FDA Medical Device Recalls (openFDA)
Micro Therapeutics, Inc.: AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Recall number
- Z-1261-2022
- Recalling firm
- Micro Therapeutics, Inc.
- Product
- AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
- Status
- Open, Classified
- Initiated
- 2022-04-27
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- Quantity
- 96 systems
- Distribution
- International distribution in the countries of China and Republic of Korea.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K203432"]
- PMA numbers
- not on file
- Product code
- HCG
- Firm FEI
- 3004904811
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28