Reported Jun 22, 2022 · Ongoing
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Micro Therapeutics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro Therapeutics, Inc. · 9775 Toledo Way · Irvine, CA · 92618-1811
Is this the product you have?
- AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Lot codes and dates
- Product NumberQC-4-12-HELIX
- UDI-DI (GTIN) Code00847536029590
- Lot NumberB240079
- Product NumberQC-10-30-3D
- UDI-DI (GTIN) Code00847536030138
- Lot NumberB240084
- Amount recalled
- 96 systems
Why it was recalled
Due to incorrect size and configuration labeling of the detachable coil system.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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