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Micro Therapeutics, Inc. recalls AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Recalled June 22, 2022 · FDA recall Z-1261-2022 · Micro Therapeutics
Hazard
Due to incorrect size and configuration labeling of the detachable coil system. · FDA Class II
Units
96 systems
Sold at
International distribution in the countries of China and Republic of Korea.
Description
Due to incorrect size and configuration labeling of the detachable coil system.
Product
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Manufacturer(s)
Micro Therapeutics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →