A carotid system used to place stents in patients’ arteries is being recalled due to defective tips, which may separate and get lodged in a patient’s body, creating a risk of stroke and other health problems.
The FDA announced a Precise Pro Rx US Carotid System recall on April 23, following at least seven complaints of problems with the atraumatic distal tip, which separated during use and resulted in multiple patient injuries.
The Cordis Corporation PRO Rx US Carotid System is used to place stents in patients suffering from narrowed carotid arteries. The system uses a metal self-expanding stent which is inserted with a catheter into the narrowed artery.
The officials have become aware of multiple incidents in which the distal tip became separated from the lumen wire of the delivery system. The FDA statement warns that tip separation could cause serious adverse events, including the need for surgical intervention to remove the separated tip from the carotid artery, embolism, or stroke.
To date, a total of seven adverse reports have been received, with five of the incidents resulting in serious patient injury.
On February 11, Cordis Corporation issued an Urgent Medical Device Recall letter to all affected customers, urging them to immediately stop using the devices, quarantine any remaining inventory, and to follow the instructions on how to return the devices to the manufacturer.
The recall affects the Precise PRO Rx Carotid Stent implant system, with product codes PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, and PC1040RXC.
The devices were manufactured by Cordis Corporation of Miami Lakes, Florida, from October 2019 through August 2020 and were distributed to customers from December 6, 2019 to February 8, 2021. Cordis indicates approximately 18,218 units were distributed to customers throughout the United States and Taiwan. Of those, about 7,300 were sold in the U.S. according to the FDA.
Following the reported injuries, the FDA classified the recall as a Class I recall, indicating it is the most serious of its kind, indicating the use of the devices have a high probability of causing serious patient injury or death.
Customers with questions or concerns regarding the recall are being asked to contact their local sales representative or Cordis QA by emailing GMB-FieldCorrectiveActionp@cardinalhealth.com or calling (786) 313-2087. Health care professionals and consumers are being instructed to report adverse reactions or quality problems to the FDA Safety Information and Adverse Event Reporting Program.