📋 FDA Reference
Penumbra System Reperfusion Catheter Red 43
Product: Red 43 — all models and sizes · Where to buy
Summary: The Penumbra System Reperfusion Catheter RED 43 is a medical device used for mechanical thrombectomy in venous systems, primarily by interventional radiologists and vascular specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222808 ↗
Decision Date ?
December 20, 2022
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter RED 43 was cleared via the FDA 510k pathway on December 20, 2022. It is manufactured by Penumbra and is classified as a Class 2 device.
What It Is
The Penumbra System Reperfusion Catheter RED 43 is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to remove thrombi or blood clots from veins. The device is part of a larger system that includes aspiration and retrieval components, facilitating efficient clot removal.
FDA-Cleared Indications
- Intended for the removal of thrombus from the peripheral vasculature.
- Used with compatible Penumbra System components for aspiration thrombectomy.
- The product code identifies it as a thrombus-retrieval catheter for endovascular clot removal.
Clinical Applications
- Mechanical thrombectomy for selected acute pulmonary embolism cases.
- Mechanical thrombectomy for selected lower-extremity deep vein thrombosis.
- Thrombectomy for selected thrombosed dialysis grafts or fistulas when the catheter and complete system are used according to labeling.
- Aspiration-based removal of peripheral venous thrombus in a hospital endovascular procedure.
Reported off-label uses
- Use in selected arterial thrombectomy procedures may be reported in clinical practice, but this is not necessarily covered by the device's specific FDA labeling.
- Use in other peripheral vascular beds or thrombus types outside the labeled indication should be considered off-label and requires clinician judgment.
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 catheter must be used with compatible guidewires, introducer sheaths, aspiration tubing, and a vacuum or aspiration source specified by the manufacturer.
- Catheter size and access equipment must be selected according to the target vessel, clot burden, anatomy, and the manufacturer's instructions for use.
- The procedure is performed under fluoroscopic imaging, commonly through femoral or other suitable venous access, with local anesthesia and moderate sedation or general anesthesia depending on the patient and procedure.
- MRI safety depends on the catheter's material and whether it remains in the patient; the exact device labeling should be checked before MRI. A catheter intended for single procedural use is not designed for long-term implantation.
- Potential complications include bleeding or hematoma at the access site, vessel injury, perforation, embolization, contrast reaction, infection, recurrent thrombosis, and complications related to sedation or anticoagulation.
Related Literature
The linked study compares systemic thrombolysis with catheter-directed management for acute intermediate-high risk pulmonary embolism. While the abstract is not available, such studies typically evaluate the efficacy and safety of catheter-based interventions versus traditional 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 43 used for?
It is used for mechanical thrombectomy to remove blood clots from venous systems, such as in pulmonary embolism or deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in venous thromboembolic conditions, such as 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.