Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1900-2024 — 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

U.S. FDA — Device Enforcement · United States · 2024-04-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1900-2024
Date of alert
2024-04-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Lucid Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860007510977
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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