Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TorFlex Transseptal Guiding Sheath Recalled by Baylis Medical Company Inc. Due to There is a remote potential for the sterile...
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 Company Inc. directly.
Affected Products
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.
Quantity: Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
Why Was This Recalled?
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
Where Was This Sold?
Product distributed throughout the 50 states and in Washington D.C.
About Baylis Medical Company Inc.
Baylis Medical Company Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report