Lucid Diagnostics, Inc. recalls Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software V…

Recall date

April 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1900-2024

FDA classification

Class II

Brand / firm

Lucid Diagnostics, Inc.

Sold / distributed

US Nationwide distribution in the states of MN, MD.

Why it was recalled

The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A