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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:192641

Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q

Official recall number

Z-0990-2022

Evidence summary

Product code
LWS
Recall status
Open, Classified
Event initiated
March 10, 2022
Root cause
Component design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0990-2022