📋 FDA Reference
FlowTriever Retrieval Aspiration System
Summary: The FlowTriever Retrieval Aspiration System is a medical device used for mechanical thrombectomy in patients with pulmonary embolism. It is primarily used by interventional radiologists and cardiologists to remove clots from the pulmonary arteries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K201541 ↗
Decision Date ?
December 4, 2020
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
14 studies
The FlowTriever Retrieval Aspiration System, manufactured by Inari Medical, was cleared through the FDA 510k pathway on December 4, 2020. It is a Class 2 medical device.
What It Is
The FlowTriever Retrieval Aspiration System is a mechanical thrombectomy device designed to remove thrombi from the pulmonary arteries. It works by using large-bore catheters to aspirate and retrieve clots, providing a minimally invasive option for treating pulmonary embolism. The system is designed to reduce clot burden without the need for thrombolytic drugs, which can be beneficial in patients at risk for bleeding.
FDA-Cleared Indications
- Removal of thrombus from the pulmonary arteries in patients with pulmonary embolism.
- Mechanical thrombectomy using aspiration and clot-retrieval components without requiring thrombolytic medication as part of the device procedure.
Clinical Applications
- Catheter-based thrombectomy for pulmonary embolism.
- Removal of clot from the main, lobar, or segmental pulmonary arteries when mechanical clot removal is clinically indicated.
- Treatment of selected intermediate- or high-risk pulmonary embolism patients in a hospital-based endovascular procedure.
- Mechanical clot removal when avoiding or limiting thrombolytic medication is clinically appropriate.
Reported off-label uses
- Mechanical thrombectomy for deep vein thrombosis in peripheral veins, depending on the specific device configuration, anatomy, and applicable labeling.
- Thrombectomy of thrombosed dialysis fistulas or grafts using compatible FlowTriever components, when performed off label.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The system uses large-bore aspiration and retrieval catheters; catheter and sheath selection depends on vessel size, clot burden, and patient anatomy.
- The procedure requires venous access, commonly through the common femoral vein, with fluoroscopic or other appropriate imaging guidance.
- Operators should be experienced with large-bore venous access, aspiration thrombectomy, anticoagulation, and management of access-site bleeding or pulmonary vascular complications.
- MRI safety depends on the specific system components and whether they remain in the patient. The device is generally removed after the procedure; users should check the current manufacturer labeling before MRI.
- Potential contraindications and precautions include unsuitable venous or pulmonary arterial anatomy, inability to obtain safe vascular access, significant bleeding risk, and conditions in which catheter manipulation or anticoagulation is unsafe.
Related Literature
The linked study discusses a novel case of cardiac tamponade following the use of the FlowTriever system for percutaneous pulmonary embolectomy. The study highlights the potential risks associated with large-bore catheter use in the pulmonary vasculature. While the FlowTriever system is effective in reducing clot burden, clinicians should be aware of and prepared to manage possible complications. The study is limited by its focus on a single case, emphasizing the need for further research to better understand the risk profile of the device.
Procedures that use this device
Linked Studies (14)
PubMed • 2026
Percutaneous Aspiration of a Large Mitral Valve Vegetation With Full-Body Protection: A Novel Approach.
JACC. Case reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Novel percutaneous aspiration thrombectomy in Fontan conduit obstruction with cardiogenic shock. Case report.
International journal of cardiology. Congenital heart disease
Case Report View Source →PubMed • 2025
Early Experience Using Venous Sheath With Embolic Protection During Thrombectomy of Inferior Vena Cava and Complex Iliofemoral Deep Vein Thrombosis.
The American surgeon
Case Series View Source →PubMed • 2024
Percutaneous pulmonary aspiration thrombectomy in an adolescent fontan patient using a large-bore system.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Other View Source →PubMed • 2024
[Interventional therapy of pulmonary embolism - update].
Deutsche medizinische Wochenschrift (1946)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2024
Procedure-Related Mortality in Aspiration Thrombectomy for Pulmonary Embolism: A MAUDE Database Analysis of the Inari FlowTriever and Penumbra Indigo Systems.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.
Circulation. Cardiovascular interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Mechanical thrombectomy of inferior vena cava filter-associated caval thrombosis using FlowTriever and ClotTriever systems.
Journal of vascular surgery. Venous and lymphatic disorders
Other View Source →PubMed • 2022
Percutaneous FlowTriever Retrieval/Aspiration System for Impending Paradoxical Embolism: A New Tool?
JACC. Cardiovascular interventions
View Source →PubMed • 2022
A Novel Case of Cardiac Tamponade after Percutaneous Pulmonary Embolectomy Using the FlowTriever Retrieval/Aspiration System.
European journal of case reports in internal medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study.
JACC. Cardiovascular interventions
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
Percutaneous Pulmonary Embolectomy Using the FlowTriever Retrieval/Aspiration System.
Journal of vascular and interventional radiology : JVIR
View Source →Frequently Asked Questions
What is the FlowTriever Retrieval Aspiration System used for?
It is used for mechanical thrombectomy in patients with pulmonary embolism to remove clots from the pulmonary arteries.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of pulmonary embolism in patients with significant clot burden, particularly those at intermediate to high risk.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.