Micro Therapeutics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1261-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 27, 2022

Date Posted: June 22, 2022

Recall Number: Z-1261-2022

Event ID: 90178

Reason for Recall:

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

Status: Ongoing

Product Quantity: 96 systems

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated