The TorFlex Transseptal Guiding Sheath Kit manufactured by Baylis Medical was recalled because the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream. This recall covers 1,035 kits manufactured between December 22, 2011, and July 24, 2013.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The TorFlex Transseptal Guiding Sheath Kit is a single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The components of the device include a sheath, a dilator and a J-tipped guidewire.
See the FDA Recall Announcement
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues