MICROVENTION INC. recalls Microvention

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

On December 11, 2024, MicroVention Eurpose SARL dba Terumo Neuro intiated a "Urgent Medical Device Recall" via mail. Terumo Neuro asked consignees to take the following actions: 1. Review Inventory 2. Inform and forward recall notice 3. Return Product 4. Contact Quality Department 5. Replacement or Credit of returned devices 6. Adverse reaction or quality problems experienced with the use of this product may be reported to your local MicroVention Terumo Sales Representative or the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• FDA enforcement recordOfficial FDA database entry for Z-0990-2025
• FDA 510(k) clearance · K101542The device's official FDA premarket clearance record
• FDA device classification · DQYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1250The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MICROVENTION INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.