AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX — Class II medical device recall Z-1261-2022
Ongoing recall by Micro Therapeutics, Inc., reported 2022-06-22. Due to incorrect size and configuration labeling of the detachable coil system.
| Recall number | Z-1261-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics, Inc., Irvine, CA, United States |
| Recall initiated | 2022-04-27 |
| Classified | 2022-06-13 |
| Reported by FDA | 2022-06-22 |
| Countries outside the US | CN, KR |
| Quantity | 96 systems |
| Reason classes | labeling, device malfunction |
| UPC / GTIN / UDI-DI | 00847536029590, 00847536030138 |
| Lot numbers | B240079, B240084 |
| Model numbers | QC-10-30-3D, QC-4-12-HELIX |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1261-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.