Devices

Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System

Model / Serial
10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution --- including USA and countries of Japan and Canada.
Product Description
CORDIS S.M.A.R.T.¿ Control" Nitinol Stent System || Model Number(s): C10040SL, Manufactured in Mexico. || Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.
Manufacturer
Cordis Corporation
1 Event
- Recall of Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System

Manufacturer

Cordis Corporation

Manufacturer Address
Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes FL 33014
Manufacturer Parent Company (2017)
Cardinal Health
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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