Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Baylis Medical TorFlex Transseptal Guiding Sheath Recalled by Baylis Medical Corp * Due to The TorFlex Transseptal Guiding Sheath Kits are being...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baylis Medical Corp * directly.
Affected Products
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
Quantity: 370 devices
Why Was This Recalled?
The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baylis Medical Corp *
Baylis Medical Corp * has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report