOR TO PRESENTING TO THE CANCER CENTER ON THE DA

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Pain

  MAUDE report 16052372 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  A QA COORDINATOR REPORTED AND ISSUE WITH A SINGLE TITANIUM CT VTX PORT, WITH SILC CATH. UPON PLANNED REMOVAL OF THE DEVICE, THE PORT-A-CATH WAS GRASPED AND GRADUALLY REMOVED FROM THE AREA; HOWEVER, IT WAS NOTED THAT THE TUBING WAS FRACTURED DISTALLY, TO WHERE IT ENTERED THE PATIENT'S VEIN. THE DECISION WAS MADE TO LEAVE THE FRAGMENT IN SITU. THE PORT HAD BEEN ACCESSED (B)(6) 2022 AND THE FOLLOWING MEDICATIONS WERE ADMINISTERED: TAXOTERE/ CYCLOPHOSPHAMIDE, ALOXI, DECADRON, PEPCID AND BENADRYL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE; HOWEVER, THE PATIENT WILL NEED SCHEDULED CARDIAC ECHOS TO MONITOR THE PLACEMENT OF THE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15412260 ↗
• InjuryMar 17, 2022Fracture; Fracture

  A CUSTOMER CALLED AND REPORTED A PATIENT HAD EXPERIENCED AN ISSUE WITH A PORT. THE PORT HAD BEEN PLACED IN (B)(6) 2021, AND A CHEST X-RAY IN (B)(6) 2021 SHOWED THE PORT WAS FINE WITH NO NOTED ISSUES. THE CATHETER WAS TUNNELED THROUGH THE CLAVICLE. PATIENT PRESENTED TO CANCER CENTER FOR A CHEMOTHERAPY INFUSION. WHEN PORT WAS FLUSHED WITH MINIMAL PRESSURE, THE PATIENT BECAME SHORT OF BREATH AND COMPLAINED OF CHEST PAIN. SHE WAS TAKEN TO THE ER WHERE A CHEST X-RAY WAS TAKEN AND SHOWED A PORTION OF THE TUBING FROM THE PORT HAD BROKEN OFF AND WAS LODGED IN THE PATIENT'S HEART. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM WHERE SHE WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE THE PORTION OF TUBING REMOVED. IT WAS REPORTED THAT THREE ATTEMPTS WERE MADE TO REMOVE THE CATHETER, AND ON THE THIRD ATTEMPT, THEY WERE ABLE TO REMOVE THE FRAGMENT VIA GROIN ACCESS. AT THE TIME OF REPORTING THIS ISSUE, THE PORT BODY WAS STILL IMPLANTED. IT IS UNKNOWN IF THE CATHETER FRAGMENT WAS RETAINED OR DISPOSED OF. IT WAS REPORTED THE PATIENT WAS RELEASED THE DAY AFTER THE FRAGMENT WAS REMOVED AND IS DOING WELL

  Patient problems: Chest Pain; Decreased Respiratory Rate; Foreign Body In Patient

  MAUDE report 13802452 ↗
• InjuryJun 23, 2020Fracture; Fracture

  THE END USER REPORTED THAT AN INDWELLING SINGLE TITANIUM CT VTX PORT CATHETER HAD FRACTURED AND MIGRATED TO A PATIENT'S HEART. THE CATHETER WAS RETRIEVED AND THE PORT WAS REMOVED. THE PORT WAS REPLACED WITH A PICC. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10184365 ↗
• InjuryMar 9, 2020Fracture; Fracture

  AS REPORTED: ON THE (B)(6) 2020 THE SURGEON PROVIDED THE FOLLOWING COMPLAINT DESCRIPTION: "FRACTURED CATHETER, REQUIRED TO BE RETRIEVED ENDOVASCULAR PROCEDURE USING A SNARE. CATHETER REMOVED (B)(6) 2020, REMAINING CATHETER IN RIGHT VENTRICLE REMOVED (B)(6) 2020 ENDOVASCULAR PROCEDURE" THE SURGEON PROVIDED AN X-RAY AND PORT-A-GRAM IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2020. CATHETER REMOVED (B)(6) 2020. REMAINDER OF CATHETER REMOVED (B)(6) 2020 (ENDOVASCULAR PROCEDURE TO RETRIEVE CATHETER (B)(6) 2020). THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9805813 ↗
• InjuryOct 28, 2019Fracture; Fracture

  ANGIODYNAMICS RECEIVED A USER MEDWATCH OCTOBER 08 2019, REFERENCE (B)(4). AS REPORTED, A PATIENT WAS SCHEDULED TO HAVE MEDIPORT INJECTION BECAUSE PORT WAS NOT DRAWING BLOOD. ONCE THE PORTOGRAM WAS DONE, IT WAS FOUND THAT THE MEDIPORT WAS FRACTURED WITH THE CATHETER TIP IN THE RIGHT ATRIUM/RIGHT VENTRICLE. THE PATIENT THEN HAD TO HAVE A PROCEDURE IN THE RADIOLOGY DEPARTMENT TO REMOVE THE CATHETER TIP. THE CATHETER TIP WAS SAVED FOR FAILURE ANALYSIS. THE MEDIPORT WILL BE REMOVED AT AN UNKNOWN FUTURE DATE. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9244376 ↗
• MalfunctionOct 3, 2019Entrapment of Device; Fracture; No Flow

  A PATIENT WAS SCHEDULED TO HAVE MEDIPORT INJECTION BECAUSE PORT WAS NOT DRAWING BLOOD. ONCE THE PORTAGRAM WAS DONE, IT WAS FOUND THAT THE MEDIPORT WAS FRACTURED WITH THE CATHETER TIP IN THE RIGHT ATRIUM/RIGHT VENTRICLE. THE PATIENT THEN HAD TO HAVE A PROCEDURE IN THE RADIOLOGY DEPARTMENT TO REMOVE THE CATHETER TIP. THE CATHETER TIP WAS SAVED FOR FAILURE ANALYSIS. THE MEDIPORT WILL BE REMOVED AT AN UNKNOWN FUTURE DATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9151665 ↗
• InjuryMar 28, 2019Crack; Crack

  AS REPORTED ON VOLUNTARY MEDWATCH, MW5084130, "PATIENT CAME IN FOR AN INFUSAPORT REMOVAL AFTER USE OF 5 YEARS. SNAP HEARD/FELT WHEN REMOVING CATHETER. THE DISTAL HALF OF THE CATHETER REMAINED AND REQUIRED EXTENDED PROCEDURE TO REMOVE SUCCESSFULLY." NO FOLLOW-UP INTO THIS EVENT WAS POSSIBLE DUE TO LACK OF INFORMATION PROVIDED - NO HOSPITAL NAME WAS GIVEN AND A SEARCH INTO ANGIODYNAMICS' SHIPPING HISTORY FOR THE PROVIDED PORT/LOT # SHOWED THAT IT HAD SHIPPED TO 20 DIFFERENT HOSPITALS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8459899 ↗
• MalfunctionNov 19, 2018Infusion or Flow Problem; Infusion or Flow Problem

  ANGIODYNAMICS RECEIVED A CALL ON THE VASCULAR ACCESS CLINICAL HOTLINE FROM DR. (B)(6), (B)(6) OF ICU AT (B)(6) HOSPITAL ON (B)(6) 2018. HE STATED HE IS CARING FOR A PATIENT THAT HAS A 7.5 FR. SMART PORT WHICH WAS PLACED IN 2017. EARLIER IN THE DAY, A NURSE IN THE REHAB UNIT CRUSHED A PILL OF ORAL CARDIZEM, MIXED IT WITH TAP WATER (VOLUME OF TAP WATER IT WAS MIXED WITH UNKNOWN), AND ADMINISTERED IT THROUGH THE PORT. HE WAS NOT SURE IF A POST-MEDICATION FLUSH WAS PERFORMED. HE STATED UPON FURTHER INVESTIGATION OF THE PORT SITE, ORANGE PRECIPITATE WAS VISUALIZED IN THE PORT EXTENSION TUBING AND THE PORT WAS COMPLETELY OCCLUDED. HE ALSO STATED THAT THE MEDICATION DID GO THROUGH THE PORT AND FEARED THERE IS ALSO DRUG PRECIPITATE IN THE PORT RESERVOIR AND CATHETER. PATIENT IS STABLE AND UPSET THAT THEY CANNOT DRAW BLOOD FROM HER PORT FOR LABS. DR. (B)(6) FEELS THE BEST COURSE OF ACTION IS TO REMOVE THE PORT RATHER THAN CONTACTING THE PHARMACY FOR POSSIBLE ALTERNATIVE SOLUTIONS. INSTRUCTED DR. (B)(6) THAT IF PORT IS REMOVED TO RETURN TO ANGIODYNAMICS FOR INVESTIGATION. STATES HE WILL PASS THAT MESSAGE ALONG TO THE SURGEON. FURTHER INFORMATION RECEIVED FROM DR. (B)(6) INDICATED THAT THE PO

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8085768 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY ANGIODYNAMICS DISTRIBUTOR IN (B)(4), "A PATIENT DEVELOPED AN AIR EMBOLISM AT THE TIME OF THE INNER DILATOR WAS REMOVED BEFORE THE PORT TUBING WAS INSERTED". IT WAS INDICATED THAT TYPICALLY "A PROCEDURALIST WILL ATTEMPT TO PREVENT THIS COMPLICATION BY REMOVING THE INNER DILATOR DURING EXPIRATION, TO AVOID AIR BEING SUCKED INTO THE SHEATH CATHETER THAT REMAINS OPEN TO AIR". NO DEVICE WILL BE RETURNED FOR EVALUATION. THE PORT FROM THE PRODUCT KIT WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Air Embolism

  MAUDE report 7780597 ↗
• MalfunctionNov 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED CHEST PORT WHICH HAD BEEN IMPLANTED IN (B)(6) 2014 WAS REMOVED ON (B)(6) 2017 IN SURGERY UNDER GENERAL ANESTHESIA. AFTER REMOVAL, THE PORT WAS ACCESSED AND WAS NOTED TO BE LEAKING FROM THE TUBING AND PORT STEM CONNECTION. NO PATIENT INJURY WAS INDICATED. IT HAS BEEN STATED THAT THE USED PORT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7045502 ↗
• InjuryFeb 15, 2017Crack; Device Issue; Crack; Device Issue

  AS REPORTED ON JANUARY 23, 2017 TO ANGIODYNAMICS BY THE PATIENT'S WIFE: DURING A ROUTINE PORT FLUSH ON (B)(6) 2016 MY HUSBAND FELT AN UNUSUAL BURNING AND PAIN WHEN THE FLUSH WAS INSERTED; THIS CONCERNED HIS ONCOLOGY TEAM. DUE TO THE LATE AFTERNOON APPOINTMENT WITH THE ONCOLOGY TEAM, THE PORT POSITION STUDY WAS SCHEDULED AND PERFORMED THE NEXT MORNING. THE INTERVENTION RADIOLOGIST IMMEDIATELY FOUND THAT A LARGE SECTION OF THE TUBING HAD BROKEN OFF. THE STRAY PIECE WAS VISIBLE ON X-RAY AND WAS ABLE TO BE RETRIEVED AFTER A LENGTHY PROCEDURE. THE PORT AND WHAT TUBING REMAINED ATTACHED TO IT WERE ALSO REMOVED AT THIS TIME. THE PORT WAS NOT REPLACED, AS THIS WAS THE PATIENT'S FINAL CHEMOTHERAPY TREATMENT. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED DEFECTIVE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Burning Sensation; Device Embedded In Tissue or Plaque; Pain

  MAUDE report 6332358 ↗
• MalfunctionFeb 13, 2017Difficult to Flush; Device Issue; Difficult to Flush; Device Issue

  AS REPORTED ON JANUARY 27, 2017: THE ORIGINAL PORT INSERTED ON (B)(6) 2017. THE PATIENT CAME BACK TO FACILITY FOR PORT CHECK ON (B)(6) 2017 DUE TO IT NOT ALLOWING IT TO ASPIRATE OR FLUSH. THE SURGEON TRIED AS WELL AND COULD NOT GET IT TO WORK. THE PORT WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6325281 ↗
• InjuryFeb 13, 2017Device Issue; Device Issue

  AS REPORTED ON (B)(6) 2017: THE IMPLANT WAS PLACED ON (B)(6) 2016. WHEN PATIENT RETURNED FOR A CHEMO INFUSION ON (B)(6) 2016, THEY WERE UNABLE TO CORRECTLY ACCESS MEDIPORT AND PATIENT COMPLAINED OF DISCOMFORT WHEN INJECTING SALINE. NOTES STATE THAT THE AREA WAS SWOLLEN. TREATMENT WAS GIVEN PERIPHERALLY FOR THAT DAY. THE FOLLOWING DAY THE MEDIPORT WAS REMOVED. A NEW MEDIPORT OF THE SAME MODEL WAS PLACED ON (B)(6) 2017. RECORDS SHOW SUCCESSFUL CHEMO INFUSIONS AFTER THAT DATE. PATIENT WAS BEING TREATED FOR OVARIAN CANCER. THERE IS NO PRIOR PORT PLACEMENT AT THIS HEALTHCARE FACILITY, NO IMAGES ARE AVAILABLE, NO PERMANENT DAMAGE WAS DONE, AND HOSPITALIZATION WAS NOT NECESSARY, WITH THE EXCEPTION OF THE PRE-OP AND POST-OP TIME REQUIRED OF PLACING A NEW PORT. IT WAS REPORTED DEFECTIVE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Burning Sensation; Pain

  MAUDE report 6325258 ↗

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