BEUDAMED
    FDA Enforcement Class II Terminated

    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    Recall: Z-0392-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0392-2017
    Event ID
    75475
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Reshape Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2016
    Initiation Date
    October 14, 2016
    Classification Date
    November 9, 2016
    Termination Date
    January 24, 2017
    Address
    100 Calle Iglesia, San Clemente, CA, 92672-7502, United States

    Description

    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    Reason

    ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.

    Code Info

    Lot Number Expiration Date 160815-001 2018-08-07 160816-001 2018-08-07 160824-003 2018-08-18 160825-001 2018-08-18 160825-002 2018-08-18

    Distribution

    US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL

    Quantity

    114 units