Class 2 Device Recall Endurant II/IIs Stent Graft System

• Date Initiated by Firm: June 07, 2021
• Create Date: July 23, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2135-2021
• Recall Event ID: 88158
• PMA Number: P100021
• Product Classification: System, endovascular graft, aortic aneurysm treatment - Product Code MIH
• Product: Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
• Code Information: Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882
• Recalling Firm/ Manufacturer: Medtronic Vascular, Inc.; 3850 Brickway Blvd; Santa Rosa CA 95403-8223
• Manufacturer Reason for Recall: During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
• FDA Determined Cause: Under Investigation by firm
• Action: On 06/07/2021, the firm initiated a verbal notification regarding an "URGENT MEDICAL DEVICE RECALL" which informed customers that Earlier this week, Medtronic identified the potential for a specific subset of 20Fr Endurant II/IIs Stent Graft Systems to have the potential for the Radiopaque Marker to detach during deployment. There is evidence that devices that used one batch of graft cover subassemblies has a higher potential to exhibit this failure mode. This is an acute failure of the delivery system, there are no concerns with previously implanted stent grafts. We are requesting that you immediately refrain from using this specific subset of products and place it in quarantine until further notice. You will be receiving an official recall notice with instructions for product return for credit or replacement. Your Sales Representative will assist you with this process. We apologize for the inconvenience; however, this action is necessary to ensure the utmost patient safety with the use of our products. On 06/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-Day delivery that restated the verbal notification. The Customer Notification Letter instructed customers to: 1)Return all unused affected devices via their sales representative or calling customer service at 1-888-283-7868 or email rs.aorticorders@medtronic.com. 2)Complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. 3)Forward this notice to all those who need to be aware within their organization. For questions or assistance, contact Customer Service at 1-888-283-7868.
• Quantity in Commerce: 18 devices
• Distribution: U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MIH