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.

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.

Medtronic sent an Urgent Medical Device Recall letter dated March 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received a potentially affected Endurant /Endurant II 23mm and / or 25mm Bifurcated Stent Graft System from the identified subset. As a result, Medtronic is asking that you take the following actions: Identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers that are in your inventory . Return unused products from the attached model and serial number list that are in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 (#4) and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of this product as necessary. Complete the attached Customer Confirmation Certificate and email it to [email protected] or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For further questions please call Customer Service at 1 (800) 633-8766.