ImaCor recalls 45 CLT-010 miniaturized TEE probes nationwide in five states after a production assembly error risks reversed articulation. The device is used with ImaCor model ZHH and Mobile Ultrasound. Stop using the device immediately and follow the manufacturer’s recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ImaCor Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The ClariTEE CLT-010 is a miniaturized transesophageal echocardiography probe used with dedicated ultrasound systems.
A reversed articulation could misdirect the probe tip during procedures, potentially compromising guidance during imaging.
This recall is not described as part of a broader industry pattern.
Clinicians may need to pause procedures on affected patients and switch to alternative imaging devices.
FDA recall page linked in enforcement report Z-0038-2026.
Refunds or replacements timelines are determined by ImaCor; expect several weeks.
Keep recall notice, photos of device label, and correspondence with ImaCor for records
Model: CLT-010. UDI-DI: 00861589000108. Lot number: 20261209. Quantity: 45 units. Distribution: US nationwide in SC, NJ, PA, FL, GA. Sold with ImaCor Mobile Ultrasound system, ImaCor ZHH.
No injuries or incidents have been reported in the data provided.
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