BEUDAMED
    FDA Recall Terminated

    Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis

    Recall: Z-0835-2019 · Initiated January 22, 2019

    Recall

    Recall Number
    Z-0835-2019
    Event Number
    81924
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 22, 2019
    Terminated
    March 26, 2019
    Address
    12050 S Lone Peak Pkwy, Draper, UT, 84020-9414

    Description

    Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis

    Reason

    This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

    Action

    The firm began disseminating the notices by letter on 01/22/2019. The notices explained the issue and advised the consignee to follow the guidelines and instructions provided in the Edward SAPIEN3 Commander delivery system training material for device preparation and use. Updated instructions for use will be disseminated in the near future.

    Distribution

    WorldwideDistribution

    Quantity

    159,448 units