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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:177019

lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

Official recall number

Z-0345-2020

Evidence summary

Product code
OZD
Recall status
Terminated
Event initiated
September 04, 2019
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0345-2020