FDA recall Z-1900-2024

Lucid Diagnostics, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution in the states of MN, MD.

Key facts

Status
Ongoing
Initiation date
2024-04-24
Report date
2024-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Foxboro, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1900-2024