MICROVENTION INC. recalls MicoVention Terumo

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

On December 11, 2024, MicroVention Europe SARL aka Terumo Neuro issued a "Urgent Medical Device Recall" Notification to affected consignees via mail. Terumo Neuro asked consignees to take the following actions: 1. Review Inventory; 2. Inform and Forward Recall Notice; 3. Return Product; 4. Please complete and return the "Customer Acknowledgment Form"; 4. Contact Quality Department ; 5. Replacement or Credit of Returned Devices

• FDA enforcement recordOfficial FDA database entry for Z-1121-2025
• FDA device classification · QCAOfficial FDA classification for this device type
• 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.