Cordis Corporation recalls Cordis S.M.A.R.T. Flex Vascular Stent System
- Recall date
- February 16, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1826-2017
- FDA classification
- Class II
- Brand / firm
- Cordis Corporation
- Sold / distributed
- FOREIGN ONLY: ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, IRAN, ISRAEL, ITALY, JORDAN, KOREA (South), KUWAIT, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, POLAND, PORTUGAL, SAUDI ARABIA, SERBIA, SINGAPO…
Why it was recalled
Deployment Difficulty.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cordis S.M.A.R.T. Flex Vascular Stent System
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