The FDA put a Class I label on Baylis Medical’s recall of its TorFlex transseptal guiding sheath kit, the federal watchdog agency announced.
The recall was issued because the sheath could remove particulate of less than 5mm from the dilator and the particulate could end up in the bloodstream, the FDA said.
The TorFlex Transseptal Guiding Sheath Kit, comprised of a sheath, a dilator and a J-tipped guidewire, is designed for catheterization and angiography of specific heart chambers. The FDA noted that the recall affects products from lots TFFA070213 to TFFA070235.
Baylis sent a letter to customers, instructing them to examine their inventory and quarantine affected TorFlex transseptal guiding sheath lots. Customers were asked to sign and return a Medical Device Correction Acknowledgment Form directly to Baylis.