FDA Device recall Z-1261-2022
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX
- FDA Device
- Class II
- ongoing
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX by Micro Therapeutics, citing due to incorrect size and configuration labeling of the detachable coil system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1261-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-27 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Micro Therapeutics |
| Distribution | n/a |
Product
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Reason
Due to incorrect size and configuration labeling of the detachable coil system.
Identifiers
| code_info | Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D…Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1261-2022%22
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