Reported Jun 5, 2024 · Ongoing
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software…
Lucid Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lucid Diagnostics, Inc. · 200 Foxborough Blvd Ste 300 · Foxboro, MA · 02035-2872
Is this the product you have?
- Brand NameEsophaCap
- Product Name
EsophaCap (20mm diameter20
- pores/inch) Model/Catalog NumberEC20T20VI
- Software VersionN/A
- Product DescriptionEsophaCap is pouched as individual units. 10 units go into a shelf-box
- ComponentNo
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published EC20T20VILot Code: Product Sent to Clinical Site — 00860007510953GTIN Number: 00860007510953 EC20T20VILot #'s: 462 (Qty: 25), 486 (Qty: 32), 501 (Qty:100) Product at Distributor in Quarantine — 00860007510953GTIN Number: 00860007510953 — Lot #'s: 486 (Qty: 18), 540 (Qty: 97) - Amount recalled
- 157 units (US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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