Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: Recalled by Baylis Medical Corp * Due to The firm is voluntarily recalling lots of the...
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
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.
Quantity: 28,093 units
Why Was This Recalled?
The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.
Where Was This Sold?
Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
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