Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software
Summary
The FDA issued a Class II for Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) M by Lucid Diagnostics, Inc.. 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 es.
Details
Source
Device Recall
External ID
Z-1899-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Product Sent to Clinical Site: Part #: EC20T20VI ; GTIN Number: 00860007510953 ; Lot #'s: 462 (Qty: 25), 486 (Qty: 32), 501 (Qty:100) Product at Distributor in Quarantine: Part #: EC20T20VI ; GTIN Number: 00860007510953 ; Lot #'s: 486 (Qty: 18), 540 (Qty: 97)
Quantity Affected: 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.
Distribution
US Nationwide distribution in the states of MN, MD.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-24
Company
Foxboro, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Lucid Diagnostics, Inc. has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lucid Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lucid Diagnostics, Inc. have FDA actions?
Lucid Diagnostics, Inc. has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1899-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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