BEUDAMED
    FDA Recall 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 · Initiated October 14, 2016

    Recall

    Recall Number
    Z-0392-2017
    Event Number
    75475
    Firm
    Reshape Medical Inc 100 Calle Iglesia San
    FEI Number
    3013508647
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 14, 2016
    Posted
    November 10, 2016
    Terminated
    January 24, 2017
    Address
    Clemente, CA, 92672-7502

    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.

    Action

    ReShape sent a customer notification letter dated October 14, 2016 was sent to customers to inform them that ReShape Medical is recalling the Integrated Dual Balloon System due to customer reports of instillation fluid leaking during the device inflation procedure. The letter informs the customers that any instillation fluid leakage during the inflation process will cause an incomplete balloon fill and require immediate removal of the device. Customers are instructed to contact ReShape Medical Customer Service at (844) 9377374 for any questions related to the product returns.

    Distribution

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

    Quantity

    114 units