AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Reported: June 22, 2022 Initiated: April 27, 2022 #Z-1261-2022
Product Description
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.
Details
- Recalling Firm
- Micro Therapeutics, Inc.
- Units Affected
- 96 systems
- Distribution
- International distribution in the countries of China and Republic of Korea.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;. Recalled by Micro Therapeutics, Inc.. Units affected: 96 systems.
Why was this product recalled? ▼
Due to incorrect size and configuration labeling of the detachable coil system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2022. Severity: Moderate. Recall number: Z-1261-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11