BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 24, 2024

    Recall

    Recall Number
    Z-1900-2024
    Event Number
    94510
    Firm
    Lucid Diagnostics, Inc.
    FEI Number
    3016490370
    Product Code
    EOX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 24, 2024
    Posted
    May 24, 2024
    Address
    200 Foxborough Blvd, Ste 300, Foxboro, MA, 02035-2872

    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.

    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.

    Distribution

    US Nationwide distribution in the states of MN, MD.

    Quantity

    220 units (US)