FDA: Class I Recall of Precise PRO Rx Carotid Stent System

Today the US Food and Drug Administration alerted physicians to news that Cordis Corporation has recalled their Precise PRO Rx carotid stent system in the United States due to the potential for separation of the atraumatic distal tip of the sheathed delivery system.

“If the device separates during use this may cause serious adverse events such as removal of the separated tip from the carotid artery, embolization distally, or stroke,” the FDA’s medical device recall summary stated.

There have been seven complaints related to this issue, including five reported injuries, but no reported deaths. The agency has deemed the action Class I, its most serious category.

Cordis sent out an urgent medical device recall letter to clinicians on February 11, 2021, instructing them to thoroughly check their inventory and set aside any affected units, so that they can be sent back to the company. Additionally, if facilities have sent any other facility affected units, they should contact them about the issue.

The recall covers 7,300 Precise PRO Rx systems across the US that were manufactured in the period spanning October 2019 to August 2020 and distributed from December 6, 2019, until February 8, 2021. A full list of affected devices can be found here.