Recall Z-1261-2022— Micro Therapeutics, Inc.

Name: FDA recall Z-1261-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-27

Class II · Ongoing

Class II FDA medical device recall by Micro Therapeutics, Inc., initiated 2022-04-27. It names one FDA 510(k) clearance: K203432. Product: AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;. Reason: Due to incorrect size and configuration labeling of the detachable coil system..

Recalling firm: Micro Therapeutics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K203432 — Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular·cleared 2021-07-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.