BEUDAMED
    FDA Recall Terminated

    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 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 obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    Recall: Z-2552-2016 · Initiated May 4, 2016

    Recall

    Recall Number
    Z-2552-2016
    Event Number
    74781
    Firm
    Reshape Medical Inc 100 Calle Iglesia San
    FEI Number
    3013508647
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 4, 2016
    Terminated
    August 17, 2016
    Address
    Clemente, CA, 92672-7502

    Description

    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 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 obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    Reason

    Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.

    Action

    A Dear Doctor letter dated May 4, 2016, was sent to all the customers to inform them that ReShape Medical is recalling ReShape Integrated Dual Balloon System, Gen 1 due to a suspected misalignment of the connection between the proximal balloon cap and the delivery catheter. The letter informs the customers that the possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure. Customers are informed of the planned field correction and if customers have any questions then they're instructed to contact ReShape Medical Customer Service at (844) 937-7374. For further questions please call (949) 429-6680 ext. 106

    Distribution

    US: Distribution to the states of : NY, OH and CA.

    Quantity

    56 units