ImaCor Inc. recalls ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TE…

Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

ImaCor, Inc. notified consignees on 08/29/2025 via email. Consignees were instructed to Immediately discontinue use of the affected ClariTEE probes, quarantine all affected units in inventory, confirm receipt of this notice, return all affected units to ImaCor, and complete and return the response form.

• FDA enforcement recordOfficial FDA database entry for Z-0038-2026
• FDA 510(k) clearance · K220490The device's official FDA premarket clearance record
• FDA device classification · ITXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ImaCor 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.