Z-1261-2022Class II

AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D

Name: Z-1261-2022 AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D
Creator: Micro Therapeutics, Inc.
Published: 2022-04-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-04-27 / Open, Classified / root cause: labeling and UDI

FDA source

Micro Therapeutics, Inc. began a recall of AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D on 2022-04-27. FDA classified it as Class II and gives the reason as "Due to incorrect size and configuration labeling of the detachable coil system". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1261-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-27
Posted: 2022-06-13
Recalling firm: Medtronic, Inc.
Product: AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Product code: HCG Device, Neurovascular Embolization
Reason for recall: Due to incorrect size and configuration labeling of the detachable coil system.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 96 systems
Distribution: International distribution in the countries of China and Republic of Korea.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1261-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1261-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-22	2022-06-13

Product code HCG

K203432Class IIAxium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular / cleared 2021-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)