AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Company
- Micro Therapeutics Inc
- Recall Initiated
- April 27, 2022
- Recall Number
- Z-1261-2022
- Quantity
- 96 systems
- Firm Location
- Irvine, CA
Reason for Recall
Due to incorrect size and configuration labeling of the detachable coil system.
Distribution
International distribution in the countries of China and Republic of Korea.
Lot / Code Info
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
Root Cause
Labeling Change Control
Action Taken
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.