AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Recall
- Recall Number
- Z-1261-2022
- Event Number
- 90178
- Firm
- Micro Therapeutics, Inc.
- FEI Number
- 3004904811
- Product Code
- HCG
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- April 27, 2022
- Address
- 9775 Toledo Way, Irvine, CA, 92618-1811
Description
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Due to incorrect size and configuration labeling of the detachable coil system.
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 [email protected].
International distribution in the countries of China and Republic of Korea.
96 systems