BEUDAMED
    FDA Recall Terminated

    Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)

    Recall: Z-0849-05 · Initiated April 28, 2005

    Recall

    Recall Number
    Z-0849-05
    Event Number
    32030
    Firm
    Edwards Lifesciences Llc One Edwards Way
    FEI Number
    2015691
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2005
    Posted
    May 18, 2005
    Terminated
    October 16, 2012
    Address
    Irvine, CA, 92614-5688

    Description

    Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)

    Reason

    Potential for deployment difficulties.

    Action

    Recall was by voice mail and regular postal service on 4/28/2005 in the USA, in Europe recall began May 2, 2005. Recall notification is complete, unused product is being returned.

    Distribution

    Nationwide and Europe

    Quantity

    537