Smart Port CT CT80STPDRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI H787CT80STPD0), received between Jan 6, 2017 and Feb 21, 2025 — classified as 2 deaths, 40 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fracture” (31 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 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6), CALLED INTO ANGIODYNAMICS' CUSTOMER SERVICE INQUIRING ABOUT WHETHER OR NOT SHE IS SAFE TO UNDERGO AN MRI WHILE HAVING A RETAINED FRAGMENT FROM A SINGLE TITANIUM CT VTX PORT W POLY CATH, THAT WAS PREVIOUSLY IMPLANTED. (B)(6), REPORTED THAT DURING A PORT REMOVAL PROCEDURE, 5 YEARS AGO, A PIECE BROKE OFF THE DEVICE AND REMAINS INSIDE OF HER CHEST. DESPITE MULTIPLE GOOD FAITH EFFORT ATTEMPTS, NO FURTHER DETAILS WERE OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21433149 ↗
• MalfunctionFeb 19, 2025Fracture; Fracture

  ON OR ABOUT (B)(6) 2015, PLAINTIFF UNDERWENT PORT PLACEMENT, DURING WHICH AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER: CT80STPD AND LOT NUMBER: 4921248, WAS IMPLANTED BY DR. (B)(6)., AT (B)(6) FOR ONGOING CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2017, PLAINTIFF PRESENTED TO (B)(6) WITH COMPLAINTS OF DISCOMFORT. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT PLAINTIFF'S SMARTPORT HAD FRACTURED. DR. (B)(6)., SUBSEQUENTLY REMOVED THE DEFECTIVE DEVICE. 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: Discomfort

  MAUDE report 21412634 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2010, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT PRODUCT, MODEL #: 215990. CATALOG NBR: CT80STPD, AND LOT #: 513799, FOR THE PURPOSES OF PLAINTIFF'S CHEMOTHERAPY. UPON INFORMATION AND BELIEF, THE AFOREMENTIONED DEVICE'S DESCRIPTION IS AS FOLLOWS: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66 CM POLYURETHANE CATHETER AND 8F INTRODUCER KIT. UPON INFORMATION AND BELIEF, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD., (B)(6), FOR THE PURPOSES INDICATED ABOVE. ON OR ABOUT (B)(6) 2017, UPON INFORMATION AND BELIEF, PLAINTIFF PRESENTED TO THE (B)(6), WITH FLU-LIKE SYMPTOMS, WHICH PLAINTIFF DEVELOPED WHILE TRAVELLING FROM (B)(6). WHILE IN (B)(6), UPON INFORMATION AND BELIEF, PLAINTIFF CAME UNDER MEDICAL CARE OF DR. (B)(6), M.D. UPON INFORMATION AND BELIEF, PLAINTIFF HAD ECHOCARDIOGRAM PERFORMED THAT REVEALED THE PRESENCE OF RIGHT ATRIAL MASS, WHICH DR. (B)(6), M.D. QUALIFIED AS "LIKELY A THROMBUS AT THE TIP OF THE PORT." UPON INFORMATION AND BELIEF, ON OR ABOUT (B)(6) 2017, PLAINTIFF WAS TRANSFERRED TO THE (B)(6) MEDICAL CENTER. THE AFOREMENTIONED FACILITY, PLAINTIFF HAD CARDIAC MRI PERFORMED. THE CARDIAC MRI AT ISSUE SHOWED T

  Patient problems: Inflammation; Thrombosis/Thrombus

  MAUDE report 21400029 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  ON OR ABOUT ON (B)(6) 2015, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER: CT80STPD AND LOT NUMBER: 4879755. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6) MAJOR HOSPITAL IN (B)(6), FOR ONGOING CHEMOTHERAPY TREATMENT. ON OR ABOUT ON (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) MAJOR HOSPITAL FOR A PORT STUDY. THE STUDY REVEALED THAT CONTRAST EXTRAVASATED ALONG THE PROXIMAL MIDPORTION OF THE CATHETER TUBING, INDICATING THAT THE PLAINTIFF'S PORT HAD FRACTURED AND REQUIRED REMOVAL. ON OR ABOUT ON (B)(6) 2015, PLAINTIFF UNDERWENT PORT REVISION, DURING WHICH A REPLACEMENT ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER: CT80STPD AND LOT NUMBER: 4921248, WAS IMPLANTED BY DR. (B)(6) M.D. AT (B)(6) MAJOR HOSPITAL FOR ONGOING CHEMOTHERAPY TREATMENT.

  Patient problems: Extravasation

  MAUDE report 21399175 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT, MODEL NUMBER: H7887CT80STPD0 AND LOT NUMBER: 5715892. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6) HOSPITAL IN (B)(6) FOR CHEMOTHERAPY TREATMENT. ON OR ABOUT (B)(6) 2022, PLAINTIFF EXPERIENCED PAIN AND SWELLING AT THE PORT SITE AND UNDERWENT A THROMBOSIS WORKUP AT (B)(6) HOSPITAL. A DOPPLER STUDY INDICATED THAT PLAINTIFF WAS NOT EXPERIENCING A DEEP VENOUS THROMBOSIS; HOWEVER, FLUID WAS OBSERVED ALONG THE MEDIAL MARGIN OF THE PORT. ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT A PORT STUDY AT (B)(6) HOSPITAL AFTER BEING DIAGNOSED WITH CELLULITIS. THE STUDY REVEALED SIGNIFICANT SUBCUTANEOUS EDEMA. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL FOR PORT REMOVAL DUE TO A PORT SITE INFECTION. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND REQUIRED REMOVAL. CULTURES FROM THE CATHETER TIP TESTED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. THE DEFECTIVE DEVICE 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 UNDERGON

  Patient problems: Bacterial Infection; Cellulitis; Swelling/ Edema

  MAUDE report 21180675 ↗
• InjuryJan 8, 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, REFERENCE NUMBER CT80STPD, LOT NUMBER 5152534. THE DEVICE WAS IMPLANTED BY (B)(6), M.D., AT (B)(6) HOSPITAL, IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY FOR HER CANCER. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION THAT CAUSED HOSPITALIZATION.

  Patient problems: Unspecified Infection

  MAUDE report 21102867 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT PRODUCT, CATALOG NUMBER CT80STPD; LOT NUMBER 4969640. UPON INFORMATION AND BELIEF, THE DEVICE'S DESCRIPTION IS AS FOLLOWS: SMARTPORT CT SINGLE TITANIUM PORT SYSTEM. THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6), MD., AT (B)(6), IN (B)(6), FOR LONG-TERM VENOUS ACCESS FOR PLAINTIFF'S CHEMOTHERAPY AND BLOOD DRAWS. ON OR ABOUT (B)(6) 2022, A CT NECK WITH CONTRAST, ADMINISTERED TO (B)(6), REVEALED THE PRESENCE OF RIGHT INTERNAL JUGULAR VEIN THROMBOPHLEBITIS. THE PLAINTIFF'S CONDITION WAS DETERMINED TO BE ASSOCIATED WITH HIS SMARTPORT. THE PLAINTIFF'S MEDICAL TEAM FOUND THAT PLAINTIFF DEVELOPED THROMBOSIS OF THE LOWER CERVICAL RIGHT INTERNAL JUGULAR VEIN WITH INFLAMMATORY CHANGES IN HIS CERVICAL SOFT TISSUES, WHICH QUALIFIED HIS CONDITION AS THROMBOPHLEBITIS. ON (B)(6) 2022, (B)(6) RETURNED TO (B)(6) IN (B)(6), FOR REMOVAL OF THE DEFECTIVE PORT-A-CATH, WHICH, UPON INFORMATION AND BELIEF, WAS REMOVED BY DR. (B)(6), MD, A RADIOLOGIST. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, (B)(6) HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECO

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20784599 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF AN IMPLANTABLE VASCULAR ACCESS DEVICE AT (B)(6) HOSPITAL, WHERE HE WAS IMPLANTED WITH AN ANGIODYNANMICS SMARTPORT PORT, REF # UPN H787CTB05STPO0, LOT #. 5612502. DEFENDANT MANUFACTURED, SOLD, AND/OR DISTRIBUTED THE SMARTPORT TO PLAINTIFF, THROUGH HIS DOCTORS, TO BE USED FOR DELIVERY OF DRUG THERAPIES. THE DEVICE MALFUNCTIONED, AND ON (B)(6) 2020, PLAINTIFF UNDERWENT SURGERY TO REMOVE THE SMARTPORT. THE PORT WAS FOUND TO HAVE LEAKED IN THE LEFT SUBCLAVIAN POSITION. 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 AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, 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 20724246 ↗
• InjuryNov 18, 2024Adverse 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 THE ANGIODYNAMICS SMARTPORT, MODEL NUMBER: H787CT80STPD0 AND LOT NUMBER: 5567178. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6) FOR LONG TERM IV ACCESS. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HIMSELF TO (B)(6) HOSPITAL IN (B)(6) WITH COMPLAINTS OF FATIGUE AND WEAKNESS. PLAINTIFF'S BLOOD CULTURES WERE DRAWN AND WERE POSITIVE. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT HE DEVELOPED AN INFECTION AND THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT IT NEEDED TO BE REMOVED. ON OR ABOUT (B)(6) 2021, THE DEFECTIVE DEVICE WAS REMOVED AT (B)(6) HOSPITAL. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Fatigue; Muscle Weakness/Atrophy; Unspecified Infection

  MAUDE report 20710213 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2023, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 5764975. THE DEVICE WAS IMPLANTED BY AMBARISH PERVAJE BHAT, M.D., AT HARRY S. TRUMAN MEMORIAL VETERANS' HOSPITAL IN COLUMBIA, MISSOURI, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT JULY 17, 2023, PLAINTIFF PRESENTED HIMSELF TO THE EMERGENCY DEPARTMENT AT LAKE REGIONAL HEALTH SYSTEM IN OSAGE BACH, MISSOURI WITH COMPLAINTS OF WEAKNESS AND FEVER. BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT THE DEFECTIVE PORT HAD TO BE REMOVED. ADDITIONALLY, PLAINTIFF'S PORT HAD ERODED THROUGH HIS SKIN. ON OR ABOUT (B)(6) 2023, PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6) AT LAKE REGIONAL HEALTH SYSTEM. AFTER PORT REMOVAL, PLAINTIFF'S PORT WAS SENT TO FOR CULTURING, AND THE RESULTS WERE POSITIVE FOR METHICILLIN- RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND

  Patient problems: Bacterial Infection; Skin Erosion

  MAUDE report 20509492 ↗
• DeathOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF'S DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER H787CT80STPD0, LOT NUMBER 5733844. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) HOSPITAL IN (B)(6), FOR ADMINISTRATION OF CHEMOTHERAPY. DECEDENT PRESENTED TO (B)(6) HOSPITAL WITH COMPLAINTS OF FEVER AND WEAKNESS. IT WAS DETERMINED BY DECEDENT'S MEDICAL TEAM THAT HE HAD AN INFECTION CAUSED BY THE SMARTPORT AND THAT THE DEFECTIVE DEVICE HAD TO BE REMOVED. DECEDENT'S DEFECTIVE SMARTPORT WAS REMOVED. ON OR ABOUT (B)(6), 2022, DECEDENT PASSED AWAY. THE DEATH CERTIFICATE LISTS SEPSIS AS THE CAUSE OF DEATH.

  Patient problems: Fever; Muscle Weakness/Atrophy; Sepsis

  MAUDE report 20440859 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2013, PLAINTIFF (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER (B)(4), LOT NUMBER 588538. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), DUE TO POOR IV ACCESS. ON OR ABOUT APRIL 3, 2015, PLAINTIFF (B)(6) BROUGHT HIS SON, PLAINTIFF (B)(6), TO THE CLINIC AT (B)(6) HOSPITAL WITH COMPLAINTS OF PURULENT MATERIAL AT THE PORT SITE. BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR PSEUDOMONAS AERUGINOSA AND KLEBSIELLA PNEUMONIAE. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION 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), M.D., AT (B)(6) HOSPITAL. 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; Pain

  MAUDE report 19949948 ↗
• MalfunctionAug 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A PATIENT'S CONTACT REPORTED AN ISSUE WITH A SINGLE TITANIUM CT VTX PORT W POLY CATH. THE FOLLOWING WAS REPORTED: "(B)(6) HAD A SMART PORT INSERTED IN HIS LEFT CHEST AREA ON (B)(6), 2023. PORT : UPN H787CT80STPD0 LOT 5743899. THE PORT HAS NOT BEEN WORKING SINCE MAY 2023. THE FLAP AT THAT TIME WAS NOT WORKING CORRECTLY. THIS WAS STILL OCCURING IN JUNE 2023. THE PORT AFTER THEN WAS NOT WORKING FOR THE NURSES TO DRAW BLOOD FROM THIS PORT. (B)(6) HAS BEEN GOING THROUGH MUCH PAIN AND SUFFERING NOW DUE TO HIS VEINS COLLAPSING. HE NEEDS TO KNOW WHAT YOUR COMPANY CAN DO FOR HIM SINCE THE REASON HE GOT THE PORT WAS TO AVOID USING HIS VEINS FOR LABS EVERY WEEK AS HE IS GOING THROUGH CANCER TREATMENTS. NOW HE HAS TO GO THROUGH ANOTHER SURGERY TO REMOVE YOUR SMART PORT AND INSERT ANOTHER PORT. THIS OF COURSE WILL NOW CAUSE HIM MORE PAIN AND SUFFERING. ONCE AGAIN HE NEEDS TO KNOW WHAT CAN BE DONE FOR HIM. " ADDITIONAL INFORMATION OBTAINED: "WILLIAM WAS NOT ABLE TO GO THROUGH ANOTHER SURGERY FOR REMOVAL OR FOR A NEW PORT YET DUE TO HIS HEALTH ISSUES. HIS ORIGINAL PORT IS NOT ABLE TO BE REUSED AND A NEW PORT HAS TO BE INSTALLED ON HIS RIGHT SIDE. THESE SURGERIES ARE VERY DELICATE AND HIS VEINS AR

  Patient problems: Failure of Implant; Pain

  MAUDE report 19918995 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, A PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, SINGLE TITANIUM CT VTX PORT W POLY CATH. THE DEVICE WAS IMPLANTED BY (B)(6), M.D., AT (B)(6) IN MEXICO, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. SEVERAL MONTHS LATER, ON OR ABOUT (B)(6) 2019, THE PATIENT PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL WITH COMPLAINTS OF WEAKNESS AND FEVER. BLOOD CULTURES WERE DRAWN AND WERE POSITIVE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS. THE PATIENT'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND THAT THE DEFECTIVE PORT HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2019, THE DEFECTIVE PORT WAS REMOVED BY (B)(6). AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, THE PATIENT REPORTED HAVING EXPERIENCING SIGNIFICANT MENTAL AND PHYSICAL 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; Fever; Muscle Weakness/Atrophy

  MAUDE report 19143150 ↗
• MalfunctionMar 6, 2024Fracture; Fracture

  AN ANGIODYNAMICS SENIOR CLINICAL SPECIALIST REPORTED AN ISSUE WITH A SINGLE TITANIUM CT VTX PORT W POLY CATH. IT WAS REPORTED THAT A PORT CATHETER FRACTURE WAS DISCOVERED DURING PORT REMOVAL AND THE FRACTURED SEGMENT REMAINS IN THE PATIENT. THE SURGEON DETERMINED THAT THE FRAGMENT WILL REMAIN IN SITU AND THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846560 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED PATIENTS HAVE EXPERIENCED DESHISSANCE OF THEIR SKIN, WHERE THE PORT CATHETER WAS TUNNELED. IT WAS REPORTED THAT THIS HAS OCCURRED MULTIPLE TIMES, TO DIFFERENT PATIENTS, WITH DIFFERENT PROVIDERS. THIS ISSUE HAS BEEN FOUND TO OCCUR 30+ DAYS, PAST INITIAL PORT INSERTION AND ARE NOT CLEAR INFECTIONS BUT MORESO EROSION AND REDNESS TRACKING UP THE CATHETER. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, MINIMAL DETAILS WERE ONLY PROVIDED FOR TWO PATIENTS, ONE WHOM EXPIRED FROM SEPSIS AND ANOTHER WHO IS EXPERIENCING EROSION AND REDNESS TRACKING UP THE CATHETER. REFERENCE: (B)(4) (1319211-2024-00011) FOR SEPSIS DEATH AND (B)(4) (1319211-2024-00012) FOR EROSION AND REDNESS TRACKING UP THE CATHETER.

  Patient problems: Erythema; Skin Erosion

  MAUDE report 18752258 ↗
• DeathFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED PATIENTS HAVE EXPERIENCED DESHISSANCE OF THEIR SKIN, WHERE THE PORT CATHETER WAS TUNNELED. IT WAS REPORTED THAT THIS HAS OCCURRED MULTIPLE TIMES, TO DIFFERENT PATIENTS, WITH DIFFERENT PROVIDERS. THIS ISSUE HAS BEEN FOUND TO OCCUR 30+ DAYS, PAST INITIAL PORT INSERTION AND ARE NOT CLEAR INFECTIONS BUT MORESO EROSION AND REDNESS TRACKING UP THE CATHETER. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ALL ADDITIONAL INFORMATION, MINIMAL DETAILS WERE ONLY PROVIDED FOR TWO PATIENTS; ONE WHOM EXPIRED FROM SEPSIS AND ANOTHER WHO IS EXPERIENCING EROSION AND REDNESS TRACKING UP THE CATHETER.

  Patient problems: Pocket Erosion; Sepsis; Wound Dehiscence

  MAUDE report 18747660 ↗
• MalfunctionDec 19, 2023Material Puncture/Hole; Material Puncture/Hole

  ANGIODYNAMICS RECEIVED A VOLUNTARY USER MEDWATCH, REFERENCE (B)(6) A RISK MANAGER REPORTED ISSUES WITH TWO SINGLE TITANIUM CT VTX PORTS W POLY CATH. THE FOLLOWING WAS REPORTED: "PATIENT ARRIVED TO THE CLINIC TO RECEIVE CHEMOTHERAPY. PATIENT HERE FOR FOLFOX C4 D15. PATIENT AMBULATES TO INFUSION SUITE WITHOUT ASSISTANCE. IDENTITY CONFIRMED USING TWO PATIENT IDENTIFIERS: DOB AND FULL NAME. LABS WNL. PATIENT SEEN BY PROVIDER PRIOR TO TREATMENT. PORT ACCESS BY THIS REGISTERED NURSE (RN) WITH STERILE TECHNIQUES AS PORT WAS FLUSHED WITH NORMAL SALINE PATIENT GRIMACED DUE TO DISCOMFORT. PATIENT REPOSITIONED WITH SAME RESULTS. CHARGE NURSE AT CHAIRSIDE TO ASSESS PORT SITE. PATIENT AGAIN HAS DISCOMFORT WITH SALINE BEING PUSHED IN PORT. PORT DE ACCESSED WITH HUBER NEEDLE INTACT. FLUID NOTED COMING FROM PORT SITE. PORT RE ACCESSED. PATIENT STILL HAS DISCOMFORT AND SWELLING NOTED AROUND PORT SITE. PORT DE ACCESSED WITH HUBER NEEDLE INTACT. PLAN OF CARE EXPLAINED TO PATIENT AND QUESTIONS ANSWERED. PATIENT LEFT IN STABLE CONDITION AND SENT TO RADIOLOGY DEPARTMENT FOR FLUOROSCOPY. PATIENT HAD PORT REMOVED, DEEMED TO BE A MALFUNCTIONING PORT. NEW PORT IMPLANTED. PATIENT SEEN TO HAVE A NEW PORT IMPL

  Patient problems: Fluid Discharge; Pain; Swelling/ Edema

  MAUDE report 18357607 ↗
• InjuryOct 10, 2023Fracture; Migration; Fracture; Migration

  A PATIENT REPORTED EXPERIENCING AN ISSUE WITH AN ANGIODYNAMICS PORT. THE FOLLOWING WAS REPORTED VIA THE CUSTOMER SERVICE "CONTACT US NOW" SUBMISSION BOX: "MY NAME IS [REDACTED], I AM A RECEIVER OF ONE OF YOUR MEDICAL PORTS . DURING THE REMOVAL OF THE PORT AFTER THE CANCER WAS IN REMISSION, THE TIP OF YOUR PORT, BROKE OFF AND IS NOW INSIDE MY HEART ON THE SUPERIOR VENA CAVA AND RIGHT VENTRICLE OF MY HEART. I NEED TO SPEAK TO SOMEONE IN THE LEGAL DEPART MENT. OR ATLEAST SOMEONE IN YOUR ADMINISTRATIVE DEPARTMENT. AT (B)(6) WHERE IM CURRENTLY UNDERGOING TREATMENT DO TO SOME INFECTION THAT THIS CAUSED. (B)(6) IM IN (B)(6) " FURTHER FOLLOW UP DETERMINED THAT THE DEVICE WAS EXPLANTED IN (B)(6) OF 2018. THE TIP FRAGMENT HAS BEEN IN SITU SINCE THIS DATE AS IT WAS DETERMINED THAT IT WOULD BE TOO RISKY TO REMOVE. PATIENT HAS REPORTED EXPERIENCING ONGOING INFECTIONS, INCLUDING ENDOCARDITIS, AS A RESULT OF THE FRAGMENT. PATIENT WAS UNABLE TO PROVIDE BRAND NAME, UPN OR LOT NUMBER OF DEVICE.

  Patient problems: Infiltration into Tissue; Unspecified Infection

  MAUDE report 17907089 ↗
• MalfunctionJul 17, 2023Fracture; Fracture

  HENSLEY LEGAL GROUP, PC., A LAW GROUP, NOTIFIED ANGIODYNAMICS OF AN INCIDENT REGARDING A SMARTPORT FROM A SINGLE TITANIUM CT VTX PORT W POLY CATH KIT. THE DEVICE WAS IMPLANTED BY (B)(6) AT (B)(6)., FOR THE PURPOSE OF ONGOING MEDICAL TREATMENT ON (B)(6) 2021. ON OR ABOUT (B)(6)2021, THE SMARTPORT [CATHETER] FRACTURED, CAUSING SEVERE INJURY TO PLAINTIFF. ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT SURGERY WITH (B)(6) AT IU (B)(6), TO REMOVE THE SMARTPORT AND THE FRACTURED CATHETER. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS REPORTEDLY 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 FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 17334291 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  AN END-USER REPORTED THAT A PATIENT'S SMARTPORT THAT HAD INITIALLY BEEN PLACED ON (B)(6)2022, WAS HAVING THE DEVICE REMOVED DUE TO THE COMPLETION OF CHEMOTHERAPY TREATMENT. A PRE-PROCEDURE X-RAY DETERMINED THE CATHETER HAD DETACHED FROM THE PORT AND MIGRATED TO RIGHT ATRIUM (PREVIOUS X-RAY FROM (B)(6) 2022 HAD CONFIRMED THE PORT WAS STILL ATTACHED.). THE PORT WAS REMOVED AND CATHETER WAS REMOVED USING A SNARE VIA GROIN ACCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17070864 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A REACTION TO A SMARTPORT FROM A TANDEM SINGLE TITANIUM CT VTX PORT W POLY CATH KIT, POST PROCEDURE. THE PATIENT PRESENTED WITH A LOCALIZED ALLERGIC REACTION AT THE BASE OF THE RIGHT NECK WHERE THE VEIN ACCESS OCCURRED FOR THE IMPLANTED PORT. THE PATIENT REPORTED REACTION STARTED 1-2 DAYS AFTER THE IMPLANT. ON (B)(6) 2023, THE PATIENT WAS SEEN AND STARTED ON IV KEFLEX AT VASCULAR CLINIC RADIOLOGY PARTNERS TETON RADIOLOGY IN IDAHO FALLS, ID. ON A SUBSEQUENT FOLLOW UP VISIT, ON (B)(6) 2023, THE PATIENT PRESENTED WITH MORE ERYTHEMA AND PRURITIS THAT WAS TRACKING FROM NECK (INSERTION VEIN SITE) TOWARDS PORT POCKET. THE PATIENT WAS PROVIDED TREATMENT OF ORAL ZYRTEC, BENADRYL, PEPCID, AND TOPICAL STEROIDAL, BUT THE REACTION CONTINUED. THE PATIENT HAS ONE KNOWN ANTIBIOTIC ALLERGY, BUT IS UNAWARE OF THE NAME. NO OTHER SYMPTOMS WERE OBSERVED SUCH AS BLISTERS, SYSTEMIC ALLERGY, AND ANAPHYLACTIC SHOCK. NO IV INFUSATES OR MEDICATIONS WERE USED POST PORT IMPLANT; HEPARINIZED SALINE WAS USED TO LOCK THE PORT CATHETER. HEPARIN CONCENTRATION IS UNKNOWN. THE PORT WAS IMPLANTED FOR CHEMOTHERAPY DUE TO CA. THE PORT POCKET AND INCISION SITE CLEAN DRY AND INTA

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16453058 ↗
• MalfunctionJun 7, 2022Fracture; Fracture

  A PATIENT HAD A SMARTPORT SINGLE TITANIUM CT VTX PORT. IT WAS REPORTED THE PORT CATHETER HAD CRACKED AND FRACTURED INSIDE THE PATIENT. THE PORT WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14621095 ↗
• MalfunctionJun 7, 2022Fracture; Fracture

  A PATIENT HAD A SMARTPORT SINGLE TITANIUM CT VTX PORT PLACED ON (B)(6) 2022. IT WAS REPORTED THE PORT CATHETER HAD CRACKED AND FRACTURED INSIDE THE PATIENT. THE PORT WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14621020 ↗
• MalfunctionMay 26, 2022Fracture; Fracture

  A PATIENT HAD A SMARTPORT SINGLE TITANIUM CT VTX PORT PLACED ON (B)(6) 2022. THE PORT WAS NOTICED TO BE NONFUNCTIONAL DUE TO NOT ASPIRATING ON (B)(6) 2022. THE PATIENT WAS SENT TO ANOTHER FACILITY TO HAVE CXR PERFORMED, AT WHICH TIME IT WAS NOTED THE PORT CATHETER HAD FRACTURED INTO THREE PIECES. THE PORT BODY WAS IN SUBCUTANEOUS POCKET IN THE RIGHT CHEST, AND THE CATHETER FRAGMENTS WERE IN RIGHT NECK AND THE REST IN THE INFERIOR VENA CAVA. DUE TO THIS ISSUE, THE PORT WAS REMOVED IN MCI BUILDING ON (B)(6) 2022, AND THE CATHETER FRAGMENTS WERE REMOVED IN MCVI BUILDING ON (B)(6) 2022. IT IS UNKNOWN IF THE PORT HAD BEEN REPLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14517830 ↗

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