Foxboro, MA, United States
Lucid Diagnostics, Inc. recalls
1 recall recorded since 2018, most recently on 24 April 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 April 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1900-2024, Z-1899-2024
- 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 sh
- 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 sh
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.