📋 FDA Reference
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 systems. It is primarily used by interventional radiologists and vascular specialists to remove blood clots.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242104 ↗
Decision Date ?
February 13, 2025
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter RED 72 was cleared through the FDA 510(k) pathway on February 13, 2025. 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 procedures. It works by navigating through the venous system to reach and remove thrombi, or blood clots, using suction or other mechanical means. This device is part of a broader system aimed at restoring blood flow in patients with venous thromboembolism.
FDA-Cleared Indications
- Intended for the removal of thrombus from blood vessels.
- Used as part of a catheter-based system for mechanical thrombectomy.
- Use is limited to the indications, anatomy, and conditions described in the FDA-cleared labeling and instructions for use.
Clinical Applications
- Catheter-based removal of thrombus from the venous circulation when the treating physician determines mechanical thrombectomy is appropriate.
- Mechanical thrombectomy procedures for selected patients with acute venous thromboembolism, including deep vein thrombosis.
- Mechanical thrombectomy procedures for selected patients with pulmonary embolism when the device and system labeling cover the intended anatomy and procedure.
- Removal of clot from selected thrombosed dialysis grafts or fistulas when the device is used within its cleared labeling and system instructions.
Practical Considerations
- The RED 72 is used with compatible access devices, guidewires, aspiration tubing, and other components specified by the manufacturer.
- The catheter is selected and advanced according to vessel diameter, clot location, clot burden, access anatomy, and the device's instructions for use.
- Procedures generally require fluoroscopic or other appropriate image guidance and are performed by physicians trained in endovascular thrombectomy.
- Review the current labeling for contraindications, warnings, vessel-size limitations, compatibility, and MRI conditions before use; MRI safety depends on the complete device system and any retained components.
- Potential complications include bleeding, vascular injury, perforation, embolization, infection, contrast reaction, arrhythmia, and complications related to anesthesia or vascular access.
Related Literature
The linked study compared systemic thrombolysis with catheter-directed management for acute intermediate-high risk pulmonary embolism. Although specific details are not available, such studies typically evaluate the efficacy and safety of catheter-based interventions versus systemic drug therapy. Limitations may include sample size and the lack of long-term outcome data.
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 in the venous system to remove blood clots.
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 the removal of thrombi in patients with venous thromboembolism, such as pulmonary embolism and 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.