Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0290-2022 — Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

U.S. FDA — Device Enforcement · United States · 2021-10-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0290-2022
Date of alert
2021-10-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Vascular, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000006129
Reported risk: During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.