FDA recall Z-1261-2022

Micro Therapeutics, Inc. · Class II · device

Product

AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

Reason for recall

Due to incorrect size and configuration labeling of the detachable coil system.

Distribution

International distribution in the countries of China and Republic of Korea.

Key facts

Status
Ongoing
Initiation date
2022-04-27
Report date
2022-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2022