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. EVOLUTPRO-23 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. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-23 PRO COMM 29L OUS SA, VLV EVOLUTPRO-23 PRO COMM 29L AUS; b. EVOLUTPRO-23-US, Labeled as: VLV EVOLUTPRO-23-US BLUE COMM US, VLV EVOLUTPRO-23-US PRO BLNK US; c. EVOLUTPRO-26, Labeled as: VLV EVOLUTPRO-26 PRO COMM 29L OUS, VLV EVOLUTPRO-26 BLUE 6L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L AUS, VLV EVOLUTPRO-26 BLUE COMM JPN, VLV EVOLUTPRO-26 BLUE 29L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L CAN, VLV EVOLUTPRO-26 PRO COMM 29L OUS SA; d. EVOLUTPRO-26-US, Labeled as: VLV EVOLUTPRO-26-US BLUE COMM US, VLV EVOLUTPRO-26-US PRO BLNK US; e. EVOLUTPRO-29, Labeled as: VLV EVOLUTPRO-29 PRO COMM 29L OUS, VLV EVOLUTPRO-29 BLUE 29L COMM OUS, VLV EVOLUTPRO-29 BLUE 6L COMM OUS, VLV EVOLUTPRO-29 PRO COMM 29L AUS, VLV EVOLUTPRO-29 BLUE COMM JPN, VLV EVOLUTPRO-29 PRO COMM 29L CAN, VLV EVOLUTPRO-29 PRO COMM 29L OUS SA; f. EVOLUTPRO-29-US, Labeled as: VLV EVOLUTPRO-29-US BLUE COMM US, VLV EVOLUTPRO-29-US PRO BLNK US g. , Labeled as:
Quantity: 71,030 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