FDA announces recall of carotid stent system after 5 reported injuries

The FDA has announced that Cordis Corporation is recalling its Precise PRO Rx US Carotid System, used for the treatment of carotid artery disease, due to the potential separation of the atraumatic distal tip of the sheathed delivery system.

This is a Class I recall, meaning the use of this device “may cause serious injuries 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,” according to the FDA. “There have been seven complaints, including five reported injuries about this device issue.”

No deaths have been reported at this time.

Cordis Corporation first initiated the recall on Feb. 11, the FDA reported. Devices impacted by this issue were manufactured from October 2019 to August 2020 and distributed from December 2019 to February 2021.

Any physicians who find that they have affected devices have been instructed to set them aside to ensure they are not used. More information is available here.