Teleflex and its subsidiary Arrow International recalled 334,995 catheter kits after receiving reports of increased resistance in the guidewire handle and chamber during use, the FDA said April 3.
The recall applies to ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. The FDA said the kits could cause injury to blood vessel walls, narrowing of the blood vessels, artery blockage or death. To date, the agency has received reports of 10 injuries and one death related to the issue.
Teleflex and Arrow first notified customers of the recall in February, urging them to immediately quarantine and return all affected products.