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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:209553

Impella 5.5 Set AU; Product Code: 1000361;

Official recall number

Z-2968-2024

Evidence summary

Product code
OZD
Recall status
Open, Classified
Event initiated
August 05, 2024
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2968-2024