BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-1900-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1900-2024
    Event ID
    94510
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Lucid Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2024
    Initiation Date
    April 24, 2024
    Classification Date
    May 24, 2024
    Address
    200 Foxborough Blvd Ste 300, Foxboro, MA, 02035-2872, United States

    Description

    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

    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.

    Code Info

    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)

    Distribution

    US Nationwide distribution in the states of MN, MD.

    Quantity

    220 units (US)