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Gunther Tulip R Vena Cava Filter Retrieval Set
Summary: The Gunther Tulip R Vena Cava Filter Retrieval Set is used to retrieve IVC filters. It's typically utilized by interventional radiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181757 ↗
Decision Date ?
November 6, 2018
Product Code ?
MMX
Device Class ?
Class 2
Evidence ?
10 studies
The Gunther Tulip R Vena Cava Filter Retrieval Set was cleared through the FDA 510k pathway on November 6, 2018. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Gunther Tulip R Vena Cava Filter Retrieval Set is a medical device designed for the retrieval of inferior vena cava (IVC) filters. These filters are used to prevent pulmonary embolism by capturing blood clots. The retrieval set allows for the safe and effective removal of these filters once they are no longer needed, minimizing potential complications associated with long-term filter placement.
FDA-Cleared Indications
- Retrieval of compatible Gunther Tulip and other indicated IVC filters according to the device labeling.
- Percutaneous removal of an IVC filter through an endovascular approach.
Clinical Applications
- Image-guided percutaneous retrieval of a compatible IVC filter.
- Removal of an IVC filter after the patient's risk of pulmonary embolism has changed and the filter is no longer indicated, when retrieval is appropriate.
- Retrieval performed by an appropriately trained clinician in a hospital or interventional radiology setting.
Practical Considerations
- Compatibility must be confirmed before use; the retrieval set is intended for specified IVC filter designs and configurations.
- Retrieval is typically performed through venous access, commonly the internal jugular vein, under fluoroscopic guidance.
- Filter tilt, endothelial incorporation, fracture, migration, thrombus, or prolonged dwell time can make retrieval more difficult or unsuccessful.
- The device should be used by clinicians trained in IVC filter retrieval, with access to imaging, venous intervention, and management of potential complications.
- MRI safety depends on the retained IVC filter and its labeling; the retrieval set is not left in the body after the procedure and should not be considered an implanted MRI device.
Procedures that use this device
Linked Studies (10)
PubMed • 2022
Case report: Endoluminal removal of a retrievable conical inferior vena cava filter with a ruptured retraction hook attached to the wall.
Frontiers in surgery
Case Report View Source →PubMed • 2016
Factors affecting Cook Gunther Tulip and Cook Celect inferior vena cava filter retrieval success.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2014
Safety and efficacy of the Gunther Tulip retrievable vena cava filter: midterm outcomes.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Successful removal of a Gunther tulip vena cava filter with wall-embedded hook and migration during a retrieval attempt.
Acta radiologica short reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Retrieval of gunther tulip vena cava filter with thrombosed hook and a leg incorporated into the vena cava wall.
Annals of vascular diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
Endovascular repair of a perforation of the vena caval wall caused by the retrieval of a Gunther Tulip filter after long-term implantation.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2008
Form and function of vena cava filters: how do optional filters measure up?
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2007
Evaluation of retrievability of the Gunther tulip vena cava filter.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2005
New optional IVC filter for percutaneous retrieval--in vitro evaluation of embolus capturing efficiency.
RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
View Source →Frequently Asked Questions
What is the Gunther Tulip R Vena Cava Filter Retrieval Set used for?
It is used for the retrieval of inferior vena cava (IVC) filters that are no longer needed by the patient.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the retrieval of IVC filters in patients who no longer require them.
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.