Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is Recalled by Elana, Inc. Due to Distribution of an unapproved device into interstate commerce.
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 Elana, Inc. directly.
Affected Products
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Quantity: 3 devices
Why Was This Recalled?
Distribution of an unapproved device into interstate commerce.
Where Was This Sold?
Distributed in the states of Pennsylvania, Texas, and New York.
About Elana, Inc.
Elana, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report