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ClariTEERecalls & reported problems

Imacor Inc · TEE ultrasound probe, single use, EO Sterile · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 29, 2025Open, Classified

    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.

    Z-0038-2026 · Root cause: Process control · FDA record ↗

  2. Sep 16, 2024Open, Classified

    Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.

    Z-0231-2025 · Root cause: Process control · FDA record ↗

Other Transducer, Ultrasonic, Diagnostic devices

All Transducer, Ultrasonic, Diagnostic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.