CLASS II ONGOING Device recall · Reported 22 Jun 2022 · FDA Enforcement Report

Axium Detachable Coil System recalled by Micro Therapeutics

Micro Therapeutics is recalling Axium Detachable Coil System. The recall was initiated on 27 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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

Quantity recalled96 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1261-2022
FDA event ID: 90178
Recalling firm: Micro Therapeutics, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Apr 2022
FDA classified: 13 Jun 2022
Reported: 22 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Apr 2022	Recall initiated by company
13 Jun 2022	Classified by FDA	+47 days
22 Jun 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to incorrect size and configuration labeling of the detachable coil system.

Product as listed by the FDA

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

Where it was distributed

International distribution in the countries of China and Republic of Korea.

Questions about this recall

Why was it recalled?

Due to incorrect size and configuration labeling of the detachable coil system.

Which lots are affected?

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

Where was it sold?

International distribution in the countries of China and Republic of Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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