FDA Medical Device Recalls (openFDA)
Lucid Diagnostics, Inc.: 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
- Recall number
- Z-1899-2024
- Recalling firm
- Lucid Diagnostics, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2024-04-24
- Posted
- 2024-05-24
- Terminated
- not on file
- 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.
- 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
- 157 units (US)
- Distribution
- US Nationwide distribution in the states of MN, MD.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K203450"]
- PMA numbers
- not on file
- Product code
- EOX
- Firm FEI
- 3016490370
- Firm city
- Foxboro
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28