AxiumTM recallZ-1261-2022 · Micro Therapeutics, Inc. · initiated Apr 27, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Micro Therapeutics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect size and configuration labeling of the detachable coil system.
FDA root cause category: Labeling Change Control
What the company is doing
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].
Recall details
- Recall number
- Z-1261-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 27, 2022
- Recalling firm
- Micro Therapeutics, Inc.
- Quantity
- 96 systems
- Product code
- HCG
- FDA submissions
- K203432
- Distribution
- International distribution in the countries of China and Republic of Korea.
Product description
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- AxiumTM QC-4-12-HELIXMicro Therapeutics, Inc. · Device, Vascular, for Promoting Embolization1 recall2 reports
- AxiumTM QC-10-30-3DMicro Therapeutics, Inc. · Device, Vascular, for Promoting Embolization1 recall2 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K203432 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Axium™ Detachable Coil System PC-3-8-HELIXMicro Therapeutics, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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