BEUDAMED
    FDA Recall Terminated

    Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter

    Recall: Z-0347-2018 · Initiated November 28, 2017

    Recall

    Recall Number
    Z-0347-2018
    Event Number
    78716
    Firm
    Stryker Neurovascular
    FEI Number
    3008853977
    Product Code
    NRY
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 28, 2017
    Terminated
    April 28, 2020
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter

    Reason

    Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.

    Action

    The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.

    Distribution

    OUS only - NL, FR, IT, DE, BE