Device evidence

device-recall:cfres:174653

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246

Official recall number

Z-2225-2019

Evidence summary

Product code: NPT
Recall status: Terminated
Event initiated: July 09, 2019
Root cause: Other
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2225-2019