November 11, 2013 — The U.S. Food and Drug Administration (FDA) announced a Class I recall of Baylis Medical’s TorFlex Transseptal Guiding Sheath Kit device designed for catheterization specific heart chambers. The FDA said the sheath could remove particulate of less than 5 mm from the dilator, which can embolize into a patient’s bloodstream. The recall covers 1,035 kits manufactured between Dec. 22, 2011 and July 24, 2013.
The recall was initiated Sept. 23, 2013. Baylis Medical sent an urgent device recall letter to their customers, who were instructed to examine their inventory and quarantine affected TorFlex Transseptal Guiding Sheath lots. Customers were then asked to sign and return a Medical Device Correction Acknowledgment Form directly to Baylis via fax.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
For more information: www.baylismedical.com, www.fda.gov