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FDAnews Device Daily Bulletin

Cordis Recalls Precise Pro RX System

June 1, 2016

Cordis is voluntarily recalling 179 lots of its Precise Pro RX system following complaints involving shaft separation during stent deployment.

The recall affects products manufactured between April 27, 2015 and Nov. 22, 2015. Thus far, no injuries linked to the recall have been reported, according to the Cardinal Health subsidiary’s safety notice.   

The company warns that the inability to deploy the stent may result in intra-procedural delay, vessel damage or stroke.

The device is intended for use in patients with stenotic lesions of the carotid artery. — Anisa Jibrell

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