The FDA has issued a Class 1 recall of the TorFlex Transseptal Guiding Sheath Kit, a device used in cardiac catheterization procedures.
Baylis Medical Company sent a letter to customers on Sept. 23 that announced an urgent device recall of 1,035 kits manufactured between Dec. 22, 2011, and July 4, 2013. The device includes a sheath, a dilator and a J-tipped guidewire. The sheath could remove particulate of less than 5 mm from the dilator, according to the FDA, and the particulate could potentially migrate into a patient’s bloodstream.
Physicians and hospitals should quarantine the devices and report any adverse events related to the product.
The affected lot numbers are available here.