BEUDAMED
    FDA Recall Terminated

    EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.

    Recall: Z-1982-2013 · Initiated June 6, 2013

    Recall

    Recall Number
    Z-1982-2013
    Event Number
    65855
    Firm
    Endogastric Solutions Inc
    FEI Number
    3005473391
    Product Code
    ODE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 6, 2013
    Posted
    August 17, 2013
    Terminated
    April 9, 2014
    Address
    8210 154th Ave NE, Redmond, WA, 98052-3877

    Description

    EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.

    Reason

    Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.

    Action

    Endogastric sent the Safety Alert: EndoGastric Solutions (EGS), EsophyX2 Device letter, dated June 5, 2013, to their consignees. Endogastric sent the second letter URGENT: MEDICAL DEVICE RECALL EsophyX2, dated July 26, 2013. This letter advised customers that the firm is voluntarily recalling EsophyX2 Devices with SerosaFuse Implantable Fastener and Accessories (Models R2001 and R2002) manufactured before February 2012. Customers who have UN-EXPIRED devices in their inventory are advised to discontinue use and fill out the Medical Device Recall Return Response form and return it to Endogastric. The Customer Service will contact customers with instructions on how to return the product to the company. Customers who may have EXPIRED devices are advised to with their central supply departments to ensure all identified products have been removed from inventory and destroyed. They should fill out the Medical Device Recall Return Response form with the lot numbers and quantity destroyed and return the completed form to the firm. Customers can call the Customer Service and Support at 425-307-9269, Monday through Friday, 8:00AM to 5:00 PM, Pacific Time for questions. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    Distributed nationwide and Italy.

    Quantity

    5192 units in the US and 41 units outside the US