Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Evolut (TM) PRO+ System. With the following model numbers: a. Recalled by Medtronic Heart Valves Division Due to Potential for Transcatheter Aortic Valve (TAV) leaflet damage...
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
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
Quantity: 19,961 units
Why Was This Recalled?
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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