Lucid Diagnostics, Inc.: Device Recall

Recall #Z-1899-2024 · 04/24/2024

Class II: Risk

Recall Details

Recall Number: Z-1899-2024
Classification: Class II
Product Type: Device
Recalling Firm: Lucid Diagnostics, Inc.
Status: Ongoing
Date Initiated: 04/24/2024
Location: Foxboro, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 157 units (US)

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.

Product Description

Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No

Distribution Pattern

US Nationwide distribution in the states of MN, MD.

Other Recalls by Lucid Diagnostics, Inc.

Class II: Risk 04/24/2024

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.

View all recalls by Lucid Diagnostics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.