Recall Z-1261-2022 ยท HCG Device, Neurovascular Embolization
Micro Therapeutics, Inc.
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
| Date | Apr 27, 2022 |
| Status | Open, Classified |
| Reason | Due to incorrect size and configuration labeling of the detachable coil system. |
| Root cause | Labeling Change Control |
| 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 represe |
| Quantity | 96 systems |
| Distribution | International distribution in the countries of China and Republic of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Jul 7, 2021 |