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Medtronic Cardiovascular Surgery-the Heart Valve Division recalls Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace th
Recalled August 24, 2016 · FDA recall Z-2546-2016 · Medtronic Cardiovascular Surgery-the Heart Valve Division
Hazard
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). · FDA Class II
Units
7,319 units
Sold at
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.
Description
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Product
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.
Manufacturer(s)
Medtronic Cardiovascular Surgery-the Heart Valve Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →