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Terminated

Cordis S.M.A.R.T. Flex Vascular Stent System

FDA Recall Z-1826-2017 · Posted None

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeMAF
Date Initiated2017-02-16
Date Terminated2019-08-06
Product Quantity2,700

Reason for Recall

Deployment Difficulty.

Firm 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.)

Root Cause

Other

Distribution Pattern

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, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED KINGDOM

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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