Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EnVeo R Loading System Recalled by Medtronic Cardiovascular Surgery-the Heart Valve Division Due to Medtronic is recalling the EnVeo R Loading Systems...
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 Medtronic Cardiovascular Surgery-the Heart Valve Division directly.
Affected Products
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Quantity: 6,912 units total (540 units in US)
Why Was This Recalled?
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Cardiovascular Surgery-the Heart Valve Division
Medtronic Cardiovascular Surgery-the Heart Valve Division 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