ImaCor ClariTEE Miniaturized TEE probe recall — FDA Z-0038-2026
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.
Overview of recall records associated with ImaCor Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
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.
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…
This page summarizes recall records in which the official source identifies ImaCor Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.