BEUDAMED
    FDA Enforcement Class II 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 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2552-2016
    Event ID
    74781
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Reshape Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    May 4, 2016
    Classification Date
    August 17, 2016
    Termination Date
    August 17, 2016
    Address
    100 Calle Iglesia, N/A, San Clemente, CA, 92672-7502, United States

    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.

    Code Info

    160317-001, 160371-002, 160317-003, 160324-010.

    Distribution

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

    Quantity

    56 units