BEUDAMED
    FDA Recall Terminated

    The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156

    Recall: Z-1433-2021 · Initiated March 26, 2021

    Recall

    Recall Number
    Z-1433-2021
    Event Number
    87671
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    JCW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 26, 2021
    Terminated
    March 4, 2024
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the fluid within the system from the reservoir via the pump and into the cylinders, the product creates an erection in men who have chronic, organic, erectile dysfunction. Part Number: 720185-01, 72404156

    Reason

    An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.

    Action

    On 3/25/2021, BCS issued an Urgent Medical Device Removal notice via letter to customers notifying them certain serial numbers of AMS 700 Reservoirs may have been incorrectly labeled.

    Distribution

    Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal

    Quantity

    23 units