Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons
Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.
- Product
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
- Category
- Medical Device
- Distribution
- 12 states