Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons
Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.
- Product
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
- Category
- Medical Device
- Distribution
- 12 states