April 27, 2021

FDA: Class I recall of Cordis Precise PRO Rx US Carotid System

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious.

The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. 

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The System, which is used to treat patients with narrowed carotid arteries, includes a metal self-expanding stent preloaded on a delivery catheter.

There have been seven complaints, including five injuries. No deaths have been reported.

Distribution dates were December 6, 2019, to February 8, 2021.


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