Recall archive / FDA device enforcement
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D; — FDA record Z-1261-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Micro Therapeutics, Inc.
- Quantity
- 96 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1261-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of China and Republic of Korea.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 22, 2022
- Recall initiation date
- Apr 27, 2022
- Center classification date
- Jun 13, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.