Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NRG RF Transseptal Kit 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
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
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 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