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

Recall Z-1039-2017 — AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoi

U.S. FDA — Device Enforcement · United States · 2016-12-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1039-2017
Date of alert
2016-12-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Endologix
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1298056012
Reported risk: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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