Device evidence

device-recall:cfres:189354

REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

Official recall number

Z-0169-2022

Evidence summary

Product code: MLV
Recall status: Open, Classified
Event initiated: September 02, 2021
Root cause: Software change control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0169-2022