Micro Therapeutics, Inc. AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D; Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Brand
Micro Therapeutics, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Micro Therapeutics, Inc. is recalling AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D; due to Due to incorrect size and configuration labeling of the detachable coil system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to incorrect size and configuration labeling of the detachable coil system.
Recommended Action
Per FDA guidance
On 04/27/2022, Medtronic initiated distribution of a retrieval notice via mail courier service to impacted OUS Consignees (hospital accounts) informing them that Medtronic has received reports that the incorrect size of Axium Detachable Coil System were found in device packages and has identified that two (2) production lots have been incorrectly labelled. Customers are asked to immediately take the following actions: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted products in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying suitable replacement product. 3. Complete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information. Questions should be addressed to Medtronic representatives or email the Office of Medical Affairs at rs.nvoma@medtronic.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026