Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic EnVeo R Delivery Catheter System (DCS) Recalled by Medtronic Cardiovascular Surgery-the Heart Valve Division Due to Potential for vascular trauma with the use of...
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
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
Quantity: 7,319 units
Why Was This Recalled?
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Where Was This Sold?
Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
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