Medtronic Evolut R System Recalled for Potential Valve Leaflet Damage
Medtronic is recalling Evolut R System transcatheter aortic valves due to a potential risk of leaflet damage during post-implant balloon dilatation.
- Product
- Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT…
- Category
- Medical Device
- Distribution
- Distributed nationwide