BEUDAMED
    FDA Recall Terminated

    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

    Recall: Z-0918-2014 · Initiated January 20, 2014

    Recall

    Recall Number
    Z-0918-2014
    Event Number
    67362
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    1713910
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 20, 2014
    Posted
    February 3, 2014
    Terminated
    March 24, 2014
    Address
    12050 Lone Peak Pkwy, Draper, UT, 84020-9414

    Description

    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

    Reason

    Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.

    Action

    Edwards Lifesciences issued an Urgent Product Notice to all customers. Letters were sent via Fed Ex on 01/20/14. The letter outlines steps to be taken to enable a valve to fit into the open orifice, and allow the valve to be crimped according to normal instructions. Customers were instructed to forward the Urgent Product Notification letter to necessary personnel within their organization. Customers were also instructed to acknowledge they have reviewed and understand the notification letter by signing and dating the form included with the letter. Customers with questions were instructed to contact their Edwards Clinical Specialist.

    Distribution

    Nationwide Distribution

    Quantity

    422