Lucid Diagnostics, Inc. is recalling 377 units of EsophaCap sponges because the sponge may detach from its string while being removed from a patient. The detachment is most likely to occur at the narrowest parts of the throat, such as the upper or lower esophageal sphincters. This recall includes models EC20T20VI and EC25T10VI that were distributed to clinical sites in Minnesota and Maryland or held at distributors.
If the sponge detaches from the string during removal, it may remain lodged in the patient's esophagus or throat. This creates a choking hazard or may require an additional medical procedure to retrieve the sponge safely.
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Sources: FDA iRES ยท Raw API Response
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