ClariTEE TEE Probe (ImaCor) – Articulation Error (2025)
Production assembly error can cause incorrect probe articulation during medical procedures.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Brand
ImaCor Inc.
Lot Codes / Batch Numbers
Model CLT-010, UDI-DI 00861589000108, Lot number: 20261209.
Products Sold
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
ImaCor Inc. is recalling ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use due to Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026