FDA Medical Device Recalls (openFDA)
Medtronic Vascular, Inc.: Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Recall number
- Z-0290-2022
- Recalling firm
- Medtronic Vascular, Inc.
- Product
- Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Status
- Open, Classified
- Initiated
- 2021-10-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
- 510(k) numbers
- not on file
- PMA numbers
- ["P100021"]
- Product code
- MIH
- Firm FEI
- 3005364322
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28