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

Recall Z-1976-2021 — Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

U.S. FDA — Device Enforcement · United States · 2021-04-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1976-2021
Date of alert
2021-04-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Vascular, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00613994990983
Reported risk: Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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