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U.S. Department of Health and Human Services

Class 2 Device Recall Endurant Stent Graft System

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  Class 2 Device Recall Endurant Stent Graft System see related information
Date Initiated by Firm October 15, 2021
Create Date November 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-0290-2022
Recall Event ID 88951
PMA Number P100021 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product Endurant Stent Graft System
REF/Description:
ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Code Information Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Recalling Firm/
Manufacturer		 Medtronic Vascular, Inc.
3850 Brickway Blvd
Santa Rosa CA 95403-8223
For Additional Information Contact Medtronic Customer Service
888-283-7868
Manufacturer Reason
for Recall		 During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 2 devices
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, 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 and Original Applicant = Medtronic Vascular
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