ClariTEE Miniaturized TEE Probe Control Reversal in 45 Units
ImaCor is recalling 45 units of the ClariTEE Miniaturized TEE probe (Model CLT-010) due to a manufacturing defect causing reversed lever control. The device's forward lever movement bends the probe tip forward instead of backward, posing a clinical hazard.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with a control defect posing risk of harm during clinical use. No injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
ImaCor Inc. is recalling 45 ClariTEE Miniaturized TEE (transesophageal echocardiography) probes, Model CLT-010, designed for use with ImaCor's Mobile Ultrasound system (model ZHH).
A production assembly error causes reversed articulation of the probe tip. Moving the control lever forward causes the probe tip to anteflex (bend forward) instead of the intended retroflex (bending backward). This reversed control behavior could lead to unintended probe movement during clinical use.
The affected units (Lot 20261209) were distributed nationwide to healthcare facilities in South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Healthcare facilities with these devices should discontinue use and contact ImaCor for replacement or further guidance.
The recalled product
- Product
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Manufacturer
- ImaCor Inc.
- Hazard
- reversed-articulation
- control-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model CLT-010
- UDI-DI 00861589000108
- Lot number: 20261209.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03