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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:187953

CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;

Official recall number

Z-2042-2021

Evidence summary

Product code
NPT
Recall status
Open, Classified
Event initiated
June 11, 2021
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2042-2021