BEUDAMED
    FDA Enforcement Class II 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 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1982-2013
    Event ID
    65855
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Endogastric Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    June 6, 2013
    Classification Date
    August 17, 2013
    Termination Date
    April 9, 2014
    Address
    8210 154th Ave NE, N/A, Redmond, WA, 98052-3877, United States

    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.

    Code Info

    UN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014) and following LOT numbers: 401132, 401147, 401152, 401156, 401159, 401167, 401207, 401214, 401219, 401220, 401225, 401227, 401230, 401233, 401236, 401246, 401248, 401251, 401257, 401258, 401259, 401267, 401269, 401271, 401274, and 401276. EXPIRED devices with Expired dates (1/31/2013, 2/28/2013, 3/31/2013 4/30/2013, 5/31/2013, 6/30/2013, and 7/31/2013) and following LOT numbers: 400923, 400927, 400934, 400937, 400940, 400943, 400949, 400961, 400963, 400973, 400976, 400979, 400980, 400981, 400984, 400986, 400992, 400994, 400997, 400998, 401004, 401005, 401009, 401012, 401016, 401017, 401024, 401026, 401029, 401056, 401058, 401059, 401060, 401061, 401062, 401063, 401065, 401072, 401074, 401076, 401079, 401084, 401085, 401092, 401094, 401107, 401114, 401115, 401121, 401129, and 401130.

    Distribution

    Distributed nationwide and Italy.

    Quantity

    5192 units in the US and 41 units outside the US