FDA Class I Recall for Some Cordis Carotid Stent Systems

Megan Brooks

Disclosures

April 23, 2021

Cordis Corporation, part of Cardinal Health, has recalled certain lots of its Precise PRO Rx carotid stent system due to a risk of separation of the distal tip of the sheathed delivery system during use.

The US Food and Drug Administration (FDA) has classified this recall as class I, the most serious type, because of the potential for serious injury or death.

"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," notes the recall notice posted on the FDA website.

To date, there have been seven complaints, including five reported injuries, related to this device issue. No deaths have been reported.

The Precise PRO Rx stent system is used in patients with stenotic lesions of the carotid arteries. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent.

The recall covers 7300 devices made between October 2019 and August 2020 and distributed between December 6, 2019, to February 8, 2021.

The FDA has a complete list of product and lot numbers for the recalled devices on their website.

The company sent an urgent medical device recall letter to all affected customers asking them to check inventories and providing instructions on how to return any recalled product they have on hand.

Healthcare providers with questions about this recall can contact the company by email at GMB-FieldCorrectiveActionp@cardinalhealth.com or by phone at 786-313-2087.

Healthcare providers can report adverse reactions or quality problems they experience using these devices to the FDA's MedWatch program.

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