The Recall Desk
HighFDA (Devices)·Z-1899-2024·Announced 2024-06-05

EsophaCap esophageal diagnostic sponge recalled for detachment risk

Lucid Diagnostics recalls EsophaCap esophageal diagnostic sponges due to risk of sponge detachment from string during device removal. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with a documented risk of device component detachment during a clinical procedure. No injuries, illnesses, or adverse events have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Lucid Diagnostics, Inc. is recalling EsophaCap (Model EC20T20VI), a diagnostic device. The recall affects 157 units with US distribution, primarily in Minnesota and Maryland.

EsophaCap is a device with a sponge attached to a string that is placed in and removed from a patient. During removal, the sponge may detach from the string, particularly at the esophageal sphincters—the narrowest parts of the esophageal passage. These narrow areas are located at the gastroesophageal junction and between the pharynx and esophagus. Detachment could result in the sponge remaining in the esophagus.

No injuries or illnesses have been reported in relation to this defect. Patients who have received this device should contact their healthcare provider to determine whether any follow-up evaluation is needed.

Affected lot numbers are 462, 486, 501, and 540. These units are located either at clinical sites or in quarantine at distributors.

The recalled product

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
Manufacturer
Lucid Diagnostics, Inc.
Category
Medical Device — Diagnostic / Endoscopy
Hazard
  • device-detachment
  • foreign-body-retention

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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
  • Lot #'s: 486 (Qty: 18)
  • 540 (Qty: 97)

Distribution

Distributed nationwide across the United States.

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