Medtronic Vascular, Inc. Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

Recommended Action

Per FDA guidance

On or about 10/15/2021, the firm initiated a global verbal notification to customers informing them that is the potential for a specific subset of 18Fr Stent Graft Systems to have the potential for the spindle to detach from the spindle hypotube during deployment. On 10/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery. Customers are instructed to take the following actions: 1) Return all unused affected devices to the Recalling Firm 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 Recall notice to all those who need to be aware within their organization to include physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, forward this notice to those entities. For questions or assistance - contact their Field Representative or Customer Service at 888-283-7868 or email rs.recalls@medtronic.com.