ImaCor recalled 45 units of the ClariTEE Miniaturized TEE probe on August 29, 2025, due to a production assembly error. The defect may cause the probe to articulate incorrectly, posing a risk to patient safety. Healthcare providers and patients must stop using the device immediately.
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
The recalled product is the ClariTEE Miniaturized TEE probe, Model Number CLT-010. It was distributed nationwide in South Carolina, New Jersey, Pennsylvania, Florida, and Georgia. The recall affects 45 units.
A production assembly error can lead to reversed articulation. When the lever is moved forward, the probe tip may anteflex instead of retroflex, risking improper usage.
No injuries or incidents have been reported as of the recall date. The risk is classified as high due to the potential for misuse.
Stop using the probe immediately. Follow recall instructions provided by ImaCor and contact your healthcare provider for guidance.
For more information, contact ImaCor Inc. via email as per the recall notification. Visit the FDA recall page at the provided URL.
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