FDA Device recall Z-0290-2022
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE by Medtronic Vascular, citing during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0290-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-15 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
Product
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Reason
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Identifiers
| code_info | Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2022%22
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