FDA-Device2022-06-22Class II
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Micro Therapeutics, Inc.
Hazard
Due to incorrect size and configuration labeling of the detachable coil system.
Sold states
International distribution in the countries of China and Republic of Korea.
Affected count
96 systems
Manufactured in
9775 Toledo Way, Irvine, CA, United States
Products
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2022Don't want to check this manually?
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