Recall Z-1826-2017 ยท MAF Stent, Coronary
Cordis Corporation
Cordis S.M.A.R.T. Flex Vascular Stent System
| Date | Feb 16, 2017 |
| Status | Terminated |
| Reason | Deployment Difficulty. |
| Root cause | Other |
| Action | Email to the Cardinal Health and J&J country entities sent February 16, 2017. Each country will perform the recall locally. (This is an OUS only Removal.) |
| Quantity | 2,700 |
| Distribution | 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, SINGAPOR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.