📋 FDA Reference
Penumbra System Red 68 Reperfusion Catheter
Product: Red 68 — all models and sizes · Where to buy
Summary: The Penumbra System RED 68 Reperfusion Catheter is a medical device used for mechanical thrombectomy in venous systems. It is typically used by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211411 ↗
Decision Date ?
July 1, 2021
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System RED 68 Reperfusion Catheter was cleared through the FDA 510(k) pathway on July 1, 2021. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System RED 68 Reperfusion Catheter is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to reach and remove blood clots, particularly in venous circulation. The catheter's design allows for effective clot retrieval, helping to restore blood flow and reduce the risk of complications associated with thrombosis.
FDA-Cleared Indications
- Used to remove thrombus or emboli from the peripheral vascular system.
- Intended for use in the peripheral vasculature, including venous vessels, during mechanical thrombectomy procedures.
Clinical Applications
- Endovascular removal of thrombus from peripheral veins in selected patients with venous thromboembolism.
- Catheter-based treatment of acute peripheral venous occlusion when mechanical clot removal is clinically indicated.
- Use with compatible guidewires, access sheaths and aspiration equipment during an image-guided thrombectomy procedure.
Reported off-label uses
- Use in pulmonary embolism thrombectomy may be considered off-label unless specifically covered by the device's current labeling and procedural setup.
- Use in dialysis access thrombectomy may be off-label depending on the treated anatomy, indication and current labeling.
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 RED 68 is a large-bore reperfusion catheter; the treating clinician must select a compatible introducer sheath, guidewire and aspiration system based on the catheter instructions for use.
- Access is generally obtained through a peripheral vein or another appropriate vascular route under fluoroscopic or other image guidance.
- The catheter is advanced carefully to avoid vessel injury, dissection, perforation or loss of clot fragments. Vessel diameter, clot burden, tortuosity and access-site anatomy affect device selection.
- Review the current manufacturer instructions for use for contraindications, warnings, compatibility, preparation, aspiration technique and MRI status. MRI conditions should not be assumed from the catheter name alone.
- Potential complications include bleeding or hematoma at the access site, vascular injury, distal embolization, infection, contrast-related reactions and complications related to sedation or anticoagulation.
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 RED 68 Reperfusion Catheter used for?
It is used for mechanical thrombectomy to remove blood clots from the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in the venous system, particularly for conditions like deep vein thrombosis.
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.