ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound
FDA device recall Z-0038-2026 · posted 2025-10-03 · Open, Classified
Recall details
- Recalling firm
- ImaCor Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ITX
- Quantity affected
- 45 units
- Distribution
- US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
- Date initiated
- 2025-08-29
- Date posted
- 2025-10-03
- Location
- Jericho, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ImaCor Zura Handheld ZHH-010 (K220490) | Imacor, Inc. | 2022-04-08 |