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Medtronic Vascular, Inc. recalls Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF
Recalled March 29, 2017 · FDA recall Z-1543-2017 · Medtronic Vascular
Hazard
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure. · FDA Class II
Units
3331 devices
Sold at
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Argentina Armenia Australia Austria Belgium Brazil Bulgaria Canada China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Finland France French Polynesia Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Mexico Montenegro Netherlands New Zealand Norway Oman Panama Paraguay Peru Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam
Description
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
Product
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
Manufacturer(s)
Medtronic Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →