AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
FDA Recall Z-1261-2022 · Posted None
Advertisement
Recalling FirmMicro Therapeutics, Inc.
Recall StatusOpen, Classified
Product CodeHCG
Date Initiated2022-04-27
Product Quantity96 systems
Reason for Recall
Due to incorrect size and configuration labeling of the detachable coil system.
Firm Action
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].
Root Cause
Labeling Change Control
Distribution Pattern
International distribution in the countries of China and Republic of Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement