Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoreValve Evolut R Delivery Catheter System Recalled by Medtronic Heart Valves Division Due to Due to reports of actuator separation for various...
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 Heart Valves Division directly.
Affected Products
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Quantity: Total of all Delivery Systems (Globally) = 67,339 units
Why Was This Recalled?
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Where Was This Sold?
This product was distributed to 47 states: AL, AK, AZ, AR, CA, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Medtronic Heart Valves Division
Medtronic Heart Valves Division has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report