Z-1900-2024Class II

Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI...

Name: Z-1900-2024 Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI...
Creator: Lucid Diagnostics, Inc.
Published: 2024-04-24
License: https://open.fda.gov/license/

Lucid Diagnostics, Inc. / initiated 2024-04-24 / Open, Classified

FDA source

Lucid Diagnostics, Inc. began a recall of Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description... on 2024-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1900-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-24
Posted: 2024-05-24
Recalling firm: Lucid Diagnostics, Inc.
Product: 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
Product code: EOX Esophagoscope (Flexible Or Rigid)
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.
FDA root cause: Under Investigation by firm
Action: On April 24, 2024 direct customers were sent notification letters via email with recall instructions. Effectiveness Checks: The signed Acknowledgment and Receipt forms must be returned along with any product that is still in-hand at the clinical sites. Customer Follow-up: Follow-ups will be conducted via phone and email for customers who do not respond. Returned Product: Returned product will be put into quarantine until all recalled product is under our control. Access is limited to authorized personnel only. It will then be destroyed. Destruction: Devices will be cut and disposed of. Once the string is cut, the device will no longer be functional to use. PD1 Quarantined: 115 PD2 Quarantined: 99 Preventive Action Taken by Firm: All EsophaCap product in the field will be returned to Lucid Diagnostics. The EsophaCap product is no longer manufactured for the clinical studies. The last manufactured product was February 2023.
Quantity in commerce: 220 units (US)
Distribution: US Nationwide distribution in the states of MN, MD.
Product codes and lots: Lot Code: Product sent out to clinical site: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 483 (Qty: 120), 502 (Qty: 100) Product at Distributor in Quarantine: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 539 (Qty: 99)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1900-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1899-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24
Z-1900-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

Product code EOX

K203450Class IIEsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLC / cleared 2021-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)