The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall.
Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients.
The Precise Pro Rx is used to treat patients with narrowed carotid arteries and includes a metal (nitinol) self-expanding stent that is preloaded on a delivery catheter used to place the stent.
According to an FDA release, if the device separates during use, it may cause serious adverse events, such as the removal of the separated tip from the carotid artery, embolization distally or stroke.
To date, there have been seven complaints about the issue with the Precise Pro Rx carotid stent system. Five injuries were reported, although no deaths have been registered as a result of the issue to date.
Affected products were manufactured between October 2019 and August 2020 and distributed between Dec. 6, 2019, and Feb. 8, 2021. Cordis has recalled 7,300 affected devices in the U.S. since initiating the recall on Feb. 11, 2021.