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Penumbra System Reperfusion Catheter Red 72
Product: Red 72 — all models and sizes · Where to buy
Summary: The Penumbra System Reperfusion Catheter RED 72 is a medical device used for mechanical thrombectomy in venous applications. It is primarily used by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211654 ↗
Decision Date ?
August 16, 2021
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter RED 72 was cleared via the FDA 510k pathway on August 16, 2021. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Reperfusion Catheter RED 72 is a specialized catheter designed for mechanical thrombectomy, a procedure to remove blood clots from veins. It operates by navigating through the vascular system to the site of the clot and using suction to extract the thrombus. This device is crucial in restoring blood flow in cases of venous thrombosis, reducing the risk of complications such as pulmonary embolism.
FDA-Cleared Indications
- Intended for the removal of thrombus from the vasculature using mechanical thrombectomy.
- Cleared for use in the peripheral vascular system; the FDA product classification identifies it as a catheter for thrombus retrieval.
Clinical Applications
- Endovascular aspiration thrombectomy for selected venous thromboembolism cases.
- Removal of thrombus from large peripheral veins when restoring venous blood flow is clinically indicated.
- Catheter-based treatment of selected acute deep vein thrombosis under imaging guidance.
- Catheter-based treatment of selected pulmonary embolism when the treating team determines that mechanical thrombectomy is appropriate.
Practical Considerations
- The RED 72 is a large-bore aspiration catheter; the required introducer sheath, guidewire, and accessory devices must be selected to match the catheter specifications.
- The procedure is performed with fluoroscopic or other appropriate imaging guidance through vascular access, commonly from the femoral or jugular vein depending on the target vessel.
- Operators should assess vessel size, clot location, access anatomy, bleeding risk, and the need for anticoagulation or other adjunctive treatment before use.
- MRI safety and conditions depend on the complete device system and the current manufacturer labeling. Confirm MRI compatibility before scanning; do not assume the catheter is safe while it remains in the body.
- Potential complications include bleeding or hematoma at the access site, vessel injury, perforation, embolization, contrast-related reactions, infection, arrhythmia, and incomplete thrombus removal.
Related Literature
The linked study compared systemic thrombolysis with catheter-directed management for acute intermediate-high risk pulmonary embolism. Although the abstract is not available, such studies typically evaluate the efficacy and safety of catheter-based interventions versus systemic drug therapy. Key findings likely include differences in patient outcomes, procedural success rates, and complication rates. Limitations may involve sample size and study design.
Procedures that use this device
Linked Studies (15)
PubMed • 2026
First-Pass Effect With Aspiration Thrombectomy With the Penumbra System in Patients With Acute Ischemic Stroke: A Core Laboratory-Adjudicated Subset Analysis of the COMPLETE Registry.
Stroke (Hoboken, N.J.)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.
Frontiers in neurology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results.
Stroke
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Efficacy of a coaxial system with a compliant balloon catheter for navigation of the Penumbra reperfusion catheter in tortuous arteries: technique and case experience.
Journal of neurosurgery
View Source →PubMed • 2018
Unilateral Acute Renal Artery Embolism: An Index Case of Successful Mechanical Aspiration Thrombectomy With Use of Penumbra Indigo Aspiration System and a Review of the Literature.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Efficiency of the Penumbra 5MAX ACE Reperfusion Catheter in Acute Ischemic Stroke Patients.
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Mechanical thrombectomy with the penumbra 3D separator and lesional aspiration: technical feasibility and clinical outcome.
Clinical neuroradiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Cerebral Venous Sinus Thrombosis: Successful Treatment of Two Patients Using the Penumbra System and Review of Endovascular Approaches.
The neuroradiology journal
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2012
Rescue forced-suction thrombectomy using the reperfusion catheter of the Penumbra System for thromboembolism during coil embolization of ruptured cerebral aneurysms.
Neurosurgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2012
The Penumbra system for mechanical thrombectomy in endovascular acute ischemic stroke therapy.
Neurology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
Direct thrombus retrieval using the reperfusion catheter of the penumbra system: forced-suction thrombectomy in acute ischemic stroke.
AJNR. American journal of neuroradiology
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
View Source →ClinicalTrials.gov
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
View Source →ClinicalTrials.gov
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
View Source →Frequently Asked Questions
What is the Penumbra System Reperfusion Catheter RED 72 used for?
It is used for mechanical thrombectomy to remove blood clots from veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for mechanical thrombectomy in cases of venous thromboembolism, such as deep vein thrombosis and pulmonary embolism.
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.