Smart Port CTRecalls & reported problems across all models

Angiodynamics, Inc. · 36 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 479
Deaths reported: 14
Injuries reported: 265
Recalls: 0

We found 36 models of Smart Port CT by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 479 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2017 and Sep 28, 2026 — classified as 14 deaths, 265 injuries, 200 malfunctions.

The most frequently reported specific device problem is “Fracture” (137 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

Most reported Smart Port CT problems

Device problems

Adverse Event Without Identified Device or Use Problem156
Fracture137
Detachment of Device or Device Component55
Difficult to Remove50
Crack32
Fluid/Blood Leak29
Infusion or Flow Problem22
Leak/Splash13

Patient problems

No Clinical Signs, Symptoms or Conditions74
No Known Impact Or Consequence To Patient64
Foreign Body In Patient57
Device Embedded In Tissue or Plaque51
Bacterial Infection45
Pain39
Thrombosis/Thrombus34
Sepsis32

Smart Port CT models

36 models, most reported first. Each model has its own page with its reports, recalls and device details.

Smart Port CT CT80STPD
Set, administration, intravascular
2 deaths73 reports
Smart Port CT CT66LTPD
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 death59 reports
Smart Port CT CT80STPD-VI
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 death54 reports
Smart Port CT H787CT80STPD0
Set, administration, intravascular
2 deaths49 reports
Smart Port CT H787CT80STPDVI1
Set, administration, intravascular
1 death43 reports
Smart Port CT CT75STSD
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
23 reports
Smart Port CT H787CT96STSD0
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
20 reports
Smart Port CT CT96STSD
Set, administration, intravascular
18 reports
Smart Port CT H787CT75STSD0
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 death14 reports
Smart Port CT CT75STSA
Set, administration, intravascular
14 reports
Smart Port CT H787CT66LTPD0
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
13 reports
Smart Port CT H787CT66LTPDVI1
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 death13 reports
Smart Port CT CT66LTPD-VI
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
9 reports
Smart Port CT H787CT96STSDVI1
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
2 deaths8 reports
Smart Port CT CT80STPA-VI
Set, administration, intravascular
8 reports
Smart Port CT CT80STPD-NF
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
6 reports
Smart Port CT CT80STPD-NFVI
Set, administration, intravascular
6 reports
Smart Port CT CT96STSD-VI
Set, administration, intravascular
6 reports
Smart Port CT CT66PTPD
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 death5 reports
Smart Port CT CT96STSA
Set, administration, intravascular
5 reports
Smart Port CT H787CT75STSDVI1
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
4 reports
Smart Port CT H787CT75STSA0
Set, administration, intravascular
3 reports
Smart Port CT H787CT80STPDNF0
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
3 reports
Smart Port CT H787CT96STSA0
Set, administration, intravascular
3 reports
Smart Port CT CT66PTPD-VI
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
3 reports
Smart Port CT CT80STPA
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
3 reports
Smart Port CT H787CT66PTPD0
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
2 reports
Smart Port CT H787CT80STPA0
Set, administration, intravascular
2 reports
Smart Port CT H787CT96STSDNF0
Set, administration, intravascular
2 reports
Smart Port CT CT75STSD-VI
Set, administration, intravascular
2 reports
Smart Port CT H787CT66LTPDNF0
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 report
Smart Port CT H787CT66PTPDVI1
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 report
Smart Port CT H787CT80STPAVI1
Set, administration, intravascular
1 death1 report
Smart Port CT H787CT80STPDNFVI1
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 report
Smart Port CT H787CT96STSAVI1
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 death1 report
Smart Port CT CT96STSD-NF
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
1 report

Recent Smart Port CT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionSep 28, 2026Fracture; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923679 ↗
InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Chest Pain; Chills; Confusion/ Disorientation; Fatigue; Fever; Medical device site infection
MAUDE report 50909990 ↗
InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50909966 ↗
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Prior to 2024, Plaintiff was diagnosed with breast cancer. Plaintiff's cancer treatment included chemotherapy. In order to administer chemotherapy medications, Plaintiff's physicians placed a port catheter in her chest.On or about (b)(6) 2024, Plaintiff underwent placement of an Angio Dynamics "Smart Port," identified as follows: UPN: H787CT66LTPD0; Lot Number: Al624008; Manufacturer: Angio Dynamics, Inc. The Smart Port was placed at (b)(6) for purposes of administering Plaintiff's chemotherapy.On or about (b)(6) 2024, Plaintiff presented to (b)(6) with discomfort extending from the left side of her neck to her ear and shoulder region, down to the axilla, as well as a sensation of pressure at the site where the port had been placed. Plaintiff was diagnosed with acute embolism and thrombosis of the left subclavian vein, left axillary vein, and left internal jugular vein. (b)(4)- 1319211-2026-00322).On or about (b)(6) 2024, Plaintiff was diagnosed with deep vein thrombosis ("DVT") and continued treatment with Eliquis, 5 mg. (b)(4)- 1319211-2026-00323).On or about (b)(6) 2024, Plaintiff underwent removal of the Smart Port at (b)(6) .
Patient problems: Ear Pain; Embolism/Embolus; Implant Pain; Neck Pain; Thrombosis/Thrombus
MAUDE report 50876767 ↗
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Prior to 2024, Plaintiff was diagnosed with breast cancer. Plaintiff's cancer treatment included chemotherapy. In order to administer chemotherapy medications, Plaintiff's physicians placed a port catheter in her chest.On or about (b)(4) 2024, Plaintiff underwent placement of an Angio Dynamics "Smart Port," identified as follows: UPN: H787CT66LTPD0; Lot Number: Al624008; Manufacturer: Angio Dynamics, Inc. The Smart Port was placed at (b)(6) in (b)(6) for purposes of administering Plaintiff's chemotherapy.On or about (b)(6) 2024, Plaintiff presented to (b)(6) with discomfort extending from the left side of her neck to her ear and shoulder region, down to the axilla, as well as a sensation of pressure at the site where the port had been placed. Plaintiff was diagnosed with acute embolism and thrombosis of the left subclavian vein, left axillary vein, and left internal jugular vein. (b)(4) ,1319211-2026-00322).On or about (b)(6) 2024, Plaintiff was diagnosed with deep vein thrombosis ("DVT") and continued treatment with Eliquis, 5 mg. (b)(4),1319211-2026-00323).On or about (b)(6) 2024, Plaintiff underwent removal of the Smart Port at (b)(6) .
Patient problems: Thrombosis/Thrombus
MAUDE report 50876766 ↗
MalfunctionSep 24, 2026Fluid/Blood Leak; No Flow
On or about (b)(6)2024, Plaintiff underwent placement of an AngioDynamics SmartPort product, reference number H787CT80STPDVI1, lot number A4123002. The device was implanted by(b)(6) at (b)(6) for vascular access.On or about (b)(6)2024, Plaintiff's port was non-functional and noted to be leaking.On or about (b)(6)2024, Plaintiff's SmartPort was removed by (b)(6) at (b)(6) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876708 ↗
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2024, Plaintiff underwent placement of an Angio Dynamics Smart Port product, reference number H787CT80STPDVI1, lot number A4423039. The device was implanted by Dr. (b)(6), MD at (b)(6) for the purpose of providing vascular access.On or about (b)(6) 2024, Plaintiff was diagnosed with an infection, and port removal was recommended.On or about (b)(6) 2024, Plaintiff's port was removed by Dr. (b)(6), MD at (b)(6).
Patient problems: Unspecified Infection
MAUDE report 50876707 ↗
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2024, Plaintiff underwent placement of an Angio Dynamics Smart Port port catheter product, with model number H787CT80STPDNF0.The Smart Port device was implanted by Dr. (b)(6), at (b)(6) in (b)(6), for the principal purpose of medication administration for Plaintiff's Crohn's disease.On or about (b)(6) 2024, Plaintiff presented to Dr. (b)(6) at (b)(6) who diagnosed the Plaintiff with bacteremia.On or about (b)(6) 2024, Plaintiff presented to (b)(6) at (b)(6) to have the Smart Port removed due to the Plaintiff's infection.
Patient problems: Bacteremia
MAUDE report 50876706 ↗
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2017, Plaintiff underwent left internal jugular placement of an Angio Dynamics Smart Port CT port catheter product, with model number CT66LTPD, and lot number 5207252. The Smart Port was implanted by Dr. (b)(6), M.D., at (b)(6) .On or about (b)(6) 2020, while hospitalized at (b)(6) for cholangitis, blood was drawn from Plaintiff's Smart Port, and the culture results were positive for infection. Based on these findings, removal of the Smart Port was recommended.On or about (b)(6) 2020, while hospitalized at (b)(6) , Plaintiff underwent removal of the Smart Port secondary to bacteremia. The removal procedure was performed by Dr. (b)(6), M.D.On or about (b)(6) 2020, positive blood cultures indicated the presence of klebsiella variicola.
Patient problems: Bacteremia
MAUDE report 50876705 ↗
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2022, Plaintiff underwent placement of an AngioDynamics SmartPort product, reference number (b)(4), and lot number 5730877. The device was implanted by Dr. (b)(6) MD (b)(6) in (b)(6) for the purpose of providing Chemotherapy.On or about (b)(6) 2022 Plaintiff was diagnosed with an infection, and port removal was recommended.On or about (b)(6)2022, Plaintiff's infected port was removed by Dr. (b)(6) MD at (b)(6).
Patient problems: Bacterial Infection
MAUDE report 50863275 ↗
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
On (b)(6) 2025, Plaintiff underwent placement of an AngioDynamics SmartPort port catheter product, with model number H787CT96STSA0, and lot number 5842032. This SmartPort devices consisted of a port body and a polyurethane catheter. The SmartPort device was implanted by Dr. (b)(6)MD., at (b)(6) Medical Center, (b)(6), for the purpose of ongoing chemotherapy treatment.On (b)(6) 2025, Plaintiff (b)(6) presented to (b)(6) Medical Center, (b)(6), with complaints of chest pain, generalized weakness, and sinus tachycardia. A sepsis alert was activated and a sepsis protocol initiated, after which Plaintiff was diagnosed with sepsis.
Patient problems: Chest Pain; Muscle Weakness/Atrophy; Sepsis; Tachycardia
MAUDE report 50863274 ↗
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2024, Plaintiff underwent placement of an AngioDynamics SmartPort port catheter product, with model number H787CT80STPD0, and lot number 5821731. This SmartPort device consisted of a port body and a polyurethane catheter.The SmartPort device was implanted by Dr. (b)(6) MD. under the supervision of Dr. (b)(6) MD., at (b)(6), for the purpose of ongoing chemotherapy treatment.On or about (b)(6) 2025, Plaintiff (b)(6) presented to (b)(6) Hospital in (b)(6), with complaints of fever since that morning. She was admitted with concern for neutropenic fever with sepsis and hospital- acquired pneumonia. Blood cultures from the port were positive for Staphylococcus epidermidis likely contaminant at port site. Blood cultures drawn on (b)(6) 2025, from the port site, were positive for Staphylococcus epidermidis in 1 of 2 bottles. Found to have methicillin resistant Staphylococcus epidermidis bacteria in one bottle.On or about (b)(6) 2025, medical recommendation was to discontinue vancomycin given negative MRSA nares swab. Continue cefepime. Discontinue blood culture collection. The assessment at the time was that patient is colonized or contaminant at port site vs low concern
Patient problems: Fever; Pneumonia; Sepsis
MAUDE report 50863273 ↗
InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2018, Plaintiff under placement of an Angiodynamics SmartPort Injectable port catheter device, with model number H787CT80STPD0, and lot number 5072844. The device was implanted by Dr. (b)(6) at (b)(6) Hospital, Ohio for chemotherapy administration to treat Plaintiff's cancer.On or about (b)(6), 2018, Plaintiff presented to the (b)(6) Hospital, Ohio for removal of the port catheter and a preoperative CT scan, she was suffering from shortness of breath.On or about (b)(6), 2018, Plaintiff's defective port was removed by Dr. (b)(6), (b)(6) Hospital, Ohio.
Patient problems: Dyspnea
MAUDE report 50201619 ↗
InjuryAug 11, 2026Obstruction of Flow
On or about (b)(6) 2016, Plaintiff (b)(6) underwent an insertion of a right internal jugular vein central venous access port of an AngioDynamics SmartPort port catheter product, model number CT96STSD, lot number 4987773. Upon information and belief, this SmartPort device consisted of a port body and a silicone catheter. The SmartPort was implanted at (b)(6). On or about (b)(6) 2016, Plaintiff presented to (b)(6) Hospital in (b)(6) for right arm swelling and discomfort, where she was ultimately diagnosed with right upper extremity deep vein thrombosis ("DVT") caused by her SmartPort device. Her treaters did not recommend removal of the device at that time, and instead Plaintiff was treated by being placed on blood thinners for 6 months. Thereafter, the SmartPort device remained implanted, and Plaintiff did not suffer further problems until on or about (b)(6) 2019, when she presented to Lake Regional Hospital for right chest and neck pain caused by her Smart Port device, which was occluded and not working properly. Her SmartPort device was thereafter surgically removed on or about (b)(6) 2019, at (b)(6) Hospital.
Patient problems: Chest Pain; Discomfort; Neck Pain; Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 50201616 ↗
DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem
On or about (b)(6) 2021, Decedent Plaintiff underwent placement of an AngioDynamics SmartPort product, reference number (b)(4), and lot number 5676112. The device was implanted by Dr. (b)(6), MD and (b)(6), MD at (b)(6) for the purpose of providing chemotherapy.On or about (b)(6) 2023, Decedent Plaintiff was diagnosed with an infection.On or about (b)(6) 2023, Decedent Plaintiff presented back to the hospital and was diagnosed with severe neutropenia.On (b)(6) 2023, Decedent Plaintiff passed away due to complications from the direct and proximate effects of his port infections.
Patient problems: Low White Blood Cell Count; Unspecified Infection
MAUDE report 50201604 ↗

Other Angiodynamics, Inc. products

All Angiodynamics, Inc. devices →

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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