BEUDAMED
    FDA Recall Terminated

    InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.

    Recall: Z-1621-2014 · Initiated March 14, 2014

    Recall

    Recall Number
    Z-1621-2014
    Event Number
    67964
    Firm
    InterValve Inc
    FEI Number
    3010133561
    Product Code
    OZT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 14, 2014
    Posted
    May 15, 2014
    Terminated
    June 16, 2014
    Address
    16200 State Highway 7, Unit B, Minnetonka, MN, 55345

    Description

    InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.

    Reason

    Leak issues were discovered through accelerated age testing.

    Action

    Since this recall involved only 2 units at one site, the devices were picked up by the sales representative. There was no written communication regarding this. The site was verbally informed that there was a problem with the device that manifests itself during prepping and the devices need to be retrieved for retest.

    Distribution

    Distribution to TN only

    Quantity

    2