Device evidence

device-recall:cfres:197593

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

Official recall number

Z-1048-2023

Evidence summary

Product code: MLV
Recall status: Open, Classified
Event initiated: December 14, 2022
Root cause: Employee error
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1048-2023