FDA recall Z-2546-2020

Cook Inc. · Class II · device

Product

Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.

Reason for recall

Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.

Distribution

Foreign distribution to the countries of Canada, Chile, Argentina, Colombia, Great Britain, AUSTRIA Belgium. CZECH REPUBLIC DENMARK ESPA¿A France GERMANY GREECE HUNGARY ICELAND IRELAND ISRAEL Italia MARTINIQUE Nederland NORWAY POLAND PORTUGAL SERBIA SOUTH AFRICA SWEDEN UNITED KINGDOM Australia Hong Kong Thailand

Key facts

Status
Terminated
Initiation date
2020-06-02
Report date
2020-07-15
Termination date
2022-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2546-2020