đź“‹ FDA Reference
flowtriever retrieval aspiration system
Inari Medical
Summary: The FlowTriever Retrieval Aspiration System is a device used for mechanical thrombectomy in patients with pulmonary embolism. It is typically used by interventional radiologists or cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K183198 ↗
Decision Date
December 17, 2018
Product Code
QEW
Device Class
Class 2
Evidence
14 studies
The FlowTriever Retrieval Aspiration System by Inari Medical was cleared via the FDA 510(k) pathway on December 17, 2018. It is a Class 2 medical device.
What It Is
The FlowTriever Retrieval Aspiration System is a mechanical thrombectomy device designed to remove blood clots from the pulmonary arteries. It uses a large-bore catheter to aspirate clots, providing a minimally invasive option for treating pulmonary embolism. This device allows for rapid clot removal without the need for thrombolytic drugs, reducing the risk of bleeding complications.
Clinical Applications
The device is commonly used in the treatment of intermediate- to high-risk pulmonary embolism, where rapid clot removal is crucial. It is typically employed in hospital settings, particularly in interventional radiology or cardiology departments. The system is suitable for patients who are at risk of complications from thrombolytic therapy or when immediate clot removal is necessary.
Indications for Use
The FDA has cleared the FlowTriever System for use in patients with pulmonary embolism, specifically those who have a significant clot burden that requires mechanical intervention. It is intended for patients who are at intermediate to high risk and need rapid intervention.
Practical Considerations
The FlowTriever System is available in various sizes to accommodate different patient anatomies. It is compatible with standard catheterization lab equipment. Clinicians should be trained in large-bore catheter techniques and be aware of potential complications such as vascular injury.
Related Literature
The linked study discusses a case of cardiac tamponade following the use of the FlowTriever System for percutaneous pulmonary embolectomy. While the device is effective in reducing clot burden, this case highlights the potential for serious complications. The study suggests careful patient selection and monitoring during the procedure. Limitations include its focus on a single case, which may not represent typical outcomes.
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 mechanically removing blood clots from the pulmonary arteries in patients with pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is cleared for use in patients with pulmonary embolism who have a significant clot burden and are 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.