Recall of Lotus Edge Valve System Transcatheter Aortic Valve Prosthesis Due to Deployment Locking Failure
Boston Scientific recalls 278 Lotus Edge Valve Systems due to a failure in visual inspection that prevents proper valve locking during deployment, potentially preventing delivery system release.
- Product
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Category
- Medical Device
- Distribution
- 38 states